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International Journal of Nursing Studies 74 (2017) 4452

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International Journal of Nursing Studies


journal homepage: www.elsevier.com/locate/ijns

The eects of family-centered aective stimulation on brain-injured MARK


comatose patients level of consciousness: A randomized controlled trial

F. Salmania, E. Mohammadia, , M. Rezvanib, A. Kazemnezhadc
a
Department of Nursing, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
b
Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
c
Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

A R T I C L E I N F O A B S T R A C T

Keywords: Background: Despite the well-dened eects of sensory stimulation, the knowledge of the pure eects of af-
Traumatic brain injury fective stimulation is scarce.
Aect Objective: To evaluate the eects of family-centered aective stimulation on the level of consciousness among
Sensory comatose patients with brain injuries.
Stimulation
Design: This study was designed as a three-group double-blinded Randomized Controlled Trial.
Consciousness
Methods: Ninety consecutive patients with traumatic brain injuries and a Glasgow Coma Scale score of 58 were
Coma
selected. Patients were randomly allocated to an experimental, a placebo, and a control group using permuted
block randomization. Aective stimulation intervention was provided to patients in the experimental group by
their family members twice a day during the rst seven days of their hospitalization. In the placebo group, a
sensory stimulation program was implemented by a xed trained person who was not familiar with the patients.
Patients in the control group solely received sensory stimulation which was routinely provided to all patients.
The level of consciousness among the patients using the Glasgow Coma Scale and Coma Recovery Scale-Revised
were measured both before and after a family visit. The SPSS software (version 17.0) was used to analyze the
data through running the one-way and the repeated measure analyses of variance.
Results: Despite an insignicant dierence among the groups regarding baseline level of consciousness, the
results of the one-way analysis of variance revealed at the seventh day of this study, however, the level of
consciousness in the experimental group was signicantly higher (9.1 2.1) than the placebo (7.2 1.1), the
control groups (6.6 1.7) (P < 0.001), subsequently. Moreover, at the seventh day of the study, the Coma
Recovery Scale score in the experimental group (11.9 3.7) was signicantly greater than the placebo
(9.0 2.0) and the control (6.6 1.6) groups (P < 0.001). Recovery rate and eect size values also con-
rmed the greater eectiveness of aective stimulation compared with pure sensory stimulation.
Conclusion: Our ndings in this study indicate that early family-centered aective stimulation is more eective
than sensory stimulation in improving the level of consciousness among comatose patients with brain injuries.
Family-centered aective stimulation is recommended to be integrated into the nursing curricula and routine
care plans for comatose trauma patients in intensive care units.

What is already known about this topic? What this paper adds

Sensory stimulation is eective for improving the level of con- Family-centered aective stimulation is more eective than sensory
sciousness among comatose patients. stimulation in improving the level of consciousness among comatose
Although family involvement in care delivery is an accepted prac- patients.
tice in general hospital wards, it cannot be freely practiced in in- Family-centered aective stimulation is distinct and beyond con-
tensive care units due to the critical conditions of patients and the ventional sensory stimulation and can be integrated into routine
specialized care services provided in these units. care plans for comatose trauma patients in intensive care units.
Little is known about the eects of aective stimulation.


Corresponding author.
E-mail address: mohamade@modares.ac.ir (E. Mohammadi).

http://dx.doi.org/10.1016/j.ijnurstu.2017.05.014
Received 25 January 2017; Received in revised form 29 May 2017; Accepted 30 May 2017
0020-7489/ 2017 Elsevier Ltd. All rights reserved.
F. Salmani et al. International Journal of Nursing Studies 74 (2017) 4452

