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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
Date results information initially provided
31/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Mindful breathing intervention for breathlessness in Chronic obstructive pulmonary disease
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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
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Secondary ID [1]
297760
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breathlessness
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Condition category
Condition code
Respiratory
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
324823
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Treatment: Other
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Change in self-efficacy assessed using the COPD Self-Efficacy Scale
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Assessment method [1]
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Timepoint [1]
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Pre-commencement of the intervention. and nine weeks post-commencement of the intervention.
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Primary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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At the three month follow-up point post completion of the intervention
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Primary outcome [3]
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The feasibility study will assess participant adherence to the mindful breathing intervention and daily diary and the usefulness of the proposed data set.
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Assessment method [3]
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Timepoint [3]
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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.
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Secondary outcome [1]
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Change in breathlessness assessed using the Medical Research Council (MRC) Dyspnoea Scale
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Assessment method [1]
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Timepoint [1]
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Pre-commencement of the intervention. and nine weeks post-commencement of the intervention. and documented in the daily dairy
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Secondary outcome [2]
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Change in Mindfulness assessed using the 5-facet questionnaire short form .
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Assessment method [2]
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Timepoint [2]
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Pre-commencement of the intervention. and nine weeks post-commencement of the intervention.
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
not applicable
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
30/07/2023
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Actual
30/07/2023
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Date of last participant enrolment
Anticipated
30/10/2023
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Actual
19/12/2023
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Date of last data collection
Anticipated
30/06/2024
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Actual
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Canterbury
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Otago (Christchurch )
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Address [1]
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Level 3
72 Oxford terrace
Christchurch 8140
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Otago (Christchurch )
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Address
Level 3
72 Oxford terrace
Christchurch 8140
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
314227
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern B Health and disability Ethics Committee
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Ethics committee address [1]
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Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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30/11/2022
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Approval date [1]
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14/04/2023
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Ethics approval number [1]
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2023 FULL 15152
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Summary
Brief summary
A feasibility study with a single group pre-post programme study design to explore acceptability of a novel mindful breathing intervention and to collect preliminary data regarding the interventions effectiveness. The feasibility study will assess the efficacy of the recruitment strategy in recruiting potential participants and the required recruitment timeframe, the characteristics of the proposed outcome measures and response rates, participant adherence to the mindful breathing intervention and daily diary and the usefulness of the proposed data set.
A qualitative study exploring participant experience of the mindful breathing intervention (Three months post intervention).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Shirley K A Harris
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Address
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Centre for Postgraduate Nursing (University of Otago - Christchurch)
PO Box 4345, 72 Oxford Terrace
Christchurch
8041
New Zealand
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Country
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New Zealand
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Phone
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+64 0273500529
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Fax
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none
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Shirley K A Harris
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Address
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Centre for Postgraduate Nursing (University of Otago - Christchurch)
PO Box 4345, 72 Oxford Terrace
Christchurch
8041
New Zealand
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Country
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New Zealand
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Phone
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+64 0273500529
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Fax
91987
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none
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mrs Shirley K A Harris
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Address
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Centre for Postgraduate Nursing (University of Otago - Christchurch)
PO Box 4345, 72 Oxford Terrace
Christchurch
8041
New Zealand
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Country
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New Zealand
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Phone
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+64 0273500529
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Fax
91988
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none
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Email
91988
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18147
Study protocol
[email protected]
377232-(Uploaded-28-02-2023-10-00-35)-Study-related document.docx
18148
Informed consent form
[email protected]
377232-(Uploaded-28-02-2023-09-59-07)-Study-related document.doc
19123
Ethical approval
[email protected]
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.
Download to PDF