PainNCT05240196
Binaural Music Study
A study testing music in people with Pain, run by Tameside General Hospital at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 100 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2020to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tameside and Glossop Integrated Care NHS Foundation Trust
Manchester, OL6 9RW
About this study
Official title: Does Actively Listening to Binaural Music Immediately Prior to Mammography Reduce a Patient's Pain Score From Applied Compression During the Procedure
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:
Read more
- Retrospectively from previous experience
- Actual pain, if any, during planned mammogram Patients will be randomised to the following groups;
- 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.
Read the 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.
- 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
- Conditions
- Pain
- Being tested
- music
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
playing binaural or non-binaural music
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | participant will receive standard care only |
| Binaural music | Other | Participants will listen to binaural music whilst having a routine mammogram Receives: Other: music |
| Non-binaural music | Other | Participants will listen to non-binaural music whilst having a routine mammogram Receives: Other: music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pain score collected within 10 minutes post mammograph
Secondary outcomes (1)
comparison of pain scores reported for each study group
Correlation statistics will be used to examine trends between prior pain / comfort levels and the new mammography examination following the interventions
Measured: comparison to take place within 3 months post mammography visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start14 Jan 2020
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to the following groups; 1. Control 2. Binaural music 3. Non binaural music
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tameside General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salford
- Responsible party
- Sponsor
- Investigators
- Debbie Nelson, Principal investigator, Tameside and Glossop Integrated Care NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240196
- Sponsor's protocol ID
- BR/2019/487
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Actively Listening to Binaural Music Immediately Prior to Mammography Reduce a Patient's Pain Score From Applied Compression During the Procedure
- ClinicalTrials.gov ID
- NCT05240196
- Acronym / sponsor ID
- BR/2019/487
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Tameside General HospitalUniversity, hospital or other
- Collaborators
- University of Salford
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Retrospectively from previous experience
- Actual pain, if any, during planned mammogram Patients will be randomised to the following groups;
- 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.
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomised to the following groups; 1. Control 2. Binaural music 3. Non binaural music
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –participant will receive standard care only |
| Binaural music | Other | Other: musicParticipants will listen to binaural music whilst having a routine mammogram |
| Non-binaural music | Other | Other: musicParticipants will listen to non-binaural music whilst having a routine mammogram |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musicplaying binaural or non-binaural music | Other | Binaural music, Non-binaural music |
Primary outcome
Pain score from previous mammography compared with pain score reported at current mammography appointment
Time frame: pain score collected within 10 minutes post mammograph
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.
1 secondary outcome
comparison of pain scores reported for each study group
Time frame: comparison to take place within 3 months post mammography visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbie Nelson principal investigator
Tameside and Glossop Integrated Care NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Pain, run by Tameside General Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score from previous mammography compared with pain score reported at current mammography appointment (time frame: pain score collected within 10 minutes post mammograph). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.