1. Introduction any dierences in the eects of stimulation provided by familiar and


unfamiliar people. In other words, comatose patients may perceive a
Traumatic brain injuries are among the most common causes of stimulation provided by a familiar person dierently from a stimulation
disability, mortality, and hospitalization in intensive care units (ICU) provided by an unfamiliar one (Eysenck and Flanagan, 2001; Kreibig
around the world (Grafman and Salazar, 2015). Most patients with et al., 2013). As such, Harmon-Jones et al. (2013) recommended that in
traumatic brain injuries experience alterations in the level of con- order to produce more signicant results, aective stimulation should
sciousness (LOC) for dierent periods (Doan et al., 2016). be provided by the most familiar people to the clients, i.e. their family
Altered LOC is associated with i) adverse eects on normal func- members (Urbenjaphol et al., 2009). On the other hand, continuous
tioning the longer the length of altered consciousness, ii) the sever the sensory stimulation provided by unfamiliar people can eventually lead
functional dysfunction, iii) the slower the recovery, and vi) the poorer to the inhabitation of the stimulation. Conclusively, the eects of sen-
the prognosis (Carlson and Louis, 2009). sory stimulation may decrease over the time and thus this stimulation
One of the most serious problems among comatose patients is sen- may no longer be interpreted by the person (Eysenck and Flanagan,
sory deprivation. It can cause dierent mental and perceptual problems 2001).
and life-threatening conditions for patients hospitalized in ICUs Beside external factors, the needs, aims, and expectations of people
(Gaugler, 2005). Peripheral sensory stimulation can hasten the process aect their feelings and perceptions. One of the most important needs
of post-traumatic brain injury brain plasticity, promote brain re- of patients hospitalized in ICUs is the emotional need to be with their
generation, improve neurologic function (Davis and Gimenez, 2003), family members. However, this need is often taken for granted (Kreibig
shorten the length of ICU stay, and alleviate anxiety (Hetland et al., et al., 2013).
2015). Currently, sensory stimulation is considered as a safe and ef- Emotions are produced when signals reach the thalamus either di-
fective therapeutic, rehabilitative, caring measure and is widely used in rectly from the sensory receptors or by descending cortical input. In
dierent care settings (Abbate et al., 2014; Kavosipour et al., 2008). other words, the character of the emotion is determined by the pattern
Although giving sensory stimulation (including auditory, visual, and of activation of the thalamus irrespective of the physiological response
tactile) to comatose patients is currently among the main components to the sensory input. the cortex is critically involved in the experience of
of critical care (Hasanzadeh et al., 2012), aective stimulation has not emotion. Following damage to certain cortical areas, there are some-
been yet considered and evaluated as a distinct care measure. Sensory times profound changes in emotional expression with little change in
stimulation and interactions necessitate family involvement in the perception or intelligence (Paradiso et al., 2016). Fig. 1 shows the ef-
process of care delivery. Though family involvement in care delivery is fects of external aective stimulation on the centers of emotional re-
an accepted practice in general hospital wards (Davidson, 2009), it sponse in the cerebral cortex, thalamus and limbic system (it was de-
cannot be freely practiced in ICUs due to the critical conditions of pa- veloped by the authors based on the explanation of the theoretical
tients and the specialized care services provided in these units (Mitchell framework).
et al., 2009). Although aective stimulation has been known theoretically to have
Numerous studies have been conducted to evaluate the eectiveness positive eects on patient outcomes, the strong empirical evidence is
of sensory stimulation in improving comatose patients LOC (Davis and needed before it can be used as a care measure in clinical settings.
Gimenez, 2003; Mahmoodi et al., 2013; Mandeep, 2012; Oh and Seo, Nonetheless, our literature review showed that there is neither ex-
2003). Moreover, some contradictory reports evaluated the eective- perimental nor clinical evidence in this area. Thus, the present study
ness of family involvement as a source of sensory stimulation was made to evaluate the eects of family-centered aective stimula-
(Hasanzadeh et al., 2012; Abbasi et al., 2009; Bassampoor et al., 2007; tion on LOC among comatose patients with traumatic brain injuries.
Gorji et al., 2014; Kalani et al., 2016; Karma and Rawat, 2006; Megha This is the main novelty of this examination.
et al., 2013; Moattari et al., 2016; Tavangar et al., 2016). So far, none of
these studies investigated the pure eects of aective stimulation on 2. Methods
patient outcomes in ICUs (Davis and Gimenez, 2003; Mahmoodi et al.,
2013; Bassampoor et al., 2007; Gorji et al., 2014; Kalani et al., 2016; 2.1. Design
Tavangar et al., 2016; Hoseini Azizi et al., 2016; Lombardi et al., 2002;
Urbenjaphol et al., 2009). This was a three-group double-blind randomized controlled trial.
Aective given stimulation by family members (henceforth referred Nurses who measured patients LOC were blind to the study aims and
to as family-centered aective stimulation) was rst introduced by interventions. Participating patients were blind to the interventions.
Abbasi et al. (2009) as a care measure which is distinct from and be- The study setting was the adult trauma care unit of a teaching hospital
yond sensory stimulation. They declared that the pure eects of family- located in Isfahan, Iran. The routine visitation protocol in the setting
centered aective stimulation on patient outcomes in ICUs had not been was thrice a week (Monday, Wednesday, and Friday) through the ward
evaluated yet (Abbasi et al., 2009). Therefore, the present study was windows and without any close physical or aective contact between
performed to examine the pure eects of family-centered aective sti- patients and their family members.
mulation on LOC among comatose patients with traumatic brain in-
juries. 2.2. Participants

