Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01293695

Enrollment

187

Registered

2011-02-11

Start date

2007-09-30

Completion date

2014-03-31

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

hot flashes, post menopausal women, skin conductance monitors, hypnosis, hypnotizability

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.

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.

Interventions

BEHAVIORALHypnosis

Hypnosis relaxation in five weekly sessions

OTHERStructured attention

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Postmenopausal as defined by: 1. no menstrual period in the past 12 months; 2. no menstrual period in the past 6 months and a medically documented history of FSH level greater than 40; or 3. 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

Design outcomes

Primary

Measure	Time frame	Description
Hot Flash Frequency	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	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)	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.

Secondary

Measure	Time frame	Description
Sternal Skin Conductance Monitor Used to Physiologically Measure Skin Moisture	6 Weeks and 12 Weeks	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.
Pittsburg Sleep Quality Index (PSQI)	6 Weeks and 12 Weeks	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.

Countries

United States

Participant flow

Recruitment details

Recruitment occurred from December, 2008 to April, 2012. Participants were recruited by using fliers, mailings, billboard advertising and word-of-mouth. Local clinics were also visited and informative materials were left with physicians.

Participants by arm

Arm	Count
Hypnosis Receives 5 weeks of hypnotic relaxation therapy (HRT) Hypnosis: Hypnosis relaxation in five weekly sessions	93
Structured Attention Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis	94
Total	187

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	8	6
Overall Study	Withdrawal by Subject	7	1

Baseline characteristics

Characteristic	Structured Attention	Total	Hypnosis
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	7 Participants	16 Participants	9 Participants
Age, Categorical Between 18 and 65 years	87 Participants	171 Participants	84 Participants
Biolog Hot Flash Monitor (physiological measure)	8.85 micro Siemens STANDARD_DEVIATION 0.75	9.63 micro Siemens STANDARD_DEVIATION 0.88	10.41 micro Siemens STANDARD_DEVIATION 1
Education Associate Degree	12 participants	24 participants	12 participants
Education Bachelor's Degree	22 participants	36 participants	14 participants
Education College, non degree	20 participants	40 participants	20 participants
Education Graduate Degree	8 participants	19 participants	11 participants
Education High School Diploma	26 participants	52 participants	26 participants
Education Less than High School	6 participants	16 participants	10 participants
Hot Flash Frequency	75.21 hot flashes per week STANDARD_DEVIATION 3.11	75.24 hot flashes per week STANDARD_DEVIATION 2.97	75.26 hot flashes per week STANDARD_DEVIATION 2.82
Hot Flash Related Daily Interference Scale (HFRDIS)	5.75 units on a scale STANDARD_DEVIATION 0.24	5.81 units on a scale STANDARD_DEVIATION 24	5.87 units on a scale STANDARD_DEVIATION 0.23
Hot Flash Score	22.94 units on a scale STANDARD_DEVIATION 1.23	23.69 units on a scale STANDARD_DEVIATION 1.13	24.43 units on a scale STANDARD_DEVIATION 1.02
Marital Status Divorced	10 participants	18 participants	8 participants
Marital Status Married	65 participants	122 participants	57 participants
Marital Status Separated	5 participants	10 participants	5 participants
Marital Status Single	12 participants	31 participants	19 participants
Marital Status Widowed	2 participants	6 participants	4 participants
Pittsburg Sleep Quality Index (PSQI)	11.89 units on a scale STANDARD_DEVIATION 0.48	11.79 units on a scale STANDARD_DEVIATION 0.52	11.69 units on a scale STANDARD_DEVIATION 0.56
Race/Ethnicity, Customized African American	11 participants	31 participants	20 participants
Race/Ethnicity, Customized American Indian	3 participants	5 participants	2 participants
Race/Ethnicity, Customized Asian	0 participants	1 participants	1 participants
Race/Ethnicity, Customized Hispanic	6 participants	12 participants	6 participants
Race/Ethnicity, Customized White	74 participants	138 participants	64 participants
Region of Enrollment United States	94 participants	187 participants	93 participants
Sex: Female, Male Female	94 Participants	187 Participants	93 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	13 / 93	12 / 94
serious Total, serious adverse events	0 / 93	0 / 94

Outcome results

Primary

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).