Effectiveness of 20m-MB in KTR Symptom Control

Transplant;Failure,Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809440
• Other study ID #: 2020116-9206
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2023
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency
• Transplant;Failure,Kidney

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & 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. — View 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):1083-1 — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute	Statistical anaylsis done using paired t-tests.	20 minutes
Secondary	Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores	Statistical anaylsis done using independent sample t-tests	20 minutes