1.1. Theoretical framework The inclusion criteria were aiction by a traumatic brain injury, a
Glasgow Coma Scale (GCS) score of 58, and an age of 1865. Patients
Theoretically or physiologically; a distinction between sensory and who discharged from the ICU, died, or needed an emergency operation
family-centered aective stimulation is based on three aspects namely during the study were excluded. The sample size was calculated using
psychological, cognitive, and motivational. These aspects can accel- the results reported by Abbasi et al. (2009). They reported that the
erate cognitive processes, stimulate sympathetic nervous system, and means of GCS score in their groups were 6.8 1.4 and 7.8 0.70
later promote arousal (Harmon-Jones et al., 2013). Moreover, any type (Abbasi et al., 2009). So far, with a condence level of 0.95 and a power
of aective stimulation can aect the brain, particularly the reticular of 0.90, we concluded that 30 patients were needed for each study
activating system. Activation of this system increases sympathetic ac- group. Initially, an allocation protocol was developed using the per-
tivity throughout the neither body which in turn increases the levels of mutated block randomization technique (Pocock, 2013). Then, eligible
norepinephrine at nerve terminals and causes arousal and conscious- patients were consecutively recruited and randomly allocated to an
ness (Olausson et al., 2016). A critical point is about the possibility of experimental, a placebo, or a control group based on the permuted

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F. Salmani et al. International Journal of Nursing Studies 74 (2017) 4452

Fig. 1. The theoretical framework of aective stimuli.

Eligible Patients (N=110)

Head Age :18-65 GCS: 5-8


trauma

Permutated Block Randomization

Group 1 Group 2 Group 3


Intervention (N=37) Placebo (N=36) Control (N=37)

Visiting twice a day by


Family relatives of Visiting twice a day by Visiting according to
patients a stranger the ICU routine

Death (N=3) Death (N=4) Death (N=4)

Emergency surgery (N=2)


Emergency surgery (N=1)
Emergency surgery (N=3)

Transfer (N=2)
Transfer (N=1)

Intervention Placebo Control


Completed Trial (N=30) Completed Trial (N=30) Completed Trial (N=30)
Fig. 2. Trial prole (CONSORT ow diagram).

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F. Salmani et al. International Journal of Nursing Studies 74 (2017) 4452

