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The Impact of Mindfulness-Based Intervention on Psychophysical Health

NCT06064708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-05-06

No results posted yet for this study

Summary

Background: Hemodialysis is considered as an effective therapy to remove harmful wastes from the body and to improve the quality of life in patients suffering from end-stage renal disease (ESRD). However, patients who receive hemodialysis perceive various stressors that are harmful to their physical and psychological well-being, particularly the immune system. Therefore, it is necessary to implement effective and practical therapeutic strategies to enhance the quality of life in this population. Mindfulness-based intervention is an effective mind-body connection program that is inadequately used in patients undergoing hemodialysis.

Objective: The current study aimed to investigate the effect of mindfulness-based intervention on physical and psychological symptoms (e.g., stress, anxiety, and depression) and pro-inflammatory biomarker levels (e.g., TNF, interleukin-6, and C-reactive protein) in patients with ESRD undergoing hemodialysis.

Method: Repeated measures, randomized, control experimental design was used. A convenience non-probability sampling technique to select the sample from the hemodialysis unit in the Princess Haya Bint AL\_Hussine Hospital. The participants who were eligible and agreed to participate were randomly distributed into experimental (n = 31) and control (n = 30) groups. During their hemodialysis sessions, the experimental group' participants practiced 30-minute mindfulness-based intervention; three times a week for eight weeks). The Mindful Attention Awareness Scale (MAAS), Depression, Anxiety, and Stress Scale - 21 (DASS-21), Patient Health Questionnaire (PHQ-15), and serum blood levels (for tumor necrosis factor, interleukin-6, and C-reactive protein) were used to measure the dependent variables for both groups at baseline, after five weeks of the intervention, and at its end (eight weeks).

Conditions

Interventions

BEHAVIORAL

Mindfulness-based intervention

The experimental group received 30 minutes of MBI according to Smith's (2005) MBI protocol, which is a standardized theory-based intervention. Smith's (2005) MBI protocol comprises six components: 1. Being mindful of the breath (5 minutes). 2. Being mindful of the body (5 minutes). 3. Being mindful of the thought (5 minutes) 4. Being mindful of the sound (5 minutes) 5. Being mindful during walking (5 minutes) 6. Full meditation (5 minutes).

Sponsors & Collaborators

  • Jordan University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2023-08-10
Completion
2023-08-30

Countries

  • Jordan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06064708 on ClinicalTrials.gov