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Trial registered on ANZCTR


Registration number
ACTRN12623000560695
Ethics application status
Approved
Date submitted
28/02/2023
Date registered
24/05/2023
Date last updated
31/05/2024
Date data sharing statement initially provided
24/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindful breathing intervention for breathlessness in Chronic obstructive pulmonary disease
Scientific title
Investigating the effect of an eight-week mindful breathing programme on breathlessness and self-efficacy in Chronic obstructive pulmonary disease: A feasibility study
Secondary ID [1] 297760 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breathlessness 328167 0
Condition category
Condition code
Respiratory 325217 325217 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This mixed methods feasibility study proposes a novel approach to breathlessness management. This study seeks to explore the use of a mindful breathing intervention added to optimal pharmacological and non-pharmacological management already included within usual care (treatment as usual).
The mindful breathing intervention will be delivered by the researcher, who is a Nurse Practitioner with a special interest in respiratory diseases and under the guidance of a supervisor (JJ) with expertise in mindfulness. The intervention is self -managed by the participant in their own home.
At the two/four/and six-week points of the study participants will be contacted by telephone, text or email whichever is their preference. The purpose of this contact is to offer encouragement to continue the daily diary documentation and daily use of the mindful breathing intervention.

At the first meeting with the participants (pre-mindful breathing intervention) the researcher will provide an information pack containing fact sheets on breathlessness including activity pacing and positions to alleviate or reduce breathlessness. In addition, the participants will also be provided with a DVD (or suitable media recording/podcast) on mindfulness to assist breathing and relaxation. There are nine mindfulness sessions to be undertaken one per week for eight weeks. Apart from week six which has two audios, all weeks have only one audio. Audios range from three to 26 minutes in duration.
The participants will be asked to complete a daily diary (electronic or paper) which will be collected by the researcher at the conclusion of the study when the researcher undertakes the second (post) home or clinic visit. The daily diary will collect information on medication/mindfulness use, exercise or physical activity, breathlessness (Medical Research Council [MRC scale]) and social/supportive interactions. The daily diary will also include a free text section to include other ways/techniques which the participant may have used to alleviate breathlessness. The diary may also be a monitoring tool and it is hoped will provide important additional information including concordance with daily mindfulness.
Intervention code [1] 324823 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333060 0
Change in self-efficacy assessed using the COPD Self-Efficacy Scale
.



Timepoint [1] 333060 0
Pre-commencement of the intervention. and nine weeks post-commencement of the intervention.
Primary outcome [2] 334704 0
The feasibility study will assess the efficacy of the recruitment strategy in recruiting potential participants and the required recruitment timeframe by audit of the study records
Timepoint [2] 334704 0
At the three month follow-up point post completion of the intervention
Primary outcome [3] 334705 0
The feasibility study will assess participant adherence to the mindful breathing intervention and daily diary and the usefulness of the proposed data set.
Timepoint [3] 334705 0
At the three month follow-up point post completion of the intervention
all measures will be assessed as a composite primary outcome. This will be measured by audit of the study records and ten qualitative interviews. The interviews will be semi-structured one-on-one face- to-face undertaken by the principal investigator/researcher.
Secondary outcome [1] 415684 0
Change in breathlessness assessed using the Medical Research Council (MRC) Dyspnoea Scale
Timepoint [1] 415684 0
Pre-commencement of the intervention. and nine weeks post-commencement of the intervention. and documented in the daily dairy
Secondary outcome [2] 415685 0

Change in Mindfulness assessed using the 5-facet questionnaire short form .
Timepoint [2] 415685 0
Pre-commencement of the intervention. and nine weeks post-commencement of the intervention.

