Effectiveness of 20m-MB in KTR Symptom Control

Study Overview
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Brief Summary
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To study the effectiveness of single session 20-minute mindful breathing in symptom control in kidney transplant recipients.

Detailed Description
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Patients undergoing kidney transplant follow ups in our center are screened based on recruitment criteria. Patients who fulfilled the incusion criteria are recruited. Intervention involves a 20-minute mindful breathing session with uniform script performed by trained personal, while control arm involves standard care without intervention.

Official Title
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The Effectiveness of Single Session 20-minute Mindful Breathing in Symptom Control in Kidney Transplant Recipients: a Randomised Controlled Trial

Conditions
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Transplant;Failure,Kidney

Intervention / Treatment
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* Other: 20-minute mindful breathing session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult renal transplant patients aged 18 years and older At least one symptom scoring ≥ 4/10 based on the Edmonton Symptom Assessment Scale (ESAS) Exclusion Criteria: Dialysis-dependent Medically unstable Having serious pre-existing mental health issues

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a parallel-group, non-blinded, randomized controlled trial conducted at the University of Malaya Medical Centre, Malaysia. Patients were recruited from the transplant clinic, the renal day care unit and the nephrology ward. Participants were randomly assigned to either intervention or control based on computer generated random number with 1:1 allocation ratio. Allocations were concealed with sealed envelopes.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>A 20-minute mindful breathing session guided by a trained medical doctor. The session consisted of four 5-minute breathing exercises done consecutively. Participants were instructed to close their eyes and bring their attention to their breathing, and re-direct their attention back to their breathing once they were distracted. | Other: 20-minute mindful breathing session<br>* A 20-minute mindful breathing session guided by a trained medical doctor. The session consisted of four 5-minute breathing exercises done consecutively. Participants were instructed to close their eyes and bring their attention to their breathing, and re-direct their attention back to their breathing once they were distracted.<br>|
| No Intervention: Control Group<br>No intervention was provided for control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute | ESAS is a validated scale to assess 10 symptoms commonly experienced by patients, which are: pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, anorexia, other symptoms, and feelings of well-being. The severity of each symptom was rated on a numerical scale of 0 to 10 (0 = no symptom; 10 = worst possible symptom). | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute | Statistical anaylsis done using paired t-tests. | 20 minutes | 
| Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores | Statistical anaylsis done using independent sample t-tests | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplant, mindfulness, mindful breathing