Protocol summary

Study aim
To compare the effects of the Jacobson Relaxation Technique on satisfaction, fatigue, and burnout in nurses working in critical care units with a virtual reality to compare the results.
Design
A factorial, Randomized control trial design, to determine the effect of the three intervention groups and one control group on nurse satisfaction, fatigue, and burnout in critical care units.
Settings and conduct
Critical care units in Teaching Hospitals in Baghdad city, Iraq.
Participants/Inclusion and exclusion criteria
Inclusion : nurses who work in critical care units and have one year of experience or more in the same critical care unit. Exclusion: Physical Health Issues: Individuals with significant physical disabilities or chronic illnesses that could impair their ability to participate in (VR sessions or the Jacobson Relaxation Technique) or that may be exacerbated by the intervention are also excluded.
Intervention groups
Participants will exposed to one session per week regularly over eight weeks. After the last session in the eighth week, participants will give the Questionnaire format again to conduct the post-test assessment to determine the extent of the impact of each intervention and compare between groups The intervention will be done through virtual reality sessions for group (A) at a rate of one session per week, with each session lasting from 5-10 minutes in a natural environment for a period of 8 weeks. The intervention will be done on group (B) by exposing them to Jacobson's relaxation techniques for a period of 20 minutes, at a rate of one session per week for a period of 8 weeks. The third group (AB) will be intervened using both methods together: a virtual reality nature simulation session and exposing them to Jacobson's relaxation techniques, respectively, for a period of 8 weeks.
Main outcome variables
Minimizing level of fatigue, burnout for nurses.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230310057672N7
Registration date: 2025-02-22, 1403/12/04
Registration timing: prospective

Last update: 2025-02-22, 1403/12/04
Update count: 0
Registration date
2025-02-22, 1403/12/04
Registrant information
Name
Alaa Jawad
Name of organization / entity
University of Baghdad/College of Nursing
Country
Iraq
Phone
+964 1 521 1494
Email address
alaaj@conursing.uobaghdad.edu.iq
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-10, 1403/12/20
Expected recruitment end date
2025-05-10, 1404/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Virtual Reality and Relaxation Technique on Nurses' Fatigue, Burnout, and Satisfaction in Critical Care Units: A Factorial, Randomized Controlled Trial
Public title
Effect of Virtual Reality and Relaxation Technique on Nurses' Fatigue, Burnout, and Satisfaction in Critical Care Units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion: consent & compliance with all aspects of the clinical trial, methods, and providing data during the follow-up phase. Containing male and female One year of experience or more in the same critical care unit.
Exclusion criteria:
1-Physical Health Issues: Individuals with significant physical disabilities or chronic illnesses that could impair their ability to participate in (VR sessions or the Jacobson Relaxation Technique) or that may be exacerbated by the intervention are also excluded. 2-Neurological Disorders: Conditions such as epilepsy or other neurological disorders that could be triggered by (VR sessions or Jacobson Relaxation Technique) may lead to exclusion for safety reasons. 3- Participants with psychosocial factors which are not related to the workplace. 4- Participants who did not comply with the conditions of the clinical trial aspects or who did not complete the sessions in full for any reason.
Age
From 21 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
The simple random sample selection by using electronic dice draw to select the sample size. The draw was conducted using an electronic dice application on the tablet device. The electronic dice contains six serial numbers from (1-6). The odd numbers were determined for the nurses who will participate in the research sample, while the even numbers were determined for the nurses who was excluded from the research sample. Then it was presented to each individual in the sample population to be tested. To sample assign groups by using a random wheel of fortune draw (picker wheel) was used. The draw was conducted using an electronic wheel spinning application on a tablet device containing a wheel divided into twelve parts, every three parts scattered in the wheel have the same color, and it was spun up electronically randomly to ensure the best random selection and to avoid bias. Blue parts represented (A group) virtual reality sessions, red parts for (B group) Jacobson's relaxation techniques, green parts for (AB group) Jacobson's relaxation techniques and virtual reality sessions together, and yellow parts for (C group) control group. Then it was presented to each individual in the research sample to be tested. No allocation concealment will be carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
To achieve single blind in this trial, the participant is kept blinded to their group assignment (interventions and control groups) throughout the study. The data collector administers the assigned intervention (Jacobson's relaxation techniques, virtual reality sessions , and together groups ) without revealing the participant's group assignment. The researcher retains knowledge of group allocation to ensure Single blind. Interventions are randomized, and assess to level fatigue, burnout, and satisfaction without knowing the type of maneuvers received, ensuring that participants' expectations do not influence the results. These procedures reduce the influence of prior expectations and ensure an effective study.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10045
Approval date
2025-02-10, 1403/11/22
Ethics committee reference number
07

Health conditions studied

1

Description of health condition studied
Nurse satisfaction, fatigue, and burnout in critical care units
ICD-10 code
Z73.0
ICD-10 code description
Burn-out

Primary outcomes

1

Description
The primary outcome variable that may be assessing the level of nurses' fatigue and burnout.
Timepoint
Immediately before the intervention (Jacobson's relaxation techniques, virtual reality sessions, and together)
Method of measurement
Self-report Fatigue Assessment Scale, Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest. Maslach Burnout Inventory (MBI), all MBI items scored using a seven levels frequency rating from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). The burnout score level can be range from (Emotional exhaustion< 17, Depersonalization<5, Personal accomplishment > 40), indicating the lowest level of Burnout. (Emotional exhaustion> 30, Depersonalization > 12, and Personal accomplishment < 33), indicating the highest level of Burnout.