Eligibility
Key inclusion criteria
Able to provide informed consent
Refractory breathlessness at rest (MRC dyspnoea scale equal to or greater than 2) at any time in the preceding four weeks.
Patients of Te Whata Ora (previously the Canterbury District Health Board [CDHB]) respiratory outpatient service
Aged between 18-90 years
Capable of writing/maintaining a diary
Able to converse, and in English, for at least 60 mins for interviews
Access to a device to play mindfulness recordings (Podcasts/CD’s/USB) (If the participant does not have access to a suitable device, they will be loaned a device for the duration of the study
Anxiety and depression
may be on long term oxygen therapy (LTOT)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Breathlessness of unknown origin including a primary diagnosis of chronic
hyperventilation syndrome.
Within two weeks of an acute exacerbation requiring hospitalisation.
Life expectancy of < 3 months.
• Acute psychiatric disorder including schizophrenia, bipolar disorder, substance use
disorder or suicidality.
Cancer diagnosis; or,
Neurological disease and/or Cognitive Impairment, including dementia.
Residing in the Chatham Islands due to travel logistics for the pre and post intervention
home visits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis has been discussed with a University of Otago Biostatistician
the study aims to recruit 25 -30 participants
Data analyses will be performed using Statistical Package for the Social Sciences (SPSS) (version 27.0: SPSS Inc., Chicago, Il., USA)
Descriptive data will be reported in percentages, mean (standard deviations) and medians (ranges).
Paired t-tests will be used to calculate the pre and post change scores for the self-reported measures. The level of statistical significance will be set at p < .05. however, with the small sample size it is unlikely that there will be statistically significant differences established on the outcome measures however it is envisaged the study will establish effect sizes.
Qualitative interviews will be imported into Nvivo (version 11 and inductive thematic content analysis utilising Braun and Clarke’s (2006) naturalistic interpretive approach employing structured process steps will explore the patient’s own views and experiences of the mindful breathing intervention, this process will incorporate member checking to ensure accuracy of interpretation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/07/2023
Actual
30/07/2023
Date of last participant enrolment
Anticipated
30/10/2023
Actual
19/12/2023
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 25113 0
New Zealand
State/province [1] 25113 0
Canterbury

Funding & Sponsors
Funding source category [1] 302284 0
University
Name [1] 302284 0
University of Otago (Christchurch )
Country [1] 302284 0
New Zealand
Primary sponsor type
University
Name
University of Otago (Christchurch )
Address
Level 3
72 Oxford terrace
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 314227 0
None
Name [1] 314227 0
Address [1] 314227 0
Country [1] 314227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302960 0
Northern B Health and disability Ethics Committee
Ethics committee address [1] 302960 0
Ethics committee country [1] 302960 0
New Zealand
Date submitted for ethics approval [1] 302960 0
30/11/2022
Approval date [1] 302960 0
14/04/2023
Ethics approval number [1] 302960 0
2023 FULL 15152

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

Contacts
Principal investigator
Name 91986 0
Mrs Shirley K A Harris
Address 91986 0
Centre for Postgraduate Nursing (University of Otago - Christchurch)
PO Box 4345, 72 Oxford Terrace
Christchurch
8041
New Zealand
Country 91986 0
New Zealand
Phone 91986 0
+64 0273500529
Fax 91986 0
none
Email 91986 0
shirley.harris@otago.ac.nz
Contact person for public queries
Name 91987 0
Shirley K A Harris
Address 91987 0
Centre for Postgraduate Nursing (University of Otago - Christchurch)
PO Box 4345, 72 Oxford Terrace
Christchurch
8041
New Zealand
Country 91987 0
New Zealand
Phone 91987 0
+64 0273500529
Fax 91987 0
none
Email 91987 0
shirley.harris@otago.ac.nz
Contact person for scientific queries
Name 91988 0
Shirley K A Harris
Address 91988 0
Centre for Postgraduate Nursing (University of Otago - Christchurch)
PO Box 4345, 72 Oxford Terrace
Christchurch
8041
New Zealand
Country 91988 0
New Zealand
Phone 91988 0
+64 0273500529
Fax 91988 0
none
Email 91988 0
shirley.harris@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This research is a PhD project and IPD will not be made available publically
Identifiable information is any data that could identify the participant (e.g., their name, date of birth, or address). Only the research team (SH, JJ, MW, PS) will have access to the identifiable information. To ensure the participants personal information is kept confidential, information that identifies them will not be included in any report generated by the research team. Instead, the participants will be identified by a code. The research team will keep a list linking this code with the participants name so that they can be identified by their coded data if needed.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18147Study protocol  shirley.harris@otago.ac.nz 377232-(Uploaded-28-02-2023-10-00-35)-Study-related document.docx
18148Informed consent form  shirley.harris@otago.ac.nz 377232-(Uploaded-28-02-2023-09-59-07)-Study-related document.doc
19123Ethical approval  shirley.harris@otago.ac.nz 377232-(Uploaded-09-05-2023-12-39-18)-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.