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
Verified date | April 2023 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To study the effectiveness of single session 20-minute mindful breathing in symptom control in kidney transplant recipients.
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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | University of Malaya Medical Center | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
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
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 |
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