Hot FlashesNCT03572153
A Mind-Body Intervention for Hot Flash Management
A study testing Self-Administered Hypnosis and Self-Administered White Noise Hypnosis in people with Hot Flashes and Postmenopausal Symptoms, run by Baylor University at 2 sites in United States.
Trial summary
The long-term goal of this program of research is to determine safe and effective non-hormonal interventions for menopausal symptoms. The main goal of this study is to evaluate whether self-administered hypnosis can be used to significantly reduce hot flashes more than self-administered white noise hypnosis over 6… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hot Flashes, Postmenopausal Symptoms, Breast Cancer
- What is being tested?
- Self-Administered Hypnosis and Self-Administered White Noise Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2019to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Postmenopausal as defined by one of the following criteria:
- No menstrual period in the past 12 months
- Chemical menopause (LHRH antagonists)
- Surgical Menopause (bilateral oophorectomy)
- Evidence of menopause status per FSH and estradiol levels per institutional guidelines. Self-reported history of a minimum of 4 hot flashes per day or 28 hot flashes per week at baseline.
- Age over 18 years and able to give consent for participation in the study.
- Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment (Vitamin E will be allowed)
- Women with a diagnosis of DCIS or invasive breast cancer stages 0-III are allowed to participate and may be on endocrine therapy of any kind. If on endocrine therapy, women must be on it for 4 weeks and not expected to stop it during the study. If not on endocrine therapy, participants should not be planning to start during the course of the study. However, unexpected treatment will not require study withdrawal but will be recorded and considered in the analysis.
Who cannot join
- Currently receiving other simultaneous treatment for hot flashes (antidepressant use is allowed if being used for mood alterations and participant has been on the antidepressant for at least 3 months with no plans to change dose or antidepressant during this study)
- Diagnosis of clinical depression or acute anxiety disorder
- Currently using any Complementary and Alternative Medicine (CAM) treatments for vasomotor symptoms. (This would include soy products and other phytoestrogens, black cohosh, and any mind-body techniques including meditation, yoga, etc.). If any therapies are used for reasons other than hot flashes and hot flash frequency meets inclusion criteria, then woman is eligible)
- Diagnosis of a serious psychological illness, specifically psychoses, schizophrenia or borderline personality disorder
- Currently using hypnosis for any reason
- PHQ-4 score ≥ 9
- Non-English speaking
- Women with stage IV breast cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Baylor University
Waco, Texas, 76798
About this study
Official title: Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
The long-term goal of this program of research is to determine safe and effective non-hormonal interventions for menopausal symptoms. The main goal of this study is to evaluate whether self-administered hypnosis can be used to significantly reduce hot flashes more than self-administered white noise hypnosis over 6 weeks of home practice. The investigators are also examining the impact of each hypnosis group on sleep, anxiety, perceived and measured stress, heart rate variability, and daily activities.
Read the detailed description
This randomized, two arm clinical trial will evaluate the efficacy of self-administered hypnosis for the treatment of hot flashes in postmenopausal women using a 1:1 randomization schedule.
Primary Objective
To evaluate the efficacy of the self-administered hypnosis intervention for hot flashes compared to the self-administered white noise hypnosis.
Hypothesis 1: Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 6 weeks.
Secondary Objectives
To evaluate the efficacy of the self-administered hypnosis compared to self-administered white noise hypnosis for hot flash activity interference, sleep disturbance, anxiety and perception of benefit; with the expectation that there will be significant improvements among participants in the self-administered hypnosis group when compared with the self-administered white noise hypnosis group at 6 weeks. The investigators will also evaluate the effects of self-administered hypnosis compared to the self-administered white noise hypnosis at 12 weeks for all secondary outcomes except perception of benefit. Additionally, mediators (perceived stress, cortisol, and heart rate variability (HRV)) and moderators (hypnotizability and practice adherence) of hot flash reduction will be explored.
