ESRD Clinical Trial
Official title:
The Impact Of Mindfulness Meditation On Pain, Quality Of Sleep, Self-Esteem In Patients With End-Stage Renal Disease Undergoing Hemodialysis In Jordan
NCT number | NCT06064994 |
Other study ID # | 48-2023 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | June 30, 2023 |
Verified date | September 2023 |
Source | Jordan University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Hemodialysis affects patients' lives and is associated with social, occupational, psychological, and societal problems. Mind-body interventions (MBIs), like mindfulness meditation, have been gaining popularity in the health sector. Pain, sleep quality, and self-esteem have all been positively impacted by MBIs in patients with end-stage renal disease (ESRD). Health care providers may be able to provide more thorough care if they are aware of these interventions. Purpose: To assess the impact of mindfulness meditation on pain, quality of sleep, and self-esteem, and self-management in patients with ESRD undergoing hemodialysis in Jordan. Methods: An experimental repeated measure, randomized, parallel control design was conducted on 60 patients with ESRD undergoing hemodialysis between March and June 2023 in the dialysis center at Alkarak governmental hospital, Jordan. Participants were randomly assigned to the experimental (N =30) and control groups (N =30) using a simple random assignment method. The experimental group practiced mindfulness meditation for 30 minutes three times per week for five weeks during their hemodialysis treatments. The control group's patients continued to receive hemodialysis treatment as usual, with three hemodialysis sessions for five weeks without any additional intervention. The study variables for both groups were measured at baseline (T0), two weeks after intervention (T1), and at the end of intervention (T2). Variables were measured by the Numeric Pain Rating Scale (NPRS), the Pittsburgh Sleep Quality Index (PSQI), and the Rosenberg Self-Esteem Scale (RSES-M) questionnaire. Descriptive statistics like frequency, mean, and standard deviation were used to describe participants. The repeated measures ANOVA (within-subject) tests were used to examine the study hypotheses.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ESRD patient receiving hemodialysis three times per week, - being at least 18 years old, - being able to read and write Arabic. Exclusion Criteria: - Patients with cognitive dysfunction or mental retardation, - those who regularly used psychopharmacological, pain or sleeping pills, - or received psychotherapy |
Country | Name | City | State |
---|---|---|---|
Jordan | Jordan University of Science and Technology | Irbid | None Selected |
Lead Sponsor | Collaborator |
---|---|
Jordan University of Science and Technology |
Jordan,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain perception | The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain severity in adults (Child et al.,2005).The NPRS is a segmented numerical version of the visual analog scale (VAS), in which the respondent chooses a number (0-10 integers) that best describes the degree of pain (Rodriguez, 2001). Both literate and illiterate rheumatoid arthritis patients have shown high test-retest reliability (r = 0.96 and 0.95, respectively). For evaluating pain levels in Arabic countries, the Arabic Numeric Pain Rating Scale was a valid and reliable tool.The Arabic Numerical Pain Rating Scale had a high correlation coefficient (r140.93-0.94) with the VAS and VRS, indicating strong consistency in pain level measures among the three pain scales (Alghadir, Anwer, & Iqbal, 2016). | 6 weeks | |
Primary | Quality of sleep | quality of sleep was measured by The Pittsburgh Sleep Quality Index (PSQI) (Buysse, Reynolds, Monk, Berman, and Kupfer, 1989). The PSQI was created to assess the clinical population's sleep quality. Subjective sleep quality (1 item), sleep latency (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (9 items), use of sleeping medication (1 item), and daytime dysfunction (2) are the seven dimensions of sleep characteristics included in the PSQI. The scoring of PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). | 6 weeks | |
Primary | Self-esteem | self-esteem was measured by the Rosenberg self-esteem scale (Rosenberg, 1989). Total score range from 10-40, highest score reveals better self-esteem (Rosenberg, 1979). The Arabic version of the RSES is valid, reliable, and beneficial to use among the Arab community, according to two studies conducted among the Arab population in Jordan and Lebanon (Bezri et al., 2022). | 6 weeks |
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