Meditation for Breast BiopsyNCT03023215
Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
A study testing Meditation, Electroencephalogram and Questionnaires in people with Meditation for Breast Biopsy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Meditation for Breast Biopsy
- What is being tested?
- Meditation, Electroencephalogram and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2012to 10 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
Baseline Data Collection:
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
- Meditation for Breast Biopsy
- Being tested
- Meditation, Electroencephalogram, Questionnaires, Heart Rate
- Keywords
- Meditation, Breast Biopsy, Stereotactic Breast Biopsy, SBB, Guided meditation, Focused breathing, Electroencephalogram, EEG, Heart rate, HR, Questionnaires, Surveys
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationProcedure or surgery
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 or surgery
Also called EEG
Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
QuestionnairesBehavioural
Also called Surveys
Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
Heart RateProcedure or surgery
Also called HR
Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
| Study group | Role | What they receive |
|---|---|---|
| Guided Meditation Group (GM) | Experimental | 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. Receives: Procedure: Meditation; Procedure: Electroencephalogram; Behavioral: Questionnaires; Procedure: Heart Rate |
| Focused Breathing Group (FB) | Active comparator | 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.. Receives: Procedure: Meditation; Procedure: Electroencephalogram; Behavioral: Questionnaires; Procedure: Heart Rate |
| Standard of Care Group (SC) | Active comparator | 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. Receives: Procedure: Electroencephalogram; Behavioral: Questionnaires; Procedure: Heart Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants provide a rating from 0-10, with a rating of 0 indicating ''no anxiety'' and 10 indicating ''worst possible anxiety'' at 3-5 minute intervals throughout the SBB procedure.
Measured: 3-5 minute intervals throughout the SBB procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start26 Oct 2012
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meditation for Breast BiopsyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023215
- Sponsor's protocol ID
- 2011-1094
- Other IDs
- NCI-2017-00506
- Status last verified
- Sep 2023
- First submitted
- 13 Jan 2017
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
- ClinicalTrials.gov ID
- NCT03023215
- Acronym / sponsor ID
- 2011-1094
- Conditions
- Meditation for Breast Biopsy
- Keywords
- Meditation, Breast Biopsy, Stereotactic Breast Biopsy, SBB, Guided meditation, Focused breathing, Electroencephalogram, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 26 Oct 2012 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 18 Jan 2017 (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.
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.
Detailed description
Baseline Data Collection:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Meditation Group (GM) | Experimental | Procedure: Meditation, Procedure: Electroencephalogram, Behavioral: Questionnaires, Procedure: Heart RateParticipants 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 comparator | Procedure: Meditation, Procedure: Electroencephalogram, Behavioral: Questionnaires, Procedure: Heart RateParticipants 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 comparator | Procedure: Electroencephalogram, Behavioral: Questionnaires, Procedure: Heart RateParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| MeditationParticipants 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. | Procedure or surgery | Focused Breathing Group (FB), Guided Meditation Group (GM) |
| ElectroencephalogramAlso: EEGElectroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB. | Procedure or surgery | Focused Breathing Group (FB), Guided Meditation Group (GM), Standard of Care Group (SC) |
| QuestionnairesAlso: SurveysSelf-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB. | Behavioural | Focused Breathing Group (FB), Guided Meditation Group (GM), Standard of Care Group (SC) |
| Heart RateAlso: HRHeart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB. | Procedure or surgery | Focused Breathing Group (FB), Guided Meditation Group (GM), Standard of Care Group (SC) |
Primary outcome
Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB)
Time frame: 1 day
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 secondary outcome
Effect of GM Compared to Focused Breathing (FB) and Standard Care (SC) Control Groups on Self-Reported Anxiety in Participants Undergoing SBB
Time frame: 3-5 minute intervals throughout the SBB procedure
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 7 Sep 2023.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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.
Lorenzo Cohen, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation, Electroencephalogram and Questionnaires in people with Meditation for Breast Biopsy, run by M.D. Anderson Cancer Center 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 3 inclusion and 3 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 7 Sep 2023. 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?
Participation and Completion Rate of Incorporating a Guided Meditation Program in Participants Undergoing Stereotactic Breast Biopsy (SBB) (time frame: 1 day). 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 7 Sep 2023.