Hypothesis 2.1: Compared to self-administered white noise hypnosis, the self-administered hypnosis intervention will result in significant improvements in hot flash activity interference, sleep disturbance, and anxiety at 6 and 12 weeks, and perception of benefit at 6 weeks.
Hypothesis 2.2 A decrease in perceived stress will be indicated in the self-administered hypnosis group due to the intervention, which will correspond and contribute to further decrease of the hot flash score at 6 and 12 weeks.
Hypothesis 2.3 Diurnal salivary cortisol will demonstrate better circadian rhythms (steeper slopes) in those with larger hot flash reductions and in the self-administered hypnosis group compared to participants in the self-administered white noise hypnosis at 6 weeks.
Hypothesis 2.4 Self-administration of hypnosis and greater hot flash reductions will result in higher resting and 24-hour parasympathetic activity, reflected as higher HRV at 6 weeks.
Hypothesis 2.5 Higher hypnotizability scores and better adherence rates will be associated with greater reductions in hot flash scores in the self-administered hypnosis group.
Hypothesis 2.6 Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 12 weeks.
Recruitment Plan
Potential participants will be identified in three ways: postcard mailings and invitation letters; physician referrals and IRB approved chart screening; and flyers, advertisements and press releases. Physician referrals will come primarily from cancer centers at University of Michigan Cancer Center Breast Clinic in Ann Arbor, MI, and the Baylor Scott \& White Health Center in Waco, TX.
At Michigan, key eligibility criteria will be used to identify potential eligible women through the Honest Broker Office. Charts will be further screened, with IRB approval, for eligibility. If eligible, women will be sent an invitation letter where they can opt in or out of being contacted to learn more about the study.
In addition, at Michigan, outreach will occur through obstetrics and gynecology, mammography, and internal medicine clinics to enable recruitment of women without a history of breast cancer. Mass mailings and local advertisement may also be used.
At Baylor University, a successful and proven method of accrual has been the use of mass mailings and local advertisement (e.g. newspaper, magazines, flyers). Additionally, Dr. Elkins is a medical associate with Baylor Scott \& White Health Center, which provides a direct connection with physicians and medical staff who will provide potential referrals.
It is expected that each site (Baylor University and University of Michigan) will recruit approximately half of the participants. Accrual will be closely monitored and efforts to randomize an equal number at each site will be made.
The study coordinators will provide education about the trial and a consent form for review both by phone and at the baseline/consent session. All other education beyond the baseline data collection will be provided at the second session 7-30 days later. Both sessions will be between 45-60 minutes. Sessions will be held at Dr. Barton's and Dr. Elkin's research offices, which each provide privacy, a recliner, a relaxing environment, and convenient parking.
- Conditions
- Hot Flashes, Postmenopausal Symptoms, Breast Cancer
- Being tested
- Self-Administered Hypnosis, Self-Administered White Noise Hypnosis
- Keywords
- Hot Flashes, Postmenopausal Symptoms, Hypnotic Relaxation Therapy, Mind Body, Hypnosis
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Administered HypnosisBehavioural
Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
Self-Administered White Noise HypnosisBehavioural
Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Self-Administered Hypnosis | Experimental | 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. Receives: Behavioral: Self-Administered Hypnosis |
| Self-Administered White Noise Hypnosis | Active comparator | 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. Receives: Behavioral: Self-Administered White Noise Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot Flash Daily Diary
Participants completed the Hot Flash Daily Diary (Sloan et al., 2001) every day for 6 weeks to measure the daily frequency and severity (mild, moderate, severe, and very severe) of hot flashes. A total hot flash score was calculated for each participant (product of frequency x severity) after severity ratings were assigned a point value as follows:
- mild = 1
- moderate = 2
- severe = 3
- very severe = 4 The hot flash score was then calculated by multiplying the participants' frequency and severity ratings of hot flashes, divided by the total number of days. A lower score indicates less frequent and/or severe hot flashes.
Measured: The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).
