Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03023215
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2017-01-13
Brief Title:
Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Brief Guided Relaxation for Women Undergoing Stereotactic Breast Biopsy
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 persons 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 participants heart from the surface of their skin The EEG cap will stay on participants 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
Participants 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 participants 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 participants 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
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 persons 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 participants heart from the surface of their skin The EEG cap will stay on participants 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
Participants 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 participants 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2017-00506 | OTHER | NCI CTRP | None |