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Effectiveness of 20m-MB in KTR Symptom Control

The Effectiveness of Single Session 20-minute Mindful Breathing in Symptom Control in Kidney Transplant Recipients: a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05809440
Enrollment
60
Registered
2023-04-12
Start date
2020-11-01
Completion date
2021-11-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant;Failure,Kidney

Keywords

transplant, mindfulness, mindful breathing

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.

Interventions

OTHER20-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.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute20 minutesESAS 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

MeasureTime frameDescription
Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute20 minutesStatistical anaylsis done using paired t-tests.
Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores20 minutesStatistical anaylsis done using independent sample t-tests

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026