Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000393651
Ethics application status
Approved
Date submitted
30/03/2023
Date registered
18/04/2023
Date last updated
15/09/2023
Date data sharing statement initially provided
18/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth-based group breathing intervention for adults with chronic pain: A randomized controlled trial.
Scientific title
Efficacy of a telehealth-based group breathing intervention on depression, anxiety and stress in patients with chronic pain: a randomized clinical trial
Secondary ID [1] 309299 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 329471 0
Condition category
Condition code
Musculoskeletal 326410 326410 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 326413 326413 0 0
Speech therapy
Anaesthesiology 326596 326596 0 0
Pain management
Mental Health 326597 326597 0 0
Depression
Mental Health 326598 326598 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The telehealth breathing training group consists of 6 sessions over an 8-week period delivered via ZOOM or PEXIP (videoconferencing platform for NSW Health). Each breathing intervention group will have a minimum of 4 participants and no more than 8 participants to ensure individualised feedback is provided. All breathing intervention groups will receive the same intervention program. Each session will be co-run by the principal researcher and one of the associate researchers when feasible. Sessions will be 45 to 60 minutes each in duration. The breathing intervention consists of education focusing on the relationship between breathing, chronic pain, and the autonomic nervous system. Breathing intervention will consist of practicing diaphragmatic breathing and exploring a range of breathing patterns. Participants will engage in group breathing practice and receive feedback for their techniques. Home practice materials in the form of written materials will be made available to the patients at the end of each session. These home practice materials about the breathing techniques and patterns discussed will be designed specifically for this study. Participants will be expected to perform home practice at least 5 days a week. The duration will be at the participant's discretion but recommended to be more than 10 minutes each time. Participant's adherence to the intervention will be monitored via the use of session attendance sheet, and discussion about home practice at each session when appropriate.
Intervention code [1] 325735 0
Treatment: Other
Comparator / control treatment
Standard care.

The control group will continue with standardized care, consisting of scheduled appointments with chronic pain services team, primary health care and pharmacological intervention. At the end of the clinical trial, participants will be offered the breathing intervention if it was found to be beneficial. These participants will not be followed up after they start the intervention.
Control group
Active

Outcomes
Primary outcome [1] 334258 0
Depression measured by the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [1] 334258 0
Baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment (primary endpoint), and 6 months post-initiation of treatment.
Primary outcome [2] 334259 0
Anxiety measured by the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [2] 334259 0
Baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment (primary endpoint), and 6 months post-initiation of treatment.
Primary outcome [3] 334260 0
Stress measured by the Depression Anxiety Stress Scale - 21 items (DASS-21)
Timepoint [3] 334260 0
Baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment (primary endpoint), and 6 months post-initiation of treatment.
Secondary outcome [1] 420007 0
Pain measured by with the Brief Pain Inventory
Timepoint [1] 420007 0
Baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment, and 6 months post-initiation of treatment.
Secondary outcome [2] 420008 0
Pain Catastrophising will be measured with the Pain Catastrophizing Scale.
Timepoint [2] 420008 0
Baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment, and 6 months post-initiation of treatment.
Secondary outcome [3] 420009 0
The level of confidence a person has on his or her ability to participate in a range of activities despite their pain will be measured The Pain Self-Efficacy Questionnaire (PSEQ).
Timepoint [3] 420009 0
Baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment, and 6 months post-initiation of treatment.

Eligibility
Key inclusion criteria
• Patients with non-malignant chronic pain for >3 months confirmed by a medical practitioner or chronic pain specialist.
• 18 years or above,
• moderately depression or moderately anxiety on DASS21
• Moderate pain severity defined as an average severity score of 5 or more on the Brief Pain Inventory
• Have access to stable internet connection and electronic device with teleconferencing capabilities or able to travel to Western NSW Health Community Health Centre to access telehealth facilities,
• Sufficient English skills to participate in the group intervention and interview.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals with spinal cord injury,
• Have a history of central nervous system diseases such as stroke, multiple sclerosis,
• Have known cognitive impairment and impaired memory that will preclude participation,
• Individuals who are currently participating in self-management or other intervention that emphasizes on breathing techniques such as yoga, and meditation,
• Have previous exposure to breathing training programs.

