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Completed

NCT Number: NCT05809440

Effectiveness of 20m-MB in KTR Symptom Control

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

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Key information

Conditions

Transplant;Failure,Kidney

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute

    Time frame: 20 minutes

    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 outcomes

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

    Time frame: 20 minutes

    Statistical anaylsis done using paired t-tests.

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

    Time frame: 20 minutes

    Statistical anaylsis done using independent sample t-tests

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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