Binaural music study

• Research type

  Research Study

• Full title

  Does actively listening to binaural music immediately prior to mammography reduce a patient's pain score from applied compression during the procedure?

• IRAS ID

  246720

• Contact name

  Deborah Nelson

• Contact email

  debbie.nelson@tgh.nhs.uk

• Sponsor organisation

  Tameside and Glossop Integrated care Foundation Trust

• Clinicaltrials.gov Identifier

  NCT05240196

• Duration of Study in the UK

  0 years, 4 months, 3 days

• Research summary

  To evaluate client experience relating to mammography and pain scores for patients attending for annual surveillance mammography with a family history of breast cancer. It will involve face to face patient interviews with clients that have had previous mammography at the study site (Tameside and Glossop Integrated Care Trust). The data will be specific to the study site and gathered by the PI only. This is a feasibility study, the data will be used to inform further study across additional sites and application for a College of Radiographers grant.
  The study is a quantitative assessment of pain following the intervention of binaural music, the mammogram will be undertaken by the same mammographer to standardise technique. Pain will be assessed using a validated numerical 11 point pain score for ease of use as per previous published research.

  Each client will feedback twice during the care event:

  1. Retrospectively from previous experience
  2. Actual pain, if any, during planned mammogram

  Patients will be randomised to the following groups;
  1. Control
  2. Binaural music
  3. Non binaural music
  If the feasibility study is successful the study will proceed to a second phase and the number of participants extended to 60 patients per group (180 in total) and the study ceased when the number reached.
  If there is an indication to extend to another Trust (multi-site trial). A new IRAS application will be submitted following the feasibility study, if successful.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  19/NW/0728

• Date of REC Opinion

  13 Jan 2020

• REC opinion

  Further Information Favourable Opinion