Clinical trial NCT05809440: 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
Overall status: COMPLETED
Phase: NA
Conditions: Transplant;Failure,Kidney
Keywords: transplant
mindfulness
mindful breathing
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
timeFrame: 20 minutes
Secondary outcomes:
measure: Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
timeFrame: 20 minutes
measure: Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Center
Study officials:
affiliation: University of Malaya
name: Seng Beng Tan, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Kok Peng Ng
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.