None listed
Conditions
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).
Interventions
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 experti
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.
Sponsors
University of Otago (Christchurch )
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
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.
Outcome results
None listed