Table 1 2004). It contains three components namely eye opening, verbal re-
Comparing the groups regarding the patients demographic characteristics and con- sponse, and motor response and is used to assess patients reactivity.
founding variables.
GCS score ranges from 3 to 15. Score 3 represents the lowest LOC and
Demographics Case Placebo Control p-value sever neurologic disorder while score 15 shows full consciousness and
normal reactivity. Despite its usefulness for LOC assessment, GCS
N % N % N % should be used in association with other neurologic assessment tools
(Gonzalez et al., 2004) because it has several limitations. For instance,
sex Men 22 73.3 24 80 22 73.3 0.78
Woman 8 26.7 8 20 8 26.7 it does not necessarily show the extent of traumatic brain injury, cannot
education Under- 4 13.3 4 13.3 4 13.3 0.68 assess pupillary response and minor changes in the power and mobility
graduate of the extremities, and cannot be used for patients who are intubated,
Diploma 18 60 21 70 17 56.7 receive medications that alter LOC, or suer from spinal cord injuries or
post 8 26 5 16.7 9 30
orthopedic traumas (Carlson and Louis, 2009). Thus, we used CRS-R in
graduate
Diagnosis Cerebral 16 53.4 18 60 18 60 0.89 addition to GCS for LOC assessment.
Hemorrhage
MIX 4 13.3 4 13.3 2 6.7
Contusion 6 20 6 20 9 30
2.4.2. CRS-R
*DAI 4 13.3 2 6.7 1 3.3 CRS-R is a 23-item scale the items of which are hierarchically ar-
Cause Car accident 10 33.3 10 33.3 11 36.7 0.83 ranged. It contains six subscales namely audition, vision, motor, com-
Motor 16 35.3 15 50 17 56.7 munication, speech, and arousal which are scored 04, 05, 06, 03,
accident
02, and 03, respectively. Scoring is performed based the presence or
Falling 4 13.3 5 16.7 2 6.7
Mean(SD) Mean(SD) Mean(SD) 0.78 absence of specic behavioral responses to standard sensory stimula-
Age 35.4(14.2) 34.5(14) 32.9(13.6) tion. Lower CRS-R scores show reexive activity while higher scores
**Apache 2 12.8(5.4) 12.5)5.4( 12.1(4.8) 0.85 denote cognitive behaviors (Giacino et al., 2004). The concurrent va-
GCS DAY 1 5.3(0.6) 5.1(0.3) 5.3(0.8) 0.29 lidity of the CRS-R was assessed using the Disability Rating Scale which
Score
CRS DAY1 5.5(0.9) 5.1(0.8) 5.2(1) 0.41
yielded a correlation coecient of 0.9. Moreover, the stability and in-
Score ternal consistency assessments of CRS-R revealed a test-retest correla-
tion coecient of 0.94 and a Cronbachs alpha of 0.84, respectively
* DAI: Diuse Axonal Injury. (Giacino et al., 2004). We assessed the reliability of the scale through
**Apache 2: Acute physiology and chronic health evaluation. the inter-rater reliability assessment method. Therefore, seventeen pa-
tients were recruited to a pilot study and an intervention was im-
block randomization protocol (Fig. 2). Allocation numbers were gen- plemented for them. After that, two raters concurrently assessed pa-
erated using a table of random numbers. The process of sampling took tients using CRS-R. The inter-rater correlation coecient was 0.90.
place from March 2015 to June 2016.

2.4.3. Apache II
2.3. Ethical considerations APACHE II is among the instruments which are used to determine
disease severity during the rst 24 h of ICU admission. It consists of
This study obtained an ethical approval from the Ethics Committee three main parts. The rst part contains twelve items on physiological
of Tarbiat Modares University, Tehran, Iran, on April 28, 2013. parameters and LOC. The possible score on each physiological para-
Moreover, it was registered in the Iranian Registry of Clinical Trials. meter is 04. Final LOC score is calculated through subtracting GCS
The approval and the registration codes were IR.TMU.REC.1394.22 and score from 15. The total score of the physiological domain of APACHE II
IRCT201503048069N3, respectively. The family members of all parti- is 059. The second part is a 06 score which is calculated based on the
cipants were informed about the study aim. All patients were free intended patients age group. The third part is related to chronic con-
whether to participate in or to withdraw from the attendance. ditions or organ failure. The scores of these three parts are summed to
Additionally, all associated data concerning the patients were re- obtain the total APACHE II score which ranges from 0 to 71. Higher
maining condential. APACHE II score shows severer health condition (Donahoe et al., 2009).

2.4. Instruments 2.5. Intervention in the experimental group: family-centered aective


stimulation
Study data were collected through employing GCS, the Coma
Recovery Scale-Revised (CRS-R), and the Acute Physiology and Chronic In the experimental group, a close family member (father, mother,
Health Evaluation (APACHE II). spouse, child, sister, or brother) who had the strongest emotional re-
lationship with the intended patient was selected based on the re-
2.4.1. GCS commendations of the other members of the family. In parallel, two
GCS is a standard easily-interpretable scale for objective neurologic critical care nurses were provided with training about sensory-aective
assessment, the validity and reliability of which had been conrmed in stimulation, ward rules and regulations, and the importance of family
previous studies (Gill et al., 2004; Healey et al., 2003; Udekwu et al., members scheduled attendance at their patients bedside. In ICU

Table 2
Comparing the groups regarding patients GCS scores at seven measurement time points.

