Benson Relaxation Technique on Perceived Stress and Pain Among Hemodialysis Patients

NCT04102969 | Unknown

• 1 other identifier: JKEUPM-2019-340
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the effectiveness of Benson relaxation technique on perceived stress and pain among hemodialysis patients at governmental hospitals in Amman, Jordan. Half of the participants the intervention group will receive the intervention of Benson relaxation technique, while the other half the control group will receive a nutrition package session.

Conditions

Relaxation

Keywords

Benson relaxation; Benson response; Relaxation response

Outcome Measures

Primary Outcomes (2)

• The change of Pain level at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.

  Pain is the feeling of unpleasant sensory and discomfort which is experienced by hemodialysis patients. Pain will be measured by scores on the short form McGill Pain Questionnaire (SF-MPQ). The short form McGill Pain Questionnaire (SF-MPQ) consists of three parts: * The first part: consists of 15 descriptive adjectives, 11 sensory and four affective, which are rated on a four point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), yielding three scores. * The second part: Visual Analogue Scale (VAS), which is a 10-centimeter horizontal line from 0 to 10 ranging from "no pain" to the "worst possible pain". * The third part: Present Pain Intensity (PPI), which is a six-point verbal rating scale on rating scale from 0 to 5, the words are: no pain (0), mild pain (1), discomforting (2), distressing (3), horrible (4), and excruciating (5).

  at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.

• The change of Perceived Stress Level at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.

  Perceived stress refers to an undesired state of feeling frustrated, anger and nervous of anxious, which is experienced by hemodialysis patients. The level of stress for the hemodialysis patients will be assessed using the Perceived Stress Scale. The perceived stress scale (PSS-10) has 10 items on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often). Four positively stated items (item 4, 5, 7, and 8) are reversely scored (0 = very often, 1 = fairy often, 2 = sometimes, 3 = almost never, 4 = never). The sum of the 10 items represents the total score, with higher scores representing higher levels of perceived stress. Individual scores on the Perceived stress score (PSS-10) can range from 0 to 40 with higher scores indicating higher perceived stress.

  at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention.

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group will be instructed by an interventionist who is qualified in stress management and relaxation will perform the Benson relaxation technique to the intervention group to perform the Benson relaxation technique two times a day for 10 minutes during the study period ( two months). Training session of the technique will be repeated if necessary over one or two sessions until the interventionist confirm that the participants acquired sufficient skills. A total of two hours will be scheduled for each session and will be coordinated with the nursing manager of the hemodialysis department.

Behavioral: Benson Relaxation Technique

Control Group

OTHER

A qualified nutritionist will run out a nutrition package session for hemodialysis patients in the control group. This nutrition package session will be for one session for one hour.

Other: Nutrition Package Session

Interventions

Benson Relaxation Technique BEHAVIORAL

Benson relaxation technique will be performed two times a day for 10 minutes during the study period ( two months) for the intervention group.

Intervention group

Nutrition Package Session OTHER

A nutrition package session will be given to the control group.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemodialysis patients who agree to participate in the study (by consent form).
• Hemodialysis patients begin alert, conscious, and oriented.
• Hemodialysis patients able to read and write in Arabic.
• Haemodialysis patients aged 18 years and above, participants of this age and above are adults and able to understand the items in the questionnaires in order to be able to answer them.
• Haemodialysis patients being on haemodialysis for at least six months and currently receiving haemodialysis at a minimum of two times per week. By 6 months, the routine for the hemodialysis procedure is established, and two times per week is the minimum number for dialysis sessions.

You may not qualify if:

• Hemodialysis patients with physical disability and physical limitation for learning and performing the Benson relaxation technique.
• Peritoneal dialysis or a kidney transplant patients.
• Patients who are taking antidepressants medication.
• Haemodialysis patients with cognitive impairment or mental health issues.
• Hemodialysis patients that face crisis intervention including changes in disease progress or loss of consciousness.
• No co-morbidity with other chronic disease like cancer, heart disease, etc. Diabetes and hypertension are included, because usually these co-morbidities are a part of renal failure; excluding them leads to limitation in generalization.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Related Publications (4)

• Mahdavi A, Gorji MA, Gorji AM, Yazdani J, Ardebil MD. Implementing Benson's Relaxation Training in Hemodialysis Patients: Changes in Perceived Stress, Anxiety, and Depression. N Am J Med Sci. 2013 Sep;5(9):536-40. doi: 10.4103/1947-2714.118917.

  PMID: 24251271 RESULT

• Heidari Gorji MA, Davanloo AA, Heidarigorji AM. The efficacy of relaxation training on stress, anxiety, and pain perception in hemodialysis patients. Indian J Nephrol. 2014 Nov;24(6):356-61. doi: 10.4103/0971-4065.132998.

  PMID: 25484528 RESULT

• Rambod M, Sharif F, Pourali-Mohammadi N, Pasyar N, Rafii F. Evaluation of the effect of Benson's relaxation technique on pain and quality of life of haemodialysis patients: a randomized controlled trial. Int J Nurs Stud. 2014 Jul;51(7):964-73. doi: 10.1016/j.ijnurstu.2013.11.004. Epub 2013 Nov 25.

  PMID: 24332569 RESULT

• Abu Maloh HIA, Soh KL, Chong SC, Ismail SIF, Soh KG, Abu Maloh DI, Al Yateem N, AbuRuz ME. The Effectiveness of Benson's Relaxation Technique on Pain and Perceived Stress Among Patients Undergoing Hemodialysis: A Double-Blind, Cluster-Randomized, Active Control Clinical Trial. Clin Nurs Res. 2023 Feb;32(2):288-297. doi: 10.1177/10547738221112759. Epub 2022 Aug 1.

  PMID: 35915917 DERIVED

Related Links

• Study aimed to evaluate the effect of Benson's Relaxation on depression, anxiety and stress in patients undergoing hemodialysis.

Study Officials

• Kim Lam Soh, PhD

  Associate Professor at Department of Nursing and Rehabilitation at UPM

  STUDY DIRECTOR

Central Study Contacts

Haya Abu-Maloh, PhD Student

CONTACT

0060173371864; yousha_91@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinding will be used in this study, by not telling the participants, interventionist, and research assistants what the researcher is looking for to study, what the research outcomes are, and by making them not aware who is receiving the intervention or in which group they are in control or intervention group. So, the participants, interventionist, and research assistants who are in the study will be less likely to inadvertently bias the result.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Nursing Student

Model Details: A cluster randomized controlled trial design (RCT) with two conditions (experimental versus control group) and four repeated measures time points for this study; at baseline test (before intervention), a post-test (immediately after the intervention), and follow up at one month post-intervention, and follow up at two months' post-intervention. Two hospitals will be divided in to Experimental and control hospital. participants in the experimental hospital will receive the intervention of Benson Relaxation technique (Intervention group). participants in the control hospital will receive the nutrition package session (control group).

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 25, 2019
• Study Start: February 1, 2020
• Primary Completion: February 14, 2020
• Study Completion: June 30, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available within 6-8 months of study completion.
• Access Criteria: Access criteria has not been decided yet.