CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Meditation +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03023215
NCT03023215N/ACompleted

Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy

M.D. Anderson Cancer Center·interventional·Posted Jan 18, 2017·Updated Sep 7, 2023

In Brief

A clinical study evaluating Meditation, Electroencephalogram, and 2 other interventions for Meditation for Breast Biopsy. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2017
Enrollment StartOct 26, 2012
Primary CompletionAug 10, 2022
TodayJul 1, 2026
Enrollment to primary: 9.8 yearsPosted 9.5 years ago

Interventions

Meditationprocedure

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.

Electroencephalogramprocedure

Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.

Questionnairesbehavioral

Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.

Heart Rateprocedure

Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.