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Binaural Music Study

NCT05240196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2022-03-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

music

playing binaural or non-binaural music

Sponsors & Collaborators

  • University of Salford

    collaborator OTHER

  • Tameside General Hospital

    lead OTHER

Principal Investigators

  • Debbie Nelson · Tameside and Glossop Integrated Care NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240196 on ClinicalTrials.gov