Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
2 other identifiers
interventional
84
1 country
1
Brief Summary
The goal of this behavioral research study is to learn if taking part in guided relaxation programs helps to reduce anxiety and pain during stereotactic breast biopsy. The study will also examine whether the guided relaxation programs change brain activity, heart rate, and blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 26, 2012
CompletedFirst Submitted
Initial submission to the registry
January 13, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedSeptember 7, 2023
September 1, 2023
9.8 years
January 13, 2017
September 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)
Trial considered successful if over 50% of eligible patients participate and at least 80% of the consented patients complete the sessions and all the measures for the study.
1 day
Secondary Outcomes (1)
Effect of GM Compared to Focused Breathing (FB) and Standard Care (SC) Control Groups on Self-Reported Anxiety in Participants Undergoing SBB
3-5 minute intervals throughout the SBB procedure
Study Arms (3)
Guided Meditation Group (GM)
EXPERIMENTALParticipants 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.
Focused Breathing Group (FB)
ACTIVE COMPARATORParticipants 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..
Standard of Care Group (SC)
ACTIVE COMPARATORParticipants 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.
Interventions
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 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.
Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
Eligibility Criteria
You may qualify if:
- Women must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
- Women must be right hand dominant.
- Women must be 18 years or older.
You may not qualify if:
- Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- Women with a score of 3 or below on the Six-Item Cognitive Screener.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo Cohen, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2017
First Posted
January 18, 2017
Study Start
October 26, 2012
Primary Completion
August 10, 2022
Study Completion
August 10, 2022
Last Updated
September 7, 2023
Record last verified: 2023-09