Effectiveness of 20m-MB in KTR Symptom Control

NCT05809440 | Completed

• 1 other identifier: 2020116-9206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transplant;Failure,Kidney

Keywords

transplant; mindfulness; mindful breathing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute

  20 minutes

• Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores

  20 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

No intervention was provided for control group.

Interventions

20-minute mindful breathing session 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult renal transplant patients aged 18 years and older
• At least one symptom scoring ≥ 4/10 based on the Edmonton Symptom Assessment Scale (ESAS)

You may not qualify if:

• Dialysis-dependent
• Medically unstable
• Having serious pre-existing mental health issues

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Related Publications (4)

• 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.

  PMID: 22578312 RESULT

• 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.

  PMID: 19153131 RESULT

• 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.

  PMID: 34597266 RESULT

• 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.

  PMID: 31898113 RESULT

Study Officials

• Seng Beng Tan, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Kok Peng Ng

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: April 12, 2023
• Study Start: November 1, 2020
• Primary Completion: May 20, 2021
• Study Completion: November 30, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)