NCT02924441

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
251

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Oct 2016

Longer than P75 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

First Submitted

Initial submission to the registry

September 8, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

September 8, 2016

Last Update Submit

October 10, 2022

Conditions

Pain

Keywords

MammogramPain ManagementLidocaine

Outcome Measures

Primary Outcomes (1)

  • 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).

    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).

Study Arms (4)

Right Breast Lidocaine and calming music

EXPERIMENTAL

Group 1 - right breast lidocaine \& calming music

Other: LidocaineOther: Calming Music

Right Breast Lidocaine and no music

EXPERIMENTAL

Group 2 - right breast lidocaine \& no calming music

Other: LidocaineOther: No Music

Left Breast Lidocaine and calming music

EXPERIMENTAL

Group 3 - left breast lidocaine \& calming music

Other: LidocaineOther: Calming Music

Left Breast Lidocaine and no music

EXPERIMENTAL

Group 4 - left breast lidocaine \& no calming music

Other: LidocaineOther: No Music

Interventions

LidocaineOTHER

Applied to breast skin

Also known as: Topicaine
Left Breast Lidocaine and calming musicLeft Breast Lidocaine and no musicRight Breast Lidocaine and calming musicRight Breast Lidocaine and no music
Calming MusicOTHER

Played during mammography

Left Breast Lidocaine and calming musicRight Breast Lidocaine and calming music
No MusicOTHER

No music played during mammography

Left Breast Lidocaine and no musicRight Breast Lidocaine and no music

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must either be getting her first mammogram or based on prior experience be expecting level 4 or 5 pain.
  • Must have two breasts

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Health Cancer Center

San Antonio, Texas, 78260, United States

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kenneth Kist, MD

    CTRC @ UTHSCSA

    PRINCIPAL INVESTIGATOR

  • Virginia Kaklamani, MD

    CTRC @ UTHSCSA

    STUDY CHAIR

  • Pamela Otto, MD

    CTRC @ UTHSCSA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

October 5, 2016

Study Start

October 1, 2016

Primary Completion

January 15, 2020

Study Completion

August 3, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)