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Trial registered on ANZCTR


Registration number
ACTRN12621001297819
Ethics application status
Approved
Date submitted
11/05/2020
Date registered
24/09/2021
Date last updated
24/09/2021
Date data sharing statement initially provided
24/09/2021
Date results provided
24/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Efficacy of 20-Minute Mindful Breathing on the Dialysis Recovery Time (DRT) of Haemodialysis Patients: A Randomized Controlled Trial
Scientific title
The Efficacy of 20-Minute Mindful Breathing on the Dialysis Recovery Time (DRT) of Haemodialysis Patients: A Randomized Controlled Trial
Secondary ID [1] 301230 0
None
Universal Trial Number (UTN)
Trial acronym
MiBDRT
Linked study record
Not relevant

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 317392 0
Condition category
Condition code
Renal and Urogenital 315495 315495 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 20-minute mindful breathing session guided by a trained research assistant in mindfulness. The session includes instructing participants to relax their body, close their eyes and focus all their attention on their breathing. If they are distracted by anything such as sounds, body sensations, thoughts, or feelings, they will be told to redirect their attention back to their breathing. The participants in the intervention group will be required to complete at least 6 sessions of 20-minute mindful breathing during dialysis treatment within 2 weeks. Attendance check-list will be used to assess the adherence to the sessions.
Intervention code [1] 317532 0
Lifestyle
Comparator / control treatment
The participants in the control group will receive "standard of care" during hemodialysis session. "Standard of care" during hemodialysis means patients will be allowed to do the usual activities they do during a dialysis session, without specific instructions from study team.
Control group
Active

Outcomes
Primary outcome [1] 323735 0
Difference in Dialysis recovery time (DRT) between baseline and 2 weeks after completion of intervention. DRT was determined by asking participants the following question: “How long does it take you to recover from a dialysis session?” This question is now recognized as a validated tool giving insight into patients’ subjective experience of dialysis. For standardization purpose, the DRT assessment was done between 2nd hour to 3rd hour of their 4 hours dialysis session. Each DRT reflected the recovery time of the previous hemodialysis (HD) session.
Timepoint [1] 323735 0
2 weeks
Secondary outcome [1] 382757 0
Difference in sleep quality between baseline and 2 weeks after completion of intervention. Sleep quality was assessed with the Pittsburgh Sleep Quality Index (PSQI) at T0 and T6. PSQI is a validated self-rated questionnaire which assesses sleep quality and disturbances.
Timepoint [1] 382757 0
2 weeks
Secondary outcome [2] 382758 0
Difference in health related quality of life (QOL) between baseline and 2 weeks after completion of intervention. Health related quality of life was measured with EQ-5D at T0 and T6. EQ-5D is a validated quality of life instrument that consists of the EQ-5D descriptive system that measures the five dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-VAS that measures the overall health status with a visual analogue scale marked from 0 (worst imaginable health state) to 100 (best imaginable health state).
Timepoint [2] 382758 0
2 weeks

Eligibility
Key inclusion criteria
(1) End Stage Kidney Disease undergoing haemodialysis (HD) 3 sessions per week
(2) ESKD undergoing HD treatment for more than 3 months
(3) Patients with Dialysis Rocovery Time of more than 2 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patients with delirium or confusion
(2) Patients who decline to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were randomly assigned to the intervention group or the control group based on computer generated random numbers, with a 1:1 allocation ratio. Allocation concealment was performed by concealing the random numbers in sequentially numbered sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use a randomisation table created by computer software (i.e. computerised sequence
generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A planned sample size of 60 patients (30 per arm) was powered to detect the effect size difference between the two study arms of 0.8 standard deviation units (i.e. change of 160min on the DRT), with a two-tailed type I error rate of 0.05, 80% power and 15% dropout rate.

For descriptive statistics; normally distributed data will be presented by the mean and standard deviation (SD) and skewed distributions by the median and interquartile range (IQR).

The primary analysis will compare intervention groups (mindful breathing + standard of care) to control group (placebo + standard of care) on the change in Dialysis Recovery Time (DRT) between baseline and post-intervention (2 weeks) using a linear mixed model. Difference in DRT from baseline to post-intervention will be the dependent variable. Study subjects will be considered as random effects and treatment group as fixed effects. The estimated difference in DRT from baseline to 2 weeks (post-intervention) and the corresponding 95 % confidence interval (CI) will be presented.

The secondary analysis on difference in sleep quality and health related quality of life (QOL) will be analysed using the same method as for the primary outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/01/2019
Date of last participant enrolment
Anticipated
Actual
24/06/2019
Date of last data collection
Anticipated
Actual
24/07/2019
Sample size
Target
60
Accrual to date
Final
62
Recruitment outside Australia
Country [1] 22537 0
Malaysia
State/province [1] 22537 0

Funding & Sponsors
Funding source category [1] 305680 0
Self funded/Unfunded
Name [1] 305680 0
Unfunded
Country [1] 305680 0
Primary sponsor type
Individual
Name
Lim Soo Kun
Address
Renal Division, Department of Medicine
University Malaya Medical Centre
59100 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 309559 0
None
Name [1] 309559 0
None
Address [1] 309559 0
None
Country [1] 309559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305960 0
UNIVERSITY MALAYA MEDICAL CENTRE ETHIC COMMITTEE
Ethics committee address [1] 305960 0
Ethics committee country [1] 305960 0
Malaysia
Date submitted for ethics approval [1] 305960 0
29/10/2018
Approval date [1] 305960 0
23/01/2019
Ethics approval number [1] 305960 0
20181029-6810

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102218 0
A/Prof Lim Soo Kun
Address 102218 0
Renal Division, Department of Medicine
University Malaya Medical Centre
50603, Kuala Lumpur
Malaysia
Country 102218 0
Malaysia
Phone 102218 0
+60124675199
Fax 102218 0
Email 102218 0
limsk@ummc.edu.my
Contact person for public queries
Name 102219 0
Lim Soo Kun
Address 102219 0
Renal Division, Department of Medicine
University Malaya Medical Centre
50603, Kuala Lumpur
Malaysia
Country 102219 0
Malaysia
Phone 102219 0
+60124675199
Fax 102219 0
Email 102219 0
limsk@ummc.edu.my
Contact person for scientific queries
Name 102220 0
Lim Soo Kun
Address 102220 0
Renal Division, Department of Medicine
University Malaya Medical Centre
50603, Kuala Lumpur
Malaysia
Country 102220 0
Malaysia
Phone 102220 0
+60124675199
Fax 102220 0
Email 102220 0
limsk@ummc.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses,
How or where can data be obtained?
Approach Corespondring Investigator (Dr. Lim Soo Kun, limsk@ummc.edu.my)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7912Study protocol  limsk@ummc.edu.my 379790-(Uploaded-11-05-2020-02-15-33)-Study-related document.pdf
7913Informed consent form    379790-(Uploaded-11-05-2020-02-20-17)-Study-related document.pdf
7914Ethical approval    379790-(Uploaded-25-05-2021-01-21-23)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.