PainNCT02924441
Women's Mammography Study to Improve Comfort During Mammography
A study testing Lidocaine, Calming Music and No Music in people with Pain, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
To determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine, Calming Music and No Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 3 Aug 2022
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain.
- Must have two breasts
Who cannot join
- May not have taken ibuprofen or other pain medication within the Space last 12 hours (ASA 81 mg dose is allowed).
- Must not have a contraindication for using lidocaine: e.g no history of allergic reactions to lidocaine.
- Must not have had history of breast cancer, breast surgery, radiation to the chest wall.
- Must not have broken or irritated skin (as determined by the study nurses).
- May not be lactating or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Attempting to Improve the Comfort During Screening Mammography
To determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram.
Read the detailed description
The study is designed to evaluate two methods of reducing pain and anxiety caused by mammography, one of the barriers to the procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineOther
Also called Topicaine
Applied to breast skin
Calming MusicOther
Played during mammography
No MusicOther
No music played during mammography
| Study group | Role | What they receive |
|---|---|---|
| Right Breast Lidocaine and calming music | Experimental | Group 1 - right breast lidocaine \& calming music Receives: Other: Lidocaine; Other: Calming Music |
| Right Breast Lidocaine and no music | Experimental | Group 2 - right breast lidocaine \& no calming music Receives: Other: Lidocaine; Other: No Music |
| Left Breast Lidocaine and calming music | Experimental | Group 3 - left breast lidocaine \& calming music Receives: Other: Lidocaine; Other: Calming Music |
| Left Breast Lidocaine and no music | Experimental | Group 4 - left breast lidocaine \& no calming music Receives: Other: Lidocaine; Other: No Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire to determine the change (or difference) in pain level before and after mammogram
The questionnaires will be typically be completed about 60 minutes apart. The first questionnaire will be completed before any intervention. The second questionnaire will be administered at the earliest at about 35 minutes later (after application of the gels and performance of mammography). The longest interval between administration of the questionnaires would be 75 minutes (after which time the gel must be removed, per protocol).
Measured: The questionnaires are completed before and after mammography, on the same day (questionnaire will be completed before leaving the mammography clinic the day of mammography).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion15 Jan 2020
- Study completion3 Aug 2022
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.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Kist, MD, Principal investigator, CTRC @ UTHSCSAVirginia Kaklamani, MD, Study chair, CTRC @ UTHSCSAPamela Otto, MD, Study chair, CTRC @ UTHSCSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924441
- Sponsor's protocol ID
- CTMS 16-0045
- Other IDs
- HSC20160392H
- Status last verified
- Oct 2022
- First submitted
- 8 Sep 2016
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Attempting to Improve the Comfort During Screening Mammography
- ClinicalTrials.gov ID
- NCT02924441
- Acronym / sponsor ID
- CTMS 16-0045
- Conditions
- Pain
- Keywords
- Mammogram, Pain Management, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 5 Oct 2016 (estimated)
- 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 determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram.
Detailed description
The study is designed to evaluate two methods of reducing pain and anxiety caused by mammography, one of the barriers to the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Right Breast Lidocaine and calming music | Experimental | Other: Lidocaine, Other: Calming MusicGroup 1 - right breast lidocaine \& calming music |
| Right Breast Lidocaine and no music | Experimental | Other: Lidocaine, Other: No MusicGroup 2 - right breast lidocaine \& no calming music |
| Left Breast Lidocaine and calming music | Experimental | Other: Lidocaine, Other: Calming MusicGroup 3 - left breast lidocaine \& calming music |
| Left Breast Lidocaine and no music | Experimental | Other: Lidocaine, Other: No MusicGroup 4 - left breast lidocaine \& no calming music |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain.
- Must have two breasts
Key exclusion criteria (5 listed)
- May not have taken ibuprofen or other pain medication within the Space last 12 hours (ASA 81 mg dose is allowed).
- Must not have a contraindication for using lidocaine: e.g no history of allergic reactions to lidocaine.
- Must not have had history of breast cancer, breast surgery, radiation to the chest wall.
- Must not have broken or irritated skin (as determined by the study nurses).
- May not be lactating or breast feeding
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 |
|---|---|---|
| LidocaineAlso: TopicaineApplied to breast skin | Other | Left Breast Lidocaine and calming music, Left Breast Lidocaine and no music, Right Breast Lidocaine and calming music, Right Breast Lidocaine and no music |
| Calming MusicPlayed during mammography | Other | Left Breast Lidocaine and calming music, Right Breast Lidocaine and calming music |
| No MusicNo music played during mammography | Other | Left Breast Lidocaine and no music, Right Breast Lidocaine and no music |
Primary outcome
Questionnaire to determine the change (or difference) in pain level before and after mammogram
Time frame: The questionnaires are completed before and after mammography, on the same day (questionnaire will be completed before leaving the mammography clinic the day of mammography).
The questionnaires will be typically be completed about 60 minutes apart. The first questionnaire will be completed before any intervention. The second questionnaire will be administered at the earliest at about 35 minutes later (after application of the gels and performance of mammography). The longest interval between administration of the questionnaires would be 75 minutes (after which time the gel must be removed, per protocol).
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 12 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Kenneth Kist, MD principal investigator
CTRC @ UTHSCSA
Virginia Kaklamani, MD study chair
CTRC @ UTHSCSA
Pamela Otto, MD study chair
CTRC @ UTHSCSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, Calming Music and No Music in people with Pain, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 2 inclusion and 5 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 12 Oct 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 States. 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?
Questionnaire to determine the change (or difference) in pain level before and after mammogram (time frame: The questionnaires are completed before and after mammography, on the same day (questionnaire will be completed before leaving the mammography clinic the day of mammography).). 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 12 Oct 2022.