GCS GCS1 GCS2 GCS3 GCS4 GCS5 GCS6 GCS7 P-value For Within groups
Groups Mean(SD) Mean(SD) Mean(SD) Mean(SD) Mean(SD) Mean(SD) Mean(SD)

Intervention 5.3(0.6) 5.4(0.8) 5.8(1.2) 7(1.4) 7.7(1.9) 8.8(1.9) 9.1(2.1) p > 0.001
Placebo 5.1(0.3) 5.1(0.3) 5.2(0.5) 5.9(0.6) 6(0.9) 6.9(1.1) 7.2(1.1) p > 0.001
Control 5.3(0.8) 5.3(0.8) 5.4(0.8) 5.7(1.1) 5.7(1.2) 5.9(1.3) 6.6(1.7) p > 0.001
P-value for Between groups p = 0.29 p = 0.24 p = 0.05 p > 0.001 p > 0.001 p > 0.001 p > 0.001

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F. Salmani et al. International Journal of Nursing Studies 74 (2017) 4452

admission, either of these two nurses provided the intended patients

< 0.001
Control

Control
close family member with training about family-centered aective sti-

0.4
mulation. Training was about the rules and regulations of ICU, patients
condition, the necessity and importance of scheduled attendance at
GCS7 Group

Intervention
< 0.001 patients bedside, hand washing before entering and after leaving ICU,

< 0.001
how to establish the relationship with the patient, and how to provide
Placebo

sensory-aective stimulation. The selected family members attended


their patients bedside and provided family-centered aective stimula-
tion twice a day (at 11:00 and 15:00) for seven consecutive days
< 0.001
Control

Control

(fourteen times in total). The length of each session was 3045 min.
0.03

During the sessions, the in-charge nurse of the intended patient ac-
companied the family member in order to ensure the accurate im-
plementation of the intervention and to help and support the family
GCS6 Group

Intervention

member. At the rst session, either of the two trained nurses provided
> 0.001

> 0.001
Placebo

the intended family member with training about the family-centered


aective stimulation program and personally implemented the pro-
gram.
< 0.001
Control

Control
0.513

2.5.1. Family-centered aective stimulation consisting of sensory-aective


stimulation
Family-centered aective stimulation was a sensory-aective sti-
GCS5 Group

Intervention

mulation program which consisted of four main steps as follows.


< 0.001

< 0.001

Auditory stimulation for twenty minutes: In this step, the family


Placebo

member gently introduced himself/herself to the patient and called


patients name for several times. Then, he/she provided the patient
with information about time and place. After that, he/she talked with
< 0.001

the patient for fteen minutes about happy daily events in the family,
Control

Control

pleasant shared memories, and the health status of family members.


0.9

Sensory stimulation for ten minutes: The family member rmly


held the patients hands and caressed his/her face and body.
GCS4 Group

Intervention

Kinetic stimulation for fteen minutes: In this step, the family


Placebo

member massaged the patients hands and legs and performed passive
0.001

0.001

range-of-motion activities for several times under the in-charge nurses


supervision. Moreover, he/she changed the patients position and
Control

Control

massaged his/her back with the help of the nurse.


0.256

0.663

Aective conversation: During his/her attendance at the patients


bedside, the family member spoke with the patient about patients in-
terests, enjoyable experiences, and other family members health status
Pairwise between-group comparisons regarding patients GCS scores at seven measurement time points.

GCS3 Group

Intervention

and interests.
Placebo

0.04

0.04

2.5.2. Intervention in the placebo group


A xed trained person who was unfamiliar to all patients in the
placebo group provided them with 3045 min pure sensory (auditory,
Control

Control
0.933

0.430

tactile, and kinetic) stimulation twice a day for seven consecutive days
as follows: introduction (two minutes); providing information about
time and place (three minutes); talking about care services, treatments,
GCS2 Group

Intervention

and patients health status compared with previous days (ten minutes);
Placebo

performing nursing measures such as hemodynamic measurements or


0.251

0.251

vital signs assessments (ten minutes); touching patients, moving their


extremities, and changing their positions (twenty minutes).
Control

Control
0.976

0.313

2.5.3. Intervention in the control group


Patients in the control group did not receive any of the above
mentioned sensory or aective stimulation. Rather, they just received
GCS1 Group

Intervention

care services and sensory stimulation which were routinely provided to


Placebo

all patients in the study setting. These services and stimulation included
0.424

0.424

normal lighting of the ICU, noises of the equipment, medication ad-


ministration, and physical care services such as back and limb massage
by nurses, physical therapists, and nurse assistants. These services were
GCS Interventi on Group

also provided to the patients in the placebo and the experimental


groups. Patient-family visitation in the control group was also per-
formed according to the routine of the setting and through the ICU
Placebo Group

windows.
P- value

P value

Patients LOC was assessed by the two trained nurses using the GCS
Table 3

and the CRS-R both before and after family visitation. Both nurses were
blind to the study aims and interventions.