Secondary outcomes (5)
Hot Flash Related Daily Interference Scale
This is a 10-item scale that measures hot flash interference. The Hot Flash Related Daily Interference Scale asks respondents to rate the degree on a 0 (not at all) - 10 (very much so) scale that the hot flashes interfere with various daily activities as well as overall enjoyment or quality of life. The total score will range from 0-100. The higher the total score, the more likely hot flashes are interfering with the daily activities.This measure has been shown to be valid and internally consistent with Cronbach's alpha of .96.
Measured: The Hot Flash Related Daily Interference Scale was completed at Baseline (week 0), at endpoint (week 6) and at follow-up (week 12).
Emotional Distress Anxiety Scale
This 29-item scale measures 5 domains of anxiety: 1) affective, 2)cognitive, 3) somatic, 4) behavioral, and 5) need for treatment. Items are scored on a scale from 1 (never) - 5 (always) with higher scores reflecting more severe anxiety. The total range for this scale is 0-145. This scale has shown excellent convergent and discriminate validity with other measures with a Cronbach's alpha .95.
Measured: Baseline, 6 & 12 Weeks
Pittsburgh Sleep Quality Index
This is a 19-item self-report inventory designed to measure sleep disturbance. The 19 items are grouped into 7 sub-scales: 1) sleep quality; 2) sleep efficiency; 3) daytime dysfunction; 4) sleep latency; 5) sleep disturbances; 6) sleep duration; and 7) use of sleep medication.These seven sub-scales are scored on a scale of 0 (better) - 3 (worse) with higher scores indicating greater sleep pathology. The sub-scales are then added for a combined total score ranging from 0 (better) - 21 (worse). Alphas for the Pittsburgh Sleep Quality Index range from .70 to .80.
Measured: Baseline, 6, & 12 weeks.
Subject Global Impression of Change
Participants were asked to fill out the Subject Global Impressions of Change at endpoint (week 6) to gauge participants' perceived benefit. The Subject Global Impression of Change is a single item in which the participant rates, from 0 to 4, the change in hot flashes since beginning the study. Response options range from "not at all" (0), "a little" (1), "somewhat" (2), "quite a bit" (3), "totally satisfied" (4). The question used was, "How satisfied are you with the impact of the study treatment on your hot flashes?". This question has been used extensively for determination of minimally clinically significant differences in numerous oncology clinical trials prior to this study.
Measured: The Subject Global Impressions of Change will be completed only at 6 weeks.
Perceived Stress Scale
This is a 10-item scale that measures the degree to which situations in one's life are appraised as stressful. The scale provides the degree to which individuals find their lives to be unpredictable, uncontrollable, and overloaded, as well as measures the current levels of experienced stress. Items are scored on a scale from 0 (never) - 4(very often) for a total score ranging from 0-40. with higher scores reflecting more perceived stress. This measure has been shown to be valid and internally consistent, with an alpha of .83.
Measured: Baseline, 6, & 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start4 Mar 2019
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Michigan
- Responsible party
- Principal investigator, Gary R. Elkins, Baylor University
- Investigators
- Gary Elkins, Ph.D., Principal investigator, Baylor UniversityDebra Barton, RN,PhD,FAAN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572153
- Sponsor's protocol ID
- 1237087
- Other IDs
- R01AT009384, 2018.063, HUM00146427
- Status last verified
- May 2025
- First submitted
- 17 Jun 2018
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elkins G, Arring N, Morgan G, Lorenz T, Muniz V, Lafferty C, Scheffrahn K, Alldredge C, Barton D. Self-Administered Hypnosis vs Sham Hypnosis for Hot Flashes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2542537. doi: 10.1001/jamanetworkopen.2025.42537.
PubMed 41217756
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03572153
- Acronym / sponsor ID
- 1237087
- Conditions
- Hot Flashes, Postmenopausal Symptoms, Breast Cancer
- Keywords
- Hot Flashes, Postmenopausal Symptoms, Hypnotic Relaxation Therapy, Mind Body, Hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Michigan
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal of this program of research is to determine safe and effective non-hormonal interventions for menopausal symptoms. The main goal of this study is to evaluate whether self-administered hypnosis can be used to significantly reduce hot flashes more than self-administered white noise hypnosis over 6 weeks of home practice. The investigators are also examining the impact of each hypnosis group on sleep, anxiety, perceived and measured stress, heart rate variability, and daily activities.
