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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]

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

Condition category

Condition code

Renal and Urogenital

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]

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]

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]

2 weeks

Secondary outcome [1]

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]

2 weeks

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

Unfunded

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNIVERSITY MALAYA MEDICAL CENTRE ETHIC COMMITTEE

Ethics committee address [1]

UNIVERSITY MALAYA MEDICAL CENTRE
JALAN UNIVERSITI
50603 KUALA LUMPUR, MALAYSIA

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

29/10/2018

Approval date [1]

23/01/2019

Ethics approval number [1]

20181029-6810

Summary

Brief summary

This is a non-blinded and randomized controlled study which studied the effect of mindful breathing on hemodialysis patients, as compared to standard of care. The effects studied were from 3 aspects, i.e. Dialysis Recovery Time, sleep quality and health-related quality of life. The mindful breathing intervention was carried out for 2 weeks, during the 6 hemodialysis sessions. The effects were compared before and after the intervention, between the mindful breathing group and control group.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Lim Soo Kun

Address

Renal Division, Department of Medicine University Malaya Medical Centre 50603, Kuala Lumpur Malaysia

Country

Malaysia

Phone

+60124675199

Fax

[email protected]

Contact person for public queries

Name

Lim Soo Kun

Address

Renal Division, Department of Medicine University Malaya Medical Centre 50603, Kuala Lumpur Malaysia

Country

Malaysia

Phone

+60124675199

Fax

[email protected]

Contact person for scientific queries

Name

Lim Soo Kun

Address

Renal Division, Department of Medicine University Malaya Medical Centre 50603, Kuala Lumpur Malaysia

Country

Malaysia

Phone

+60124675199

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor.

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?

• For IPD meta-analyses,

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Approach Corespondring Investigator (Dr. Lim Soo Kun, [email protected])

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
7912	Study protocol	[email protected]	Study-related document.pdf
7913	Informed consent form		Study-related document.pdf
7914	Ethical approval		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.

Trial Review

Documents added manually

Documents added automatically