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F. Salmani et al. International Journal of Nursing Studies 74 (2017) 4452

Table 4
Comparing the groups regarding patients CRS-R scores at seven measurement time points.

CRS CRS 1 CRS 2 CRS 3 CRS 4 CRS 5 CRS 6 CRS 7 P-value For Within groups
Groups Mean(SD) Mean(SD) Mean(SD) Mean(SD) Mean(SD) Mean(SD) Mean(SD)

Intervention 5.4(0.8) 5.5(1.4) 6.2(1.8) 8(2.1) 9.1(2.5) 10.5(2.8) 11.9(3.7) p > 0.001
Placebo 5.1(0.8) 5.1(0.8) 5.3(0.9) 6.5(1.4) 6.8(1.6) 8.1(2.2) 9(2) p > 0.001
Control 5.2(1.3) 5.3(1.4) 5.5(1.5) 6(2.1) 6.1(2.1) 6.4(2.2) 6.6(1.6) p = 0.004
P-value for Between groups p = 0.56 p = 0.47 p = 0.07 p > 0.001 p > 0.001 p > 0.001 p > 0.001

2.6. Data analysis size. Results revealed that recovery rates in the experimental, placebo,
and control groups were 71%, 39%, and 24%. These ndings show that
Data were analyzed using the Statistical Package for Social Sciences recovery rate in the experimental group was higher than the placebo
(SPSS v. 17.0). Nominal and ordinal demographic variables were ana- and the control groups.
lyzed through the Chi-square test while interval and ratio demographic
variables were analyzed by running the one-way analyses of variance
(ANOVA). Moreover, the groups were compared with each other with 4. Discussion
regard to LOC scores via the one-way ANOVA with Tukeys post hoc
test. Besides, repeated measures ANOVA with Bonferroni post hoc test This study was designed to evaluate the eects of family-centered
were used to analyze the variations of LOC scores across the seven days aective stimulation on the LOC of comatose patients who had trau-
of the study intervention and P < 0.05 was signicant. matic brain injuries and were hospitalized in ICU. Findings indicated
the eectiveness of family-centered aective stimulation in improving
LOC among comatose patients from the third to the seventh day of the
3. Results intervention so much so that in these ve days, the dierences between
the groups with regard to patients LOC were statistically signicant.
The results of the Chi-square test and the one-way ANOVA showed Given the insignicant dierences between the groups regarding pa-
no signicant dierences between the groups with respect to the pa- tients age, gender, educational status, underlying conditions, cause of
tients gender, educational status, underlying conditions, causes of hospitalization, APACHE II score, and baseline GCS and CRS-R scores as
hospitalization, age, and baseline APACHE II, GCS, and CRS-R scores well as the presence of a control and a placebo group in the study,
(P > 0.05, Table 1). signicant dierences among the groups can be attributed to the pure
The results of the one-way ANOVA illustrated that the dierences eects of family-centered aective stimulation. Although most previous
among the groups regarding the GCS scores in the rst and the second studies reported the eectiveness of sensory stimulation in improving
days of the intervention were not statistically signicant while in days LOC, they were conducted using two-group designs (Davis and
37, the dierences were statistically signicant (Table 2). The results Gimenez, 2003; Hasanzadeh et al., 2012; Mahmoodi et al., 2013;
of the Tukeys post hoc test revealed that the dierences between the Mandeep, 2012; Oh and Seo, 2003; Abbasi et al., 2009; Bassampoor
experimental and the control groups as well as between the experi- et al., 2007; Gorji et al., 2014; Kalani et al., 2016; Karma and Rawat,
mental and the placebo groups regarding GCS scores were statistically 2006; Megha et al., 2013; Tavangar et al., 2016; Hoseini Azizi et al.,
signicant while the dierences between the placebo and the control 2016; Lombardi et al., 2002; Urbenjaphol et al., 2009; Goudarzi et al.,
groups were not statistically signicant (Table 3). The results of the 2010; Park and Davis, 2016; Puggina et al., 2011) and to evaluate just
repeated measures ANOVA also showed that the variations of GCS the eects of sensory stimulation. Thus, they failed to show the pure
scores in each study group were statistically signicant across the seven eects of aective stimulation. Taking together, our three-group
measurement time points. Moreover, a statistically signicant dier- double-blind randomized design is leading to the dierentiated study
ence was observed among the groups with respect to the mean GCS showing the eects of sensory and aective stimulation and indicated
scores across the seven measurement time points. In other words, LOC the greater eectiveness of aective stimulation in improving LOC
improvements in the experimental group (i.e. pure aective stimula- among comatose patients with traumatic brain injuries.
tion) were signicantly greater than the control and the placebo groups In contrary, some previous studies showed the positive eects of
(Table 2). sensory stimulation provided by family members on LOC while they
The results of the one-way ANOVA indicated that there were no failed to show the eects of sensory stimulation provided by unfamiliar
signicant dierences among the groups regarding CRS-R scores on persons on LOC.
days 13. However, the dierences between the groups were statisti- The results of the present study showed that after seven days of
cally signicant on days 47 (Table 4). The Tukeys post hoc test sensory and aective stimulation, the LOC of patients in the experi-
showed that in these days, CRS-R scores in the experimental group were mental group was signicantly higher than the patients in the placebo
signicantly greater than the control and the placebo groups while the and the control groups (P < 0.001). Moreover, the results of the re-
dierences between the placebo and the control groups were not sta- peated measures ANOVA for the within-subject factor of time in all
tistically signicant (Table 5). The repeated measures ANOVA also in- study groups were statistically signicant. In other words, the LOC in all
dicated that the variations of CRS-R scores in all study groups across the groups signicantly improved from the rst to the seventh days.
seven measurement time points were statistically signicant. Moreover, Therefore, LOC improvements in the experimental group were sig-
the results of this analysis showed a signicant dierence among the nicantly greater than the placebo and the control groups (P < 0.001).
groups regarding the variations of CRS-R scores across the seven mea- Consequently, recovery rates in the experimental, placebo, and control
surement time points. As shown in Table 4, improvements in the levels groups were 71%, 39%, and 24%, respectively. Moreover, eect sizes in
of CRS-R in the experimental group were signicantly greater than the the experimental and the placebo groups were 1.5 and 0.4, denoting the
placebo and the control groups. moderate and very large eect sizes of pure sensory stimulation and
Study ndings also showed that eect sizes in the experimental and family-centered aective stimulation, respectively. As mentioned in the
the placebo groups were 1.5 and 0.4, denoting moderate and very large theoretical framework section, any aective stimulation aects the
eect sizes, respectively. On the other hand, the recovery rate was also brain and particularly activates the reticular activating system, re-
calculated in order to provide more precise information about eect sulting in the increased sympathetic activity in dierent parts of the

