CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Mindfulness-based interventionbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06064708
NCT06064708N/ACompleted

The Impact of Mindfulness-Based Intervention on Psychophysical Health in Patients Undergoing Hemodialysis: An Experimental Study

Jordan University of Science and Technology·interventional·Posted Oct 3, 2023·Updated May 6, 2024

In Brief

A clinical study evaluating Mindfulness-based intervention for End Stage Renal Disease. Completed, enrolled 64 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJordan
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedOct 3, 2023
Enrollment StartApr 10, 2023
Primary CompletionAug 10, 2023
Study CompletionAug 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.7 years ago

Interventions

Mindfulness-based interventionbehavioral

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).