Clinical trial · Interventional
A Mind-Body Intervention for Hot Flash Management
Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
NCT03572153CI-TRIAL-00090604completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hot Flashes | — | UNRESOLVED | — |
| Postmenopausal Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-Administered Hypnosis | Behavioral | — | UNRESOLVED |
| Self-Administered White Noise Hypnosis | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-Administered Hypnosis
- description
- 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.
- interventionNames
- Behavioral: Self-Administered Hypnosis
- type
- ACTIVE_COMPARATOR
- label
- Self-Administered White Noise Hypnosis
- description
- 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.
- interventionNames
- Behavioral: Self-Administered White Noise Hypnosis
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDElkins 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. PMID 41217756