49
F. Salmani et al. International Journal of Nursing Studies 74 (2017) 4452

body, increased norepinephrine release in nerve terminals, and greater

< 0.001
Control

Control
0.081
consciousness and arousal (Khurana, 2006). Moreover, not only aec-
tive stimulation activates the nervous system, but also stimulates its
development. The human brain responds to kindly stimulation and
CRS 7 Group

Intervention
< 0.002 behaviors through releasing some hormones from the frontal cortex.
These hormones increase the overall activity of the brain and improve
Placebo

0.002
LOC (Eysenck and Flanagan, 2001).
In line with our ndings, Moattari et al. (2016) reported that re-
covery rate among patients who received sensory stimulation from fa-
> 0.001

mily members and nurses and patients who received no sensory sti-
Control

Control
0.028

mulation were 60%, 17%, and 7%, respectively. Likewise, in the former
study, eect sizes in the family- and nurse-centered sensory stimulation
groups were 1.2 and 0.2, respectively. Nonetheless, they considered
CRS 6 Group

Intervention

family as a source of sensory stimulation and did not dierentiate it


< 0.001

< 0.001
Placebo

from aective stimulation. They simply used ve well-known sensory


stimuli based on the Western Neuro Sensory Stimulation Prole
(Moattari et al., 2016). However, in the present study, we considered
aective stimulation as an intervention which is distinct from sensory
< 0.001
Control

Control
0.460

stimulation. Besides, LOC improvement, recovery rate, and eect size


among patients receiving aective stimulation in our study were con-
siderably greater than what were reported by Moattari et al.
CRS 5 Group

