Transplant;Failure,KidneyNCT05809440
Effectiveness of 20m-MB in KTR Symptom Control
A study testing 20-minute mindful breathing session in people with Transplant;Failure,Kidney, run by University of Malaya at 1 site in Malaysia.
Trial summary
To study the effectiveness of single session 20-minute mindful breathing in symptom control in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant;Failure,Kidney
- What is being tested?
- 20-minute mindful breathing session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult renal transplant patients aged 18 years and older
- At least one symptom scoring ≥ 4/10 based on the Edmonton Symptom Assessment Scale (ESAS)
Who cannot join
- Dialysis-dependent
- Medically unstable
- Having serious pre-existing mental health issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Single Session 20-minute Mindful Breathing in Symptom Control in Kidney Transplant Recipients: a Randomised Controlled Trial
To study the effectiveness of single session 20-minute mindful breathing in symptom control in kidney transplant recipients.
Read the 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.
- Conditions
- Transplant;Failure,Kidney
- Being tested
- 20-minute mindful breathing session
- Keywords
- transplant, mindfulness, mindful breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-minute mindful breathing sessionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: 20-minute mindful breathing session |
| Control Group | No intervention | No intervention was provided for control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 minutes
Secondary outcomes (2)
Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
Statistical anaylsis done using paired t-tests.
Measured: 20 minutes
Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores
Statistical anaylsis done using independent sample t-tests
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Nov 2020
- Primary completion20 May 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A/Prof. Dr. Ng Kok Peng, University of Malaya
- Investigators
- Seng Beng Tan, MBBS, Principal investigator, University of MalayaKok Peng Ng, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809440
- Sponsor's protocol ID
- 2020116-9206
- Status last verified
- Apr 2023
- First submitted
- 25 Sep 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not shared.
Publications
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.
PubMed 22578312Yong 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.
PubMed 19153131Taylor 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.
PubMed 34597266Wang 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.
PubMed 31898113
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Single Session 20-minute Mindful Breathing in Symptom Control in Kidney Transplant Recipients: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05809440
- Acronym / sponsor ID
- 2020116-9206
- Conditions
- Transplant;Failure,Kidney
- Keywords
- transplant, mindfulness, mindful breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: 20-minute mindful breathing sessionA 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. |
| Control Group | No intervention | –No intervention was provided for control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult renal transplant patients aged 18 years and older
- At least one symptom scoring ≥ 4/10 based on the Edmonton Symptom Assessment Scale (ESAS)
Key exclusion criteria (3 listed)
- Dialysis-dependent
- Medically unstable
- Having serious pre-existing mental health issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20-minute mindful breathing sessionA 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. | Other | Intervention Group |
Primary outcome
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).
2 secondary outcomes
Within-group comparison of Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute
Time frame: 20 minutes
Between-group comparison of changes in Edmonton Symptom Assessment Scale (ESAS) scores
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Results publication: PubMed 22578312Afshar 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.
- Results publication: PubMed 19153131Yong 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.
- Results publication: PubMed 34597266Taylor 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.
- Results publication: PubMed 31898113Wang 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.
- Individual participant dataSharing planned: No. Individual participant data are not shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seng Beng Tan, MBBS principal investigator
University of Malaya
Kok Peng Ng principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20-minute mindful breathing session in people with Transplant;Failure,Kidney, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant-rated Edmonton Symptom Assessment Scale (ESAS) scores at 0 minute and 20 minute (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809440, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.