Impact Of Mindfulness Meditation On Pain, Quality Of Sleep, Self-Esteem

NCT06064994 | Completed

• 1 other identifier: 48-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ESRD

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients with ESRD receiving mindfulness meditation

Behavioral: Mindfulness meditation

Control group

NO INTERVENTION

Patients with ESRD receiving traditional care.

Interventions

Mindfulness meditation BEHAVIORAL

The experimental group received the Smith's version of the mindfulness meditation (Smith, 2005), which is a standardized theory-based intervention found to be effective in improving the different dimensions of health. The Smith's version of the mindfulness meditation (Smith, 2005), includes the following components: 1. Being mindful of breathing (5 minutes). 2. Being mindful of the body (5 minutes). 3. Being mindful of thought (5 minutes). 4. Being mindful of sounds (5 minutes). 5. Being mindful of taste (5 minutes) 6. Full meditation

Also known as: Mindfulness-based intervention

Experimental Group

Eligibility Criteria

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

You may qualify if:

• ESRD patient receiving hemodialysis three times per week,
• being at least 18 years old,
• being able to read and write Arabic.

You may not qualify if:

• Patients with cognitive dysfunction or mental retardation,
• those who regularly used psychopharmacological, pain or sleeping pills,
• or received psychotherapy

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, None Selected, 22110, Jordan

Location

Related Publications (22)

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• Alghadir AH, Anwer S, Iqbal ZA. The psychometric properties of an Arabic numeric pain rating scale for measuring osteoarthritis knee pain. Disabil Rehabil. 2016 Dec;38(24):2392-7. doi: 10.3109/09638288.2015.1129441. Epub 2016 Jan 6.

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MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hossam Alhawatmeh

  Hossam alhawatmeh, associate professor, Jordan university of science and technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant, who was not involved in any other aspects of the study and was blinded to the randomized allocation, measured the study variables at three points of time
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: An experimental randomized repeated-measures, parallel control design

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: April 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)