Detailed description
This randomized, two arm clinical trial will evaluate the efficacy of self-administered hypnosis for the treatment of hot flashes in postmenopausal women using a 1:1 randomization schedule.
Primary Objective
To evaluate the efficacy of the self-administered hypnosis intervention for hot flashes compared to the self-administered white noise hypnosis.
Hypothesis 1: Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 6 weeks.
Secondary Objectives
To evaluate the efficacy of the self-administered hypnosis compared to self-administered white noise hypnosis for hot flash activity interference, sleep disturbance, anxiety and perception of benefit; with the expectation that there will be significant improvements among participants in the self-administered hypnosis group when compared with the self-administered white noise hypnosis group at 6 weeks. The investigators will also evaluate the effects of self-administered hypnosis compared to the self-administered white noise hypnosis at 12 weeks for all secondary outcomes except perception of benefit. Additionally, mediators (perceived stress, cortisol, and heart rate variability (HRV)) and moderators (hypnotizability and practice adherence) of hot flash reduction will be explored.
Hypothesis 2.1: Compared to self-administered white noise hypnosis, the self-administered hypnosis intervention will result in significant improvements in hot flash activity interference, sleep disturbance, and anxiety at 6 and 12 weeks, and perception of benefit at 6 weeks.
Hypothesis 2.2 A decrease in perceived stress will be indicated in the self-administered hypnosis group due to the intervention, which will correspond and contribute to further decrease of the hot flash score at 6 and 12 weeks.
Hypothesis 2.3 Diurnal salivary cortisol will demonstrate better circadian rhythms (steeper slopes) in those with larger hot flash reductions and in the self-administered hypnosis group compared to participants in the self-administered white noise hypnosis at 6 weeks.
Hypothesis 2.4 Self-administration of hypnosis and greater hot flash reductions will result in higher resting and 24-hour parasympathetic activity, reflected as higher HRV at 6 weeks.
Hypothesis 2.5 Higher hypnotizability scores and better adherence rates will be associated with greater reductions in hot flash scores in the self-administered hypnosis group.
Hypothesis 2.6 Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 12 weeks.
Recruitment Plan
Potential participants will be identified in three ways: postcard mailings and invitation letters; physician referrals and IRB approved chart screening; and flyers, advertisements and press releases. Physician referrals will come primarily from cancer centers at University of Michigan Cancer Center Breast Clinic in Ann Arbor, MI, and the Baylor Scott \& White Health Center in Waco, TX.
At Michigan, key eligibility criteria will be used to identify potential eligible women through the Honest Broker Office. Charts will be further screened, with IRB approval, for eligibility. If eligible, women will be sent an invitation letter where they can opt in or out of being contacted to learn more about the study.
In addition, at Michigan, outreach will occur through obstetrics and gynecology, mammography, and internal medicine clinics to enable recruitment of women without a history of breast cancer. Mass mailings and local advertisement may also be used.
At Baylor University, a successful and proven method of accrual has been the use of mass mailings and local advertisement (e.g. newspaper, magazines, flyers). Additionally, Dr. Elkins is a medical associate with Baylor Scott \& White Health Center, which provides a direct connection with physicians and medical staff who will provide potential referrals.
It is expected that each site (Baylor University and University of Michigan) will recruit approximately half of the participants. Accrual will be closely monitored and efforts to randomize an equal number at each site will be made.
