Hot FlashesNCT01293695
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
A study testing Hypnosis and Structured attention in people with Hot Flashes, run by Baylor University at 1 site in United States.
Trial summary
This study is designed to determine the effect of a Hypnosis Intervention on reducing hot flash frequency (perceived impact vs. physiologically measured impact), severity and daily interference in post-menopausal women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Hypnosis and Structured attention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal as defined by:
- no menstrual period in the past 12 months;
- no menstrual period in the past 6 months and a medically documented history of FSH level greater than 40; or
- women who have had a bilateral oophorectomy.
- A self-reported history of a minimum of 7 hot flashes per day or 50 hot flashes per week at baseline.
- Age over 18 years and ability to give her own consent for participation in the study.
- Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment
- Ability to attend weekly sessions.
Who cannot join
- Receiving other simultaneous treatment for hot flashes.
- Using any CAM (Complementary and Alternative Medicine) treatments for vasomotor symptoms • Any medical or psychiatric condition that in the opinion of the investigator puts the participant at potential risk during the study.
- Currently using hypnosis for any reason.
- Inability to speak or understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Mind-Body Medicine Research Lab-Baylor University
Waco, Texas, 76798
About this study
This study is designed to determine the effect of a Hypnosis Intervention on reducing hot flash frequency (perceived impact vs. physiologically measured impact), severity and daily interference in post-menopausal women. It is felt that the Hypnosis Intervention will result in significantly lower hot flash frequency, severity and daily interference scores (perceived impact vs. physiologically measured impact) versus Structured-Attention Control.
Read the detailed description
The aging population of the United States and findings from the Women's Health Initiative that indicate a shift in the risk/benefits balance of hormone therapy have created a growing interest in alternative treatments for hot flashes. Hot flashes are among the most severe and frequent symptoms experienced by women during menopause. Over 66% of post-menopausal women experience hot flashes. As a result, there is a pressing need for safe and effective treatments for hot flashes. Hypnosis is one mind-body therapy that seems particularly promising for treating hot flashes.
However, the treatment effectiveness of hypnosis in reducing physiologically measured (i.e. physiologically measured impact) hot flashes with post-menopausal women has yet to be established relative to a Structured-Attention Control. This is a critical step to further investigate the intervention and to determine if hypnosis reduces the symptoms (i.e. the number of physiological hot flashes) or only the women's perception of symptoms.
Also, the physiologic mechanism by which hypnosis may operate in reducing hot flashes is not known. The present study will compare hypnosis to a Structured-Attention Control in reducing hot flashes (perceived and physiologically monitored) in post-menopausal women in a randomized clinical trial.
Innovations of this study are that it will be the first full scale test of hypnosis for hot flashes; one of the first studies to examine both perceived impact and physiologically measured impact of a mind-body intervention for hot flashes using state-of-the-art 24 hour ambulatory physiological monitoring; the first study to examine the effect of hypnosis for hot flashes on cortisol; and the first investigation of the role of cognitive expectancies in treatment of hot flashes in comparison to a Structured-Attention Control.
- Conditions
- Hot Flashes
- Being tested
- Hypnosis, Structured attention
- Keywords
- hot flashes, post menopausal women, skin conductance monitors, hypnosis, hypnotizability
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
Also called Hypnotic relaxation therapy, Hypnosis relaxation, Hypnotic intervention, Hypnosis intervention
Hypnosis relaxation in five weekly sessions
Structured attentionOther
Also called Placebo Comparator
Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Active comparator | Receives 5 weeks of hypnotic relaxation therapy Receives: Behavioral: Hypnosis |
| Structured Attention | Placebo comparator | Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy Receives: Other: Structured attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hot Flash Frequency
The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).
Measured: 6 Weeks and 12 Weeks
Hot Flash Score
Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome).
Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4).
The values presented represent the average of daily hot flash scores.