Secondary outcomes

1

Description
The secondary outcome variable that may be evaluation the level of nurses' fatigue, burnout, and satisfaction.
Timepoint
After intervention, 8 week after intervention (Jacobson's relaxation techniques, virtual reality sessions, and together).
Method of measurement
Self-report Fatigue Assessment Scale, Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.Maslach Burnout Inventory (MBI), all MBI items scored using a seven levels frequency rating from "never" to "daily." The MBI has three component scales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). The burnout score level can be range from (Emotional exhaustion< 17, Depersonalization<5, Personal accomplishment > 40), indicating the lowest level of Burnout. (Emotional exhaustion> 30, Depersonalization > 12, and Personal accomplishment < 33), indicating the highest level of Burnout.Visual analog scale for satisfaction, “I’m very satisfied “on one end “I’m not satisfied at all” on the other.

Intervention groups

1

Description
Intervention group: Group (A): Participants in the first week in this group and before intervention will give a self-report instrument for pre-test assessment. To assess the level of fatigue (Self-report Fatigue Assessment Scale) and burnout (Maslach Burnout Inventory MBI) that is fill out by the participants separately to ensure impartiality and reliability of the answer and in a time not exceeding 15 minutes. This will done in the nurses' break room and during their break only. Then the participant sits on a chair in a position that is suitable and comfortable for his body and will receive instructions on how to use Virtual Reality (VR), and then wear the virtual reality glasses connected to a special approved and reliable tablet. A video of a natural environment enhanced by virtual reality prepared for this purpose shown for 5-10 minutes. After that, the virtual reality glasses remove from the participant and immediately sterilized with a sterile solution to prevent the transmission of infection between participants. Participants will exposed to one session per week regularly over eight weeks. After the last session in the eighth week, participants will give the Questionnaire format again to conduct the post-test assessment to determine the extent of the impact of virtual reality on the level of fatigue, burnout and satisfaction among nurses
Category
Treatment - Other

2

Description
Intervention group: Group (B): Participants in the first week in this group and before intervention will give a self-report instrument for pre-test assessment. To assess the level of fatigue (Self-report Fatigue Assessment Scale) and burnout (Maslach Burnout Inventory MBI), that is filled out by the participants separately to ensure impartiality and reliability of the answer and in a time not exceeding 15 minutes. This will done in the nurses' break room and during their break only. Then the participant sits on a chair in a position that is suitable and comfortable for his body and will receive the researcher's guidance. To apply the Jacobson muscle relaxation technique on his entire body by tightening and relaxing the muscles of the body, starting with the leg muscles and moving to the facial and jaw muscles, based on the Jacobson technique guide. The session takes only about 20 minutes to complete the technique Participants will exposed to one session per week regularly over eight weeks. After the last session in the eighth week, participants will give the Questionnaire format again to conduct the post-test assessment to determine the extent of the impact of the Jacobson relaxation technique on the level of fatigue, burnout and satisfaction among nurses
Category
Treatment - Other

3

Description
Intervention group: Group (AB): Participants in the first week in this group and before intervention will be given a self-report instrument for pre-test assessment. To assess the level of fatigue (Self-report Fatigue Assessment Scale) and burnout (Maslach Burnout Inventory MBI), that is fill out by the participants separately to ensure impartiality and reliability of the answer and in a time not exceeding 15 minutes. This will done in the nurses' break room and during their break only. The participant will sits in a chair in a comfortable position for his body and will receive instructions on how to use Virtual Reality (VR), and then wear wear the VR glasses connected to a special approved and reliable tablet. A video of a natural environment augmented with VR prepared for this purpose shown for 5-10 minutes. After that, the VR glasses removed from the participant and immediately sterilized with a sterile solution to prevent the transmission of infection between participants. The participant given a ten-minute break. The researcher will guides the participant to sit on the chair in a position that is suitable and comfortable for his body as well to apply the Jacobson technique for muscle relaxation on his entire body by tightening and relaxing the muscles of the body starting with the leg muscles and moving to the facial and jaw muscles based on the Jacobson technique guide. The session takes only about 20 minutes to complete the technique. Participants are exposed to one session per week regularly over eight weeks. After the last session in the last week, participants are given the assessment form again to conduct the post-test assessment to determine the extent of the impact of combining of Virtual Reality and Jacobson muscle relaxation technique on the level of fatigue, burnout and satisfaction among nurses
Category
Treatment - Other

4

Description
Control group: group(C): Participants in the first week in this group will be given a self-report instrument for pre-test assessment, to assess the level of fatigue and burnout that is filled out by the participants separately to ensure impartiality and reliability of the answer and in a time not exceeding 15 minutes. This is done in the nurses' break room and during their break only. and after eight weeks a post-test done without any intervention on group participants.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Multicenter, Critical care units in teaching hospitals in Baghdad city, Iraq.
Full name of responsible person
Alaa Jawad Kadhim, Mahmood Radhi Dawood
Street address
Baghdad, Street 729
City
Baghdad
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Baghdad/college of Nursing
Full name of responsible person
Professor. Wissam Jabbar Qasim, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The authors of the trial are the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
University of Baghdad/college of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Baghdad/college of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/

Person responsible for updating data

Contact
Name of organization / entity
University of Baghdad/college of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. Sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for five months after the publications, after you are approved to register on the Iranian clinical trials website
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. E-Mail: alaaj@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
The processes involved in accessing this documentation are possible via email: alaaj@conursing.uobaghdad.edu.iq, the first and last name of authors, trial' title variable and the trial Id.
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors. The four groups were added individually in each field. We hope that the modifications will be appropriate to the design of the experiment. With many thanks and appreciation for your patience.
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