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Effectiveness of 20m-MB in KTR Symptom Control

Primary Purpose

Transplant;Failure,Kidney

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
20-minute mindful breathing session
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Transplant;Failure,Kidney focused on measuring transplant, mindfulness, mindful breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

No intervention was provided for control group.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2022
Last Updated
April 9, 2023
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT05809440
Brief Title
Effectiveness of 20m-MB in KTR Symptom Control
Official Title
The Effectiveness of Single Session 20-minute Mindful Breathing in Symptom Control in Kidney Transplant Recipients: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant;Failure,Kidney
Keywords
transplant, mindfulness, mindful breathing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention was provided for control group.
Intervention Type
Other
Intervention Name(s)
20-minute mindful breathing session
Intervention Description
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 Measure Information:
Title
Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
Description
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).
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
Description
Statistical anaylsis done using paired t-tests.
Time Frame
20 minutes
Title
Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores
Description
Statistical anaylsis done using independent sample t-tests
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seng Beng Tan, MBBS
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kok Peng Ng
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data are not shared.
Citations:
PubMed Identifier
22578312
Citation
Afshar M, Rebollo-Mesa I, Murphy E, Murtagh FE, Mamode N. Symptom burden and associated factors in renal transplant patients in the U.K. J Pain Symptom Manage. 2012 Aug;44(2):229-38. doi: 10.1016/j.jpainsymman.2011.08.005. Epub 2012 May 10.
Results Reference
result
PubMed Identifier
19153131
Citation
Yong DS, Kwok AO, Wong DM, Suen MH, Chen WT, Tse DM. Symptom burden and quality of life in end-stage renal disease: a study of 179 patients on dialysis and palliative care. Palliat Med. 2009 Mar;23(2):111-9. doi: 10.1177/0269216308101099. Epub 2009 Jan 19.
Results Reference
result
PubMed Identifier
34597266
Citation
Taylor K, Chu NM, Chen X, Shi Z, Rosello E, Kunwar S, Butz P, Norman SP, Crews DC, Greenberg KI, Mathur A, Segev DL, Shafi T, McAdams-DeMarco MA. Kidney Disease Symptoms before and after Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Jul;16(7):1083-1093. doi: 10.2215/CJN.19031220. Epub 2021 Jun 18.
Results Reference
result
PubMed Identifier
31898113
Citation
Wang H, Du C, Liu H, Zhang S, Wu S, Fu Y, Zhao J. Exploration of symptom experience in kidney transplant recipients based on symptoms experience model. Qual Life Res. 2020 May;29(5):1281-1290. doi: 10.1007/s11136-019-02404-5. Epub 2020 Jan 2.
Results Reference
result

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Effectiveness of 20m-MB in KTR Symptom Control

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