The study coordinators will provide education about the trial and a consent form for review both by phone and at the baseline/consent session. All other education beyond the baseline data collection will be provided at the second session 7-30 days later. Both sessions will be between 45-60 minutes. Sessions will be held at Dr. Barton's and Dr. Elkin's research offices, which each provide privacy, a recliner, a relaxing environment, and convenient parking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized and either be assigned to the self-hypnosis group or a self-administered white noise hypnosis group.
| Arm | Type | Receives |
|---|---|---|
| Self-Administered Hypnosis | Experimental | Behavioral: Self-Administered HypnosisSelf-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. |
| Self-Administered White Noise Hypnosis | Active comparator | Behavioral: Self-Administered White Noise HypnosisSelf-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- No menstrual period in the past 12 months
- Chemical menopause (LHRH antagonists)
- Surgical Menopause (bilateral oophorectomy)
- Evidence of menopause status per FSH and estradiol levels per institutional guidelines. Self-reported history of a minimum of 4 hot flashes per day or 28 hot flashes per week at baseline.
- Age over 18 years and able to give consent for participation in the study.
Key exclusion criteria (8 listed)
- Currently receiving other simultaneous treatment for hot flashes (antidepressant use is allowed if being used for mood alterations and participant has been on the antidepressant for at least 3 months with no plans to change dose or antidepressant during this study)
- Diagnosis of clinical depression or acute anxiety disorder
- Currently using any Complementary and Alternative Medicine (CAM) treatments for vasomotor symptoms. (This would include soy products and other phytoestrogens, black cohosh, and any mind-body techniques including meditation, yoga, etc.). If any therapies are used for reasons other than hot flashes and hot flash frequency meets inclusion criteria, then woman is eligible)
- Diagnosis of a serious psychological illness, specifically psychoses, schizophrenia or borderline personality disorder
- Currently using hypnosis for any reason
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 |
|---|---|---|
| Self-Administered HypnosisParticipants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options. | Behavioural | Self-Administered Hypnosis |
| Self-Administered White Noise HypnosisParticipants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options. | Behavioural | Self-Administered White Noise Hypnosis |
Primary outcome
Hot Flash Daily Diary
Time frame: The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).
Participants completed the Hot Flash Daily Diary (Sloan et al., 2001) every day for 6 weeks to measure the daily frequency and severity (mild, moderate, severe, and very severe) of hot flashes. A total hot flash score was calculated for each participant (product of frequency x severity) after severity ratings were assigned a point value as follows: * mild = 1 * moderate = 2 * severe = 3 * very severe = 4 The hot flash score was then calculated by multiplying the participants' frequency and severity ratings of hot flashes, divided by the total number of days. A lower score indicates less frequent and/or severe hot flashes.
5 secondary outcomes
Hot Flash Related Daily Interference Scale
Time frame: The Hot Flash Related Daily Interference Scale was completed at Baseline (week 0), at endpoint (week 6) and at follow-up (week 12).
Emotional Distress Anxiety Scale
Time frame: Baseline, 6 & 12 Weeks
Pittsburgh Sleep Quality Index
Time frame: Baseline, 6, & 12 weeks.
Subject Global Impression of Change
Time frame: The Subject Global Impressions of Change will be completed only at 6 weeks.
Perceived Stress Scale
Time frame: Baseline, 6, & 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41217756Elkins G, Arring N, Morgan G, Lorenz T, Muniz V, Lafferty C, Scheffrahn K, Alldredge C, Barton D. Self-Administered Hypnosis vs Sham Hypnosis for Hot Flashes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2542537. doi: 10.1001/jamanetworkopen.2025.42537.
Related trials for Hot Flashes
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Active, not recruitingPhase 3
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Hot Flashes
Not yet recruiting
Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
Not yet recruiting
Self-Management Box on Hot Flash in Postmenopausal Women
Postmenopausal Flushing, Postmenopausal Symptoms
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.
Gary Elkins, Ph.D. principal investigator
Baylor University
Debra Barton, RN,PhD,FAAN principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Administered Hypnosis and Self-Administered White Noise Hypnosis in people with Hot Flashes and Postmenopausal Symptoms, run by Baylor University at 2 sites 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 8 inclusion and 8 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hot Flash Daily Diary (time frame: The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572153, which also lists 1 linked publication.
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 5 Jun 2025.