Effectiveness of 20m-MB in KTR Symptom Control

Not Applicable

Completed

• Conditions: Transplant;Failure,Kidney
• Interventions: Other: 20-minute mindful breathing session

• Registration Number: NCT05809440
• Lead Sponsor: University of Malaya

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-05-20
• Study Completion: 2021-11-30
• Study First Submitted: 2022-09-25
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-09
• Last Update Submitted: 2023-04-09
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	20-minute mindful breathing session	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.

Primary Outcome Measures

Name	Time	Method
Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute	20 minutes	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia