NCT05240196

Brief 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. 1.Retrospectively from previous experience
  2. 2.Actual pain, if any, during planned mammogram Patients will be randomised to the following groups;

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

February 4, 2022

Last Update Submit

March 8, 2022

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score from previous mammography compared with pain score reported at current mammography appointment

    Reported pain score for previous mammography experience compared with the pain score reported for current mammography appointment. Pain will be measured using a validated numerical 11 point pain score scale.

    pain score collected within 10 minutes post mammograph

Secondary Outcomes (1)

  • comparison of pain scores reported for each study group

    comparison to take place within 3 months post mammography visit

Study Arms (3)

Control

NO INTERVENTION

participant will receive standard care only

Binaural music

OTHER

Participants will listen to binaural music whilst having a routine mammogram

Other: music

Non-binaural music

OTHER

Participants will listen to non-binaural music whilst having a routine mammogram

Other: music

Interventions

musicOTHER

playing binaural or non-binaural music

Binaural musicNon-binaural music

Eligibility Criteria

Age40 Years - 100 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral mammogram.
  • Asymptomatic patients only.
  • Patients attending for family history follow up mammography.
  • Patients that have had a mammogram within 2 years at the trust to compare to on the same equipment.
  • Patients with language barriers if an interpreter or relative is available.

You may not qualify if:

  • Patients with mammography elsewhere including screening units or in the private sector.
  • Family history patients having their 1st mammogram. Patients with breast implants. Patients with inability to consent due to mental incapacity. Patients with hearing impairments Patients with a history of epilepsy Patients with ongoing mental health illness Patients with heart arrhythmia and pacemakers Patients taking prescribed pain medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tameside and Glossop Integrated Care NHS Foundation Trust

Manchester, OL6 9RW, United Kingdom

Location

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Debbie Nelson

    Tameside and Glossop Integrated Care NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Patients will be randomised to the following groups; 1. Control 2. Binaural music 3. Non binaural music
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 15, 2022

Study Start

January 14, 2020

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

GB(1)