Effectiveness of 20m-MB in KTR Symptom Control

NCT ID: NCT05809440

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-11-30

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.

Conditions

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Transplant;Failure,Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

20-minute mindful breathing session

Intervention Type OTHER

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.

Control Group

No intervention was provided for control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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A/Prof. Dr. Ng Kok Peng

Consultant Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seng Beng Tan, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Kok Peng Ng

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University of Malaya Medical Center

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type RESULT
PMID: 22578312 (View on PubMed)

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.

Reference Type RESULT
PMID: 19153131 (View on PubMed)

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.

Reference Type RESULT
PMID: 34597266 (View on PubMed)

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.

Reference Type RESULT
PMID: 31898113 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020116-9206

Identifier Type: -

Identifier Source: org_study_id

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