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)
Randomization by computer using central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomization will be performed using a random number generator via an Excel spreadsheet. The randomization process will be undertaken by a research team member who will not be involved in the participant recruitment process directly.
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
All quantitative data in this study will be analysed using the Statistical Package for the Social Sciences ver. 28.0 (SPSS Inc., NY, USA). The Shapiro-Wilk test and residual plot assessment will be used to check for normality prior to analyses. Analyses will be carried out on intention-to-treat basis. The reported outcomes for each standardised measure will be reported as the mean and standard deviation through descriptive statistics, or non-parametric equivalent for data that do not meet normality criteria. A mixed model approach will be used to account for the repeated measures and a participant’s baseline values. Between-group differences will be reported as estimated marginal means from Bonferroni-adjusted post-hoc tests. The primary outcome measure is DASS 21 and the secondary outcome measures are BPI, NRS, PSEQ, PCS and MSK-HQ. The differences in each outcome measures between follow-up and pre-intervention will be presented as mean difference and 95% confidence intervals. A parametric test comparing the 3-time points within and between groups will be used. A significant level will be set at p < 0.05 for all tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/06/2023
Actual
2/08/2023
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
28/03/2025
Actual
Sample size
Target
63
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 24355 0
Orange Health Service - Orange
Recruitment postcode(s) [1] 39936 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 313493 0
University
Name [1] 313493 0
University of Newcastle
Country [1] 313493 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315268 0
None
Name [1] 315268 0
Address [1] 315268 0
Country [1] 315268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312680 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 312680 0
7 Commercial Ave, Dubbo NSW 2830
Ethics committee country [1] 312680 0
Australia
Date submitted for ethics approval [1] 312680 0
20/02/2023
Approval date [1] 312680 0
20/03/2023
Ethics approval number [1] 312680 0
2023/ETH00240

Summary
Brief summary
Chronic pain is one of the most common chronic conditions in Australia and the prevalence is on the rise. It is estimated that by 2050, the prevalence of chronic pain will rise to 5.23 million Australians. People with chronic pain suffer not only physically, but also financially and emotionally. One of the eight goals identified by Painaustralia in the National Strategic Action Plan for Pain Management (2021) is for “People living with pain have timely access to consumer-centered best practice pain management including self-management, early intervention strategies and interdisciplinary care and support”. Chronic pain can have a significant impact on mental health and they commonly occur together. Depression and anxiety are the most common comorbidities associated with chronic pain in Australia at 44.6%, followed by osteoarthritis and degenerative arthritis (29.3%) and hypertension(25.1%). Nearly half of the patients with chronic pain presenting for treatment suffer from major depression. Major depression in people with chronic pain often leads to reduced functioning, poorer treatment response, and increased healthcare costs. Breathing intervention is an effective self-management for a range of medical and mental health conditions. To date, there has not been a reported randomized control trial examining the effectiveness of a breathing intervention for adults with a range of chronic pain types.
This research aims to examine the efficacy of telehealth-based group breathing intervention on patient-reported outcomes in patients with chronic pain as compared to usual care. The research question for this trial is “In people living with chronic pain, what is the effect of a telehealth-based group intervention on mood, pain intensity and interference, catastrophising, and self-efficacy compared with no breathing intervention within a 12-month period?”. The hypothesis of this randomised control trial is “telehealth-based group breathing intervention is beneficial for improving patient-reported outcomes in adults living with chronic pain”.
Once consented to participate this research, participants will be randomized to either treatment (telehealth breathing intervention group) or usual care (control group). Patient reported outcomes will be collected at baseline, 4 weeks post-initiation of treatment, 8 weeks post-initiation of treatment, and 6 months post-initiation of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125542 0
Ms Asta Fung
Address 125542 0
Subacute Care Team,
Orange Health Service,
1530 Forest Road,
Orange NSW 2800
Country 125542 0
Australia
Phone 125542 0
+61 26369 7169
Fax 125542 0
Email 125542 0
asta.fung@uon.edu.au
Contact person for public queries
Name 125543 0
Ms Asta Fung
Address 125543 0
Subacute Care Team,
Orange Health Service,
1530 Forest Road,
Orange NSW 2800
Country 125543 0
Australia
Phone 125543 0
+61 26369 7169
Fax 125543 0
Email 125543 0
asta.fung@uon.edu.au
Contact person for scientific queries
Name 125544 0
Ms Asta Fung
Address 125544 0
Subacute Care Team,
Orange Health Service,
1530 Forest Road,
Orange NSW 2800
Country 125544 0
Australia
Phone 125544 0
+61 26369 7169
Fax 125544 0
Email 125544 0
asta.fung@uon.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification individual participant data underlying published results only.
When will data be available (start and end dates)?
Data will be available from the date of publication of the study, no end date.
Available to whom?
Data will be available to other researchers upon request.
Available for what types of analyses?
Data will be available for replication of the report’s analyses.
How or where can data be obtained?
Data will be made available electronically to other researcher by emailing the principal investigator (asta.fung@uon.edu.au).


What supporting documents are/will be available?

No Supporting Document Provided



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.