Anxiety management in breathlessness.
Research type
Research Study
Full title
A scoping study to evaluate the potential of an electronic medical device to treat anxiety in people who experience breathlessness.
IRAS ID
321848
Contact name
Christina Faull
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This research uses questionnaire, interview and participant daily diaries to evaluate the potential of an electronic medical device, Cranial Electrotherapy Stimulation (CES), to treat anxiety in people who experience breathlessness due to advanced lung diseases. The study will look to recruit a minimum of 20 participants. Participants will be allocated to either using the CES intervention of a parallel non-randomised control group.
The research will take place over a period of 8 months with individuals participation in the research being 12-14 weeks with 8 weeks treatment duration for the CES intervention. Participants will be identified from attendance at LOROS and Cynthia Spencer Hospices.
Recruitment to the intervention group will be staggered to develop the most effective and safe ways of working, learning from each participant with very close monitoring of adverse effects and acceptability of treatment. A control group will be recruited in parallel with the interventional group recruitment. Participants can choose which group they wish to be in and reasons for their choice will be explored and recorded to inform tertiary objectives regarding feasibility of a future randomised controlled trial.
The current treatment options for patients with anxiety related to breathlessness are medications which commonly have considerable side effects or cognitive and behavioural management strategies which have limitations, especially for frail patients, and are resource intensive. There is therefore an urgent need to develop new approaches.
Robust research for the use of CES is lacking beyond the context of generalised anxiety disorder in mental health services and there has been no research in the context of anxiety related to breathlessness. If shown to be effective, CES could provide a self-managed, relatively inexpensive treatment for this patient group.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0276
Date of REC Opinion
19 Apr 2023
REC opinion
Favourable Opinion