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NCT06064708Completed

The Impact of Mindfulness-Based Intervention on Pro-Inflammatory Cytokines

The Impact of Mindfulness-Based Intervention on Psychosomatic Symptoms and Pro-Inflammatory Cytokines in Patients Undergoing Hemodialysis: An Experimental Study
Jordan University of Science and TechnologyClinicalTrials.govbehavioral
Study focus
Drug/Device/Intervention
Mindfulness-based intervention
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Jordan University of Science and Technology
Location
Irbid,Irbid, Jordan
Timeline & enrollment
Phase
N/A
Start date
Apr 10, 2023
End date
Aug 30, 2023
Enrollment
64 participants
Primary outcome

C-reactive protein,Interleukin 6,Tumor necrosis factor-alpha,Trait mindfulness,Emotional symptoms,Physical symptoms

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).

ICD-10 classifications
Chronic kidney disease, stage 1Chronic kidney disease, stage 5Chronic kidney disease, stage 2Chronic kidney disease, stage 3Chronic kidney disease, stage 4
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06064708
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06064708 through Pure Global AI's free database. This phase not specified trial is sponsored by Jordan University of Science and Technology and is currently Completed. The study focuses on End Stage Renal Disease. Target enrollment is 64 participants.

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