Measured: 6 Weeks and 12 Weeks
Hot Flash Related Daily Interference Scale (HFRDIS)
This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.
Measured: 6 Weeks and 12 Weeks
Secondary outcomes (2)
Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture
As a secondary outcome, hot flashes were measured using a Biolog ambulatory recorder. Skin conductance was expressed in micro Siemens (0 to infinity) and the final value was obtained by averaging the recorded skin conductance for a period of 24 hours. Lower skin conductance measure indicates less sweating.
Measured: 6 Weeks and 12 Weeks
Pittsburg Sleep Quality Index (PSQI)
The Pittsburg Sleep Quality Index (PSQI) is a self-report inventory designed to measure sleep quality. The participants self rate their sleep quality over seven areas of sleep.The questions about sleep quality are answered on a 0-3 scale with higher scores indicating greater sleep pathology. The global score is determined by summing the raw scores of the seven sleep components. The global score can range from 0 - 21 and total scores above 5 are normally considered indicative of poor sleep quality.
Measured: 6 Weeks and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startSep 2007
- Primary completionMar 2014
- Study completionMar 2014
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 (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Gary R. Elkins, Baylor University
- Investigators
- Gary R Elkins, Ph.D., Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293695
- Sponsor's protocol ID
- 194610
- Other IDs
- 5U01AT004634
- Status last verified
- Jul 2016
- First submitted
- 10 Feb 2011
- Last updated
- 16 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Roberts RL, Rhodes JR, Elkins GR. Effect of Hypnosis on Anxiety: Results from a Randomized Controlled Trial with Women in Postmenopause. J Clin Psychol Med Settings. 2021 Dec;28(4):868-881. doi: 10.1007/s10880-021-09810-3. Epub 2021 Aug 17.
PubMed 34403019Elkins GR, Fisher WI, Johnson AK. Hypnosis for hot flashes among postmenopausal women study: a study protocol of an ongoing randomized clinical trial. BMC Complement Altern Med. 2011 Oct 11;11:92. doi: 10.1186/1472-6882-11-92.
PubMed 21989181
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01293695
- Acronym / sponsor ID
- 194610
- Conditions
- Hot Flashes
- Keywords
- hot flashes, post menopausal women, skin conductance monitors, hypnosis, hypnotizability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Study start
- Sep 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 17 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine the effect of a Hypnosis Intervention on reducing hot flash frequency (perceived impact vs. physiologically measured impact), severity and daily interference in post-menopausal women. It is felt that the Hypnosis Intervention will result in significantly lower hot flash frequency, severity and daily interference scores (perceived impact vs. physiologically measured impact) versus Structured-Attention Control.
Detailed description
The aging population of the United States and findings from the Women's Health Initiative that indicate a shift in the risk/benefits balance of hormone therapy have created a growing interest in alternative treatments for hot flashes. Hot flashes are among the most severe and frequent symptoms experienced by women during menopause. Over 66% of post-menopausal women experience hot flashes. As a result, there is a pressing need for safe and effective treatments for hot flashes. Hypnosis is one mind-body therapy that seems particularly promising for treating hot flashes.
However, the treatment effectiveness of hypnosis in reducing physiologically measured (i.e. physiologically measured impact) hot flashes with post-menopausal women has yet to be established relative to a Structured-Attention Control. This is a critical step to further investigate the intervention and to determine if hypnosis reduces the symptoms (i.e. the number of physiological hot flashes) or only the women's perception of symptoms.
Also, the physiologic mechanism by which hypnosis may operate in reducing hot flashes is not known. The present study will compare hypnosis to a Structured-Attention Control in reducing hot flashes (perceived and physiologically monitored) in post-menopausal women in a randomized clinical trial.
