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The Impact of Mindfulness-Based Intervention on Pro-Inflammatory Cytokines - Trial NCT06064708

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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NCT06064708
Completed
behavioral
Trial Details
ClinicalTrials.gov โ€ข NCT06064708
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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

Study Focus

End Stage Renal Disease

Mindfulness-based intervention

Interventional

behavioral

Sponsor & Location

Jordan University of Science and Technology

Irbid,Irbid, Jordan

Timeline & Enrollment

N/A

Apr 10, 2023

Aug 30, 2023

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 1
Chronic kidney disease, stage 5
Chronic kidney disease, stage 2
Chronic kidney disease, stage 3
Chronic kidney disease, stage 4

Data Source

ClinicalTrials.gov

NCT06064708

Non-Device Trial