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Study to Investigate Effect of Benson's Relaxation Technique on Iraqi Incident Hemodialysis Patients' Sleep Quality, 2024: A Randomize Controlled Trial

Protocol summary

Study aim
1- To investigate effect of Benson's Relaxation Technique on Incident Hemodialysis Patients' Sleep Quality. 2. To determine differences between effect of Benson's Relaxation Technique on incident hemodialysis Patients with their sociodemographic variables.
Design
A parallel, Randomized Control Trial design, to determine effect of Benson's Relaxation Technique on Incident Hemodialysis Patients' Sleep Quality.
Settings and conduct
Al-Hussien Teaching Hospital and Al-Nasiriyah Teaching Hospital in Hemodialysis Units.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who undergoing hemodialysis, agree to share in the study. who are From 27 years old , at the time of the data collection phase Exclusion criteria: Involvement with any other ongoing studies. Medically diagnosed with psycho-mental diseases. patients who were diagnosed with unstable hypertension, arrhythmia, cardiac angina, congestive heart failure, acute cerebrovascular accident, or hepatic failure throughout the study were excluded from the study. The presence of physical restrictions that delayed learning before or during the relaxation therapy.
Intervention groups
Firstly, After the initial assessment using the Pittsburgh Sleep Quality Index (PSQI), for participants, that receive the Benson's Relaxation Technique (PRT) (Herbert,1975). The technique involves step-by-step guidance through deep breathing exercises, muscle relaxation. The intervention is administered by researchers according to established protocols, ensuring consistency and adherence to the technique. Following the intervention, the researcher reassesses sleep quality using the PSQI at designated time points, specifically after four weeks. Participants in the intervention group will be asked to complete the PSQI.
Main outcome variables
Promoting (improvement) Patients' Sleep quality

General information

Reason for update
Acronym
A Randomized controlled trial (ARCT)
IRCT registration information
IRCT registration number: IRCT20230310057672N4
Registration date: 2024-04-11, 1403/01/23
Registration timing: prospective

Last update: 2024-04-11, 1403/01/23
Update count: 0
Registration date
2024-04-11, 1403/01/23
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
Recruitment complete
Funding source
Expected recruitment start date
2024-04-15, 1403/01/27
Expected recruitment end date
2024-05-16, 1403/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study to Investigate Effect of Benson's Relaxation Technique on Iraqi Incident Hemodialysis Patients' Sleep Quality, 2024: A Randomize Controlled Trial
Public title
Study to Investigate Effect of Benson's Relaxation Technique on Iraqi Incident Hemodialysis Patients' Sleep Quality, 2024
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergoing hemodialysis, agree to share in the study. who are from 27 years old, had undergone hemodialysis (HD) at least twice a week for a duration of 3-6 months only. Patients were mentally attentive and oriented, literate, at the time of the data collection phase
Exclusion criteria:
Involvement with any other ongoing studies. the exclusion criteria patients who were diagnosed with unstable hypertension, arrhythmia, cardiac angina, congestive heart failure, acute cerebrovascular accident, or hepatic failure throughout the study were excluded from the study. The presence of physical restrictions that delayed learning before or during the relaxation therapy was one of the exclusion criteria. The study excluded participants who had emotional distress in the previous month.
Age
From 27 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 71
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will be implemented using a simple random method facilitated by a dice to each participant has an equal chance of being assigned to any group , The assignment of participants to either the intervention group or the control group will be determined. Each participant will be assigned a unique identification number. The dice will be rolled for each participant, with an even number indicating assignment to the intervention group and an odd number indicating assignment to the control group. Specifically, a standard six-sided dice will be used. If the dice roll results in an even number (2, 4, or 6), the participant will be allocated to the intervention group. Conversely, if the dice roll results in an odd number (1, 3, or 5), the participant will be allocated to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
To achieve single blind in this trial, participants will be kept blinded to their group assignment (Benson's Relaxation Technique intervention or control group) throughout the study. The assigned intervention group will receive the Benson's Relaxation Technique, while the control group will receive standard care, without disclosing the participant's group assignment. The researchers and data collectors will have knowledge of group allocation to ensure single-blinding. The interventions will be randomized, and the assessment of sleep quality will be conducted without revealing the type of intervention received by participants, ensuring that their expectations do not influence the results. These rigorous procedures minimize the impact of prior expectations and guarantee the integrity of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing and Central Statistical Organization,
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10045
Approval date
2023-05-11, 1402/02/21
Ethics committee reference number
3684 /8/1/3/1

Health conditions studied

1

Description of health condition studied
sleep disorder
ICD-10 code
F51.8
ICD-10 code description
Other sleep disorders not due to a substance or known physiological condition

2

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
The primary outcome variable to improvement and promoting sleep of patients with hemodialysis (Quality of Sleep)
Timepoint
After implementing the clinical trial intervention for approximately 30 days of applying the Benson relaxation technique to hemodialysis patients, the results of the intervention for sleep in dialysis patients (sleep quality) for both groups appear. Sleep quality will be evaluated after one month
Method of measurement
Measurement method before and after clinical intervention using "The Pittsburgh Sleep Quality Index (PSQI)" is a self-report survey to evaluate the quality of sleep and disruptions experienced within a period of one month. and takes 5–10 minutes to complete (Buysse DJ, et al, 1989).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the initial assessment using The Pittsburgh Sleep Quality Index (PSQI), participants in the intervention group receive the Benson's Relaxation Technique (BRT) intervention. The Benson's Relaxation Technique involves step-by-step guidance through deep breathing exercises, muscle relaxation, and focused attention to induce relaxation and promote better sleep quality. The intervention is administered by researchers according to established protocols, ensuring consistency and adherence to the technique. Following the intervention, the researcher reassesses sleep quality using the PSQI at designated time points, specifically after four weeks. The PSQI is a validated questionnaire that evaluates sleep quality over the past month, capturing information on sleep duration, latency, disturbances, efficiency, and overall sleep quality. Participants in the intervention group will be asked to complete the PSQI questionnaire again after four weeks to assess any changes in sleep quality resulting from the Benson's Relaxation Technique intervention.
Category
Treatment - Other

2

Description
Control group: The control group did not receive Benson’s relaxation technique. Instead, they were only subjected to the standard treatment and care. Participants that will assign as control group that exposure to pretest was initially conducted by the Pittsburgh Sleep Quality Index (PSQI), So After a period of four weeks, the participants were also measured for the quality of sleep at the post-test.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Hussien Teaching Hospital Hemodialysis Unit and Al-Nasiriyah Teaching Hospital in Hemodialysis Un
Full name of responsible person
Alaa Jawad Kadhim
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
authors
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
College of Baghdad/ University of Baghdad
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Faculty Member at Adult Nursing Department
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://orcid.org/my-orcid?orcid=0000-0002-4306-6830

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
Faculty Member (Adult Nursing Department)
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
0964-7703520314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://orcid.org/my-orcid?orcid=0000-0002-4306-6830

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
Faculty Member (Adult Nursing Department)
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
0964-7703520314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://orcid.org/my-orcid?orcid=0000-0002-4306-6830

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 six months after the publications, after you are approved to register on the Iranian clinical trials link
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 authors. e-Mail: alaaj@conursing.uobaghdad.edu.iq. amermuhssen@stu.edu.iq
What processes are involved for a request to access data/document
N/A
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.
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