N/A
N=187
Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT01293695 ↗Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Hot Flash Frequency — 27.19; 68.26; 19.44; 62.32 hot flashes per week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypnosis (Behavioral); Structured attention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Baylor University
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hot Flash Frequency |
27.19; 68.26; 19.44; 62.32 | — |
| PRIMARY Hot Flash Score |
6.71; 21.03; 4.61; 19.41 | — |
| PRIMARY Hot Flash Related Daily Interference Scale (HFRDIS) |
1.85; 4.71; 1.05; 4.43 | — |
| SECONDARY Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture |
6.15; 9.48; 4.49; 7.97 | — |
| SECONDARY Pittsburg Sleep Quality Index (PSQI) |
6.10; 10.85; 5.42; 10.66 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01293695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.