Binaural Music Study
Condition: Pain
Study type: Interventional

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.
    

Detailed description: 
      Principal aim of the study: To investigate whether the experience of mammography-related pain
      can be improved by listening to binaural music prior to the examination.

      The research aims to improve patient experience for patients undergoing annual mammography
      with moderate or high risk of breast cancer. These patients can commence annual mammography
      at 40 years of age until entering the National Health Service Breast Screening Program
      (NHSBSP), (NICE, 2013). Reduction in pain or anxiety for these patients may improve
      compliance, reduce DNA rates which is a cost saving to the NHS.

      Previously, mammography-related pain scores have been evaluated within the study institution
      in these groups of women by measuring pain using a VAS/NRS pain tool three times; before,
      immediately after and 1-week post mammography. The results of this study showed that
      expectation of pain by the patient was the only significant predictor for pain r=0.79. Breast
      size, compression force, menopausal status and breast density were not found to be
      significant indicators for pain (Nelson et al., 2018).

      One of the action points for this research was to repeat the study within the introduction of
      a series of pain interventions to improve pain scores for all patients in the low, moderate
      and severe pain categories.

      f. Methodology The feasibility study will be a prospective, randomised controlled trial
      enabling comparisons based on current pain measurements, for patients attending family
      history screening at Tameside and Glossop Integrated Care NHS Foundation Trust. If the
      results are significant then a larger scale study across 2-3 sites is planned.

      The patient information sheet (PIS) will be posted with the appointment letter and the
      patients will have 2 weeks to read the letter and contact the researcher with any questions
      or concerns prior to their mammogram appointment.

      Allocation to the group will be randomised prior to mammogram by selection using an online
      randomisation tool until the sample size is reached for each group (control, non binaural
      music, binaural music). The patients will be asked to participate in the study and will not
      know which group they are in until instructions are given just prior to the examination. The
      control group will be asked to score their pain before and after routine mammography without
      actively listening to music.

      The patient will be asked to self-evaluate their pain from their most recent previous
      mammogram from memory using a validated 11-point numerical scale where zero = no pain and 10
      = the worst pain. The patient will then be asked to score their pain following their current
      mammogram and this will be recorded on a second validated 11-point numerical scale (Yale
      2018). The information will be recorded by the mammographer for improved consistency and
      scanned into the radiology information system as a permanent record. The same mammographer
      will perform the mammograms to standardise technique, the compression given will remain at
      her discretion. Music will be standardised and played using personal headphones for 5 minutes
      prior to mammography
    

Intervention name(s): music
Intervention type(s): Other
Intervention description(s): playing binaural or non-binaural music
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomised to the following groups;
Control
Binaural music
Non binaural music
Masking: None (Open Label)
Primary purpose: Basic Science