Intervention

Other studies which evaluated the eects of signicant others re-


< 0.001

< 0.001

corded voices reported that recovery rates in their experimental and


Placebo

control groups were 60%90% and 0.3%23%, respectively


(Hasanzadeh et al., 2012; Bassampoor et al., 2007; Gorji et al., 2014;
Tavangar et al., 2016). Davis and Gimenez (2003) also evaluated the
< 0.001

eects of a 45-min auditory stimulation which included ten minutes of


Control

Control
0.543

family members recorded voices and 35 min of recorded voice of an


unfamiliar person, pieces of music, and ward sounds. They im-
plemented their intervention from the third day of hospital admission.
CRS 4 Group

Intervention

Recovery rates in their experimental and control groups were 35% and
Placebo

16%, respectively while eect size was 0.4 (Davis and Gimenez, 2003).
0.009

0.009

Although the ndings of these studies are in agreement with our


ndings, none of them dierentiated family-centered aective stimu-
lation from simple sensory stimulation.
Control

Control
0.199

0.902

Beside dierentiation between sensory and aective stimulation, a


strength of the present study was the more precise measurement of LOC
Pairwise between-group comparisons regarding patients CRS-R scores at seven measurement time points.

through both GCS and CRS-R. Our ndings revealed that the rst sig-
CRS 3 Group

Intervention

nicant dierences among the groups regarding GCS and CRS-R scores
Placebo

were in days 3 and 4, respectively. Most previous studies into the eects
0.083

0.083

of sensory stimulation on trauma patients assessed LOC just through


GCS which provides less precise information about LOC and the extent
of traumatic brain injuries (Hasanzadeh et al., 2012; Mahmoodi et al.,
Control

Control
0.813

0.813

2013; Oh and Seo, 2003; Bassampoor et al., 2007; Gorji et al., 2014;
Kalani et al., 2016; Tavangar et al., 2016; Puggina et al., 2011). The
only study which used both GCS and CRS-R for evaluating the eects of
CRS 2 Group

Intervention

sensory stimulation was a study made by Mandeep (2012). In that


study, Mandeep assessed patients LOC trice, i.e. at the rst, seventh,
Placebo

0.440

0.440

and fourteenth days of his intervention, and reported signicant dif-


ferences between the experimental and the control groups regarding
LOC at the seventh and the fourteenth days of his intervention. Con-
Control

Control
0.729

0.991

sequently, he recommended that in order to improve LOC, sensory


stimulation needs to be provided for two weeks. GCS score in his ex-
perimental group at day 14 was 8.46 0.9 which is lower than the
CRS 1 Group

Intervention

nal GSC score in our experimental group (i.e. 9.1 2.1), probably
Placebo

due to the fact that in Mandeeps study, sensory stimulation was pro-
0.651

0.651

vided by an unfamiliar person (Mandeep, 2012).


Our ndings also revealed that the dierence between the experi-
mental and the placebo groups with respect to patients LOC was sta-
CRS Intervention Group

tistically signicant while there was no statistically signicant dier-


ence between the control and the placebo groups. Other studies also
showed that aection-associated sensory stimulation was more eec-
Placebo Group

tive than pure sensory stimulation in attracting attention, improving


P-value

P-value

consciousness, and hastening sensory and cognitive processes (Pessoa,


Table 5

2005; Vuilleumier, 2005). Furthermore, aection can aect data coding


in the memory, resulting in better memorization of stimulation (Phelps,

50
F. Salmani et al. International Journal of Nursing Studies 74 (2017) 4452

2006). It is noteworthy that pleasant aective stimulation has greater Funding


eects on patients LOC compared with unpleasant stimulation (Lang
and Bradley, 2010). This study was supported by a grant from Tarbiat Modares
Interestingly, some studies contradict the eects of sensory stimu- University.
lation on LOC and attributed LOC improvements to spontaneous re-
covery of comatose patients (Lombardi et al., 2002; Lotze et al., 2011). Acknowledgement
However, the results of the present study illustrated that sensory-af-
fective stimulation was more eective than pure sensory stimulation in The authors would like to express their sincere appreciation to the
improving LOC among comatose patients with traumatic brain injuries. patients and their families who participated in this study.
Given the insignicant dierences among the groups regarding the
baseline APACHE II score, signicant dierences among the groups References
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