Innovations of this study are that it will be the first full scale test of hypnosis for hot flashes; one of the first studies to examine both perceived impact and physiologically measured impact of a mind-body intervention for hot flashes using state-of-the-art 24 hour ambulatory physiological monitoring; the first study to examine the effect of hypnosis for hot flashes on cortisol; and the first investigation of the role of cognitive expectancies in treatment of hot flashes in comparison to a Structured-Attention Control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Active comparator | Behavioral: HypnosisReceives 5 weeks of hypnotic relaxation therapy |
| Structured Attention | Placebo comparator | Other: Structured attentionMeets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postmenopausal as defined by:
- A self-reported history of a minimum of 7 hot flashes per day or 50 hot flashes per week at baseline.
- Age over 18 years and ability to give her own consent for participation in the study.
- Have discontinued other putative therapies for hot flashes for at least one month prior to enrollment
- Ability to attend weekly sessions.
Key exclusion criteria (4 listed)
- Receiving other simultaneous treatment for hot flashes.
- Using any CAM (Complementary and Alternative Medicine) treatments for vasomotor symptoms • Any medical or psychiatric condition that in the opinion of the investigator puts the participant at potential risk during the study.
- Currently using hypnosis for any reason.
- Inability to speak or understand English
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 |
|---|---|---|
| HypnosisAlso: Hypnotic relaxation therapy, Hypnosis relaxation, Hypnotic intervention, Hypnosis interventionHypnosis relaxation in five weekly sessions | Behavioural | Hypnosis |
| Structured attentionAlso: Placebo ComparatorMeets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy | Other | Structured Attention |
Primary outcome
Hot Flash Frequency
Time frame: 6 Weeks and 12 Weeks
The Hot Flash Symptoms Diary was used to measure hot flash frequency. Participants recorded their hot flashes over seven days by daily frequency and severity. This instrument provides a measure of hot flash frequency and hot flash score (product of frequency x severity).
Hot Flash Score
Time frame: 6 Weeks and 12 Weeks
Hot Flash Score is a product of frequency of hot flashes × severity of hot flashes, which could range from 0 (best possible outcome) to infinity (worst possible outcome). Hot flash frequency and hot flash severity were obtained using the Hot Flash Symptoms Diary. Participants recorded their daily hot flashes marking each hot flash (frequency) and rating the severity of each as mild (1), moderate (2), severe (3), and very severe (4). The values presented represent the average of daily hot flash scores.
Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame: 6 Weeks and 12 Weeks
This questionnaire is used to measure the effects of hot flashes on women as they go about their daily activities. Answers on the scale can range 0 (Do Not Interfere) to 10 (Completely Interfere). The total score was computed by averaging the subjective ratings over the 10 items. A lower score indicates better outcome.
2 secondary outcomes
Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture
Time frame: 6 Weeks and 12 Weeks
Pittsburg Sleep Quality Index (PSQI)
Time frame: 6 Weeks and 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34403019Roberts RL, Rhodes JR, Elkins GR. Effect of Hypnosis on Anxiety: Results from a Randomized Controlled Trial with Women in Postmenopause. J Clin Psychol Med Settings. 2021 Dec;28(4):868-881. doi: 10.1007/s10880-021-09810-3. Epub 2021 Aug 17.
- Derived from this study: PubMed 21989181Elkins GR, Fisher WI, Johnson AK. Hypnosis for hot flashes among postmenopausal women study: a study protocol of an ongoing randomized clinical trial. BMC Complement Altern Med. 2011 Oct 11;11:92. doi: 10.1186/1472-6882-11-92.
- Individual participant dataSharing planned: No
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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 R Elkins, Ph.D. principal investigator
Baylor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and Structured attention in people with Hot Flashes, run by Baylor University 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 8 inclusion and 4 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 16 Aug 2016. 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. Some participants in this study may receive a placebo. 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 17 Sep 2015). 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 Frequency (time frame: 6 Weeks and 12 Weeks). The study lists 3 primary outcomes in all. 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 NCT01293695, which also lists 2 linked publications.
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 16 Aug 2016.