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Mind-Body Intervention for Hot Flashes
N/A
Waitlist Available
Led By Debra Barton, RN,PhD,FAAN
Research Sponsored by Baylor University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline
Awards & highlights
Study Summary
This trial is testing whether self-hypnosis can help reduce hot flashes better than white noise hypnosis. They will also look at how each type of hypnosis impacts stress, sleep, anxiety, and heart rate variability.
Eligible Conditions
- Hot Flashes
- Breast Cancer
- Postmenopausal Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily during weeks 1-6 of the intervention and during week 12.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily during weeks 1-6 of the intervention and during week 12.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hot Flash Daily Diary
Secondary outcome measures
Diurnal Cortisol Rhythm
Hot Flash Related Daily Interference Scale
Measures of Heart Rate Variability
+5 moreOther outcome measures
Elkins Hypnotizability Scale
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-Administered HypnosisExperimental Treatment1 Intervention
Self-administered hypnosis will be practiced daily using different audio recordings using the researcher's voice. Participants will practice hypnosis at home after completing the two study sessions.
Group II: Self-Administered White Noise HypnosisActive Control1 Intervention
Self-administered white noise hypnosis will be practiced daily using a white noise recording. Participants will practice hypnosis at home after completing the two consent and education sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Self-Administered Hypnosis
2018
N/A
~290
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Who is running the clinical trial?
Baylor UniversityLead Sponsor
56 Previous Clinical Trials
64,917 Total Patients Enrolled
1 Trials studying Hot Flashes
187 Patients Enrolled for Hot Flashes
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
669,493 Total Patients Enrolled
13 Trials studying Hot Flashes
1,597 Patients Enrolled for Hot Flashes
University of MichiganOTHER
1,807 Previous Clinical Trials
6,383,129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women with advanced stage breast cancer that has spread to other parts of the body.You have been diagnosed with severe depression or anxiety.You have been diagnosed with a severe mental illness such as schizophrenia, psychoses or borderline personality disorder.You are currently undergoing hypnosis for any reason.You are taking medication to treat hot flashes, except for antidepressants that have been used for mood issues for at least 3 months and won't be changed during the study.You are currently using alternative medicine treatments, like herbal supplements or meditation, to help with hot flashes. If you are using these therapies for something other than hot flashes and still meet the criteria for hot flash frequency, you may still be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Self-Administered White Noise Hypnosis
- Group 2: Self-Administered Hypnosis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is participation in this trial expanding?
"Affirmative. The clinicaltrials.gov page reveals that 232 subjects are being sought for a trial which was initially posted on November 15th 2018, and modified most recently on July 18th 2022. All recruitment is taking place at one location."
Answered by AI
Are there still vacancies available for participants in this medical trial?
"Per the information provided by clinicaltrials.gov, this study is presently recruiting participants for its research. Initially posted on November 15th 2018, it was most recently updated July 18th 2022."
Answered by AI
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