NCT01293695

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 17, 2015

Completed
Last Updated

August 16, 2016

Status Verified

July 1, 2016

Enrollment Period

6.5 years

First QC Date

February 10, 2011

Results QC Date

January 28, 2015

Last Update Submit

July 18, 2016

Conditions

Hot Flashes

Keywords

hot flashespost menopausal womenskin conductance monitorshypnosishypnotizability

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    6 Weeks and 12 Weeks

Secondary Outcomes (2)

  • Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture

    6 Weeks and 12 Weeks

  • Pittsburg Sleep Quality Index (PSQI)

    6 Weeks and 12 Weeks

Study Arms (2)

Hypnosis

ACTIVE COMPARATOR

Receives 5 weeks of hypnotic relaxation therapy

Behavioral: Hypnosis

Structured Attention

PLACEBO COMPARATOR

Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy

Other: Structured attention

Interventions

HypnosisBEHAVIORAL

Hypnosis relaxation in five weekly sessions

Also known as: Hypnotic relaxation therapy, Hypnosis relaxation, Hypnotic intervention, Hypnosis intervention
Hypnosis
Structured attentionOTHER

Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy

Also known as: Placebo Comparator
Structured Attention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mind-Body Medicine Research Lab-Baylor University

Waco, Texas, 76798, United States

Location

Related Publications (2)

  • 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.

    PMID: 34403019DERIVED

  • Elkins 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.

    PMID: 21989181DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

limitations: results may not generalize to all women with hot flashes * some hot flashes occur at other times than during the climacteric * self-selection bias (predispositions to mind-body therapy) * population was largely caucasian

Results Point of Contact

Title
Dr. Gary Elkins, Director of the Mind-Body Medicine Research Laboratory
Organization
Baylor University
gary_elkins@baylor.edu
254-296-0643

Study Officials

  • Gary R Elkins, Ph.D.

    Baylor University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

September 1, 2007

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 16, 2016

Results First Posted

September 17, 2015

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)