Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
NCT ID: NCT03023215
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2012-10-26
2022-08-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Relaxation for Women With Breast Cancer Undergoing Radiotherapy
NCT01202851
Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures
NCT05343975
Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery
NCT03012399
Improving Biopsy Experiences Study for Women
NCT01811043
Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?
NCT02810236
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
If participant chooses to take part in this study, they will be asked to fill out several questionnaires on an MD Anderson computer. Participant will be asked questions about anxiety, pain, and spirituality. The questionnaires will take about 20 minutes to complete.
Participant will have their heart rate and blood pressure taken, which will take about 3 minutes to complete. Participant will then have an electroencephalogram (EEG) done. An EEG is used to view a person's brain waves. The EEG should take about 5 minutes to complete. During the EEG, a snug cap which contains small electrodes will be placed on the head to measure the electrical patterns coming from the brain--much like the way a doctor listens to participant's heart from the surface of their skin. The EEG cap will stay on participant's head until the end of the study.
Study Groups:
After the baseline information is collected, participant will be randomly assigned (as in the role of a die) to 1 of 3 study groups: 2 relaxation training groups or a standard care group. Based on the way the study is designed, there is a 1 in 5 (or 20%) chance that participant will be assigned to the standard care group, and a 4 in 5 (or 80%) chance that participant will be assigned to one of the relaxation groups. Both relaxation groups will focus on helping participant to relax by focusing on their breath. At the end of participation, all groups will be given a 25 minute relaxation audio CD created by the MD Anderson Integrative Medicine Program.
Pre-Breast Biopsy Procedures:
Participants assigned to the relaxation groups will be guided through relaxation techniques for 10 minutes before the biopsy. Participants assigned to the third group will listen to 10 minutes of National Public Radio.
Participant's heart rate and EEG activity will be recorded during this 10-minute period of time. At the end of the 10-minute period before the breast biopsy, participant's blood pressure will be taken again and they will complete a 5 minute questionnaire about anxiety.
Breast Biopsy Procedures:
When it is time for the biopsy procedure, the research assistant will go with participant to their procedure room. In the procedure room, the research assistant will continue to monitor participant's heart rate and EEG activity throughout the biopsy time. If participant is in one of the relaxation groups, the relaxation guide will also accompany participant to the procedure room and will continue to be guided through relaxation during the biopsy procedure. If participant is in the standard care group, they will be provided with the usual breast biopsy care. Participant will be asked to talk about any anxiety and pain at several times during the procedure. Participant will also be asked to rest with their eyes closed during the biopsy procedure.
After the biopsy is finished, the research assistant will go with participant to a separate room, and they will have 5 minutes of EEG activity recorded, and their blood pressure will be taken. The EEG cap will then be removed, and participant will be asked to complete a questionnaire about their experience that will take less than 10 minutes to complete.
This is an investigational study.
Up to 85 participants will take part in this study. All will be enrolled at MD Anderson.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Guided Meditation Group (GM)
Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Meditation
Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
Electroencephalogram
Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Questionnaires
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Heart Rate
Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Focused Breathing Group (FB)
Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB..
Meditation
Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
Electroencephalogram
Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Questionnaires
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Heart Rate
Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Standard of Care Group (SC)
Participants listen to a 10 minute neutral-content audio clip from National Public Radio prior to stereotactic breast biopsy (SBB).
Electroencephalogram (EEG) activity and heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Electroencephalogram
Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Questionnaires
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Heart Rate
Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meditation
Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
Electroencephalogram
Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Questionnaires
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Heart Rate
Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Women must be right hand dominant.
3. Women must be 18 years or older.
Exclusion Criteria
2. Women with a score of 3 or below on the Six-Item Cognitive Screener.
3. Women who plan to take benzodiazepine (e.g, alprazolam, diazepam, clonazepam, lorazepam) or beta-blocker (e.g., propranolol, atenolol) on the day of their SBB.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lorenzo Cohen, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
University of Texas MD Anderson Cancer Center Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2017-00506
Identifier Type: OTHER
Identifier Source: secondary_id
2011-1094
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.