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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04102969
Other study ID # JKEUPM-2019-340
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date June 30, 2020

Study information

Verified date December 2019
Source Universiti Putra Malaysia
Contact Haya Abu-Maloh, PhD Student
Phone 0060173371864
Email yousha_91@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Benson Relaxation Technique
Benson relaxation technique will be performed two times a day for 10 minutes during the study period ( two months) for the intervention group.
Other:
Nutrition Package Session
A nutrition package session will be given to the control group.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universiti Putra Malaysia

References & Publications (3)

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. — View Citation

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. — View Citation

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: 10.101 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
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