Self-Administered Hypnosis Treatment for the Management of Hot Flashes in Women: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Hot Flash Daily Diary
研究概览
简要总结
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.
详细描述
This randomized, two arm clinical trial will evaluate the efficacy of self-administered hypnosis for the treatment of hot flashes in postmenopausal women using a 1:1 randomization schedule.
Primary Objective
To evaluate the efficacy of the self-administered hypnosis intervention for hot flashes compared to the self-administered white noise hypnosis.
Hypothesis 1: Self-administered hypnosis will significantly decrease vasomotor symptoms (hot flash score of frequency and severity) compared to the self-administered white noise hypnosis at 6 weeks.
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Self-Administered Hypnosis
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.
干预措施: Self-Administered Hypnosis (Behavioral)
Self-Administered White Noise Hypnosis
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.
干预措施: Self-Administered White Noise Hypnosis (Behavioral)
结局指标
主要结局
Hot Flash Daily Diary
时间窗: The hot flash daily diary was collected at baseline (week 0), endpoint (week 6) and follow-up (week 12).
Participants completed the Hot Flash Daily Diary (Sloan et al., 2001) every day for 6 weeks to measure the daily frequency and severity (mild, moderate, severe, and very severe) of hot flashes. A total hot flash score was calculated for each participant (product of frequency x severity) after severity ratings were assigned a point value as follows: * mild = 1 * moderate = 2 * severe = 3 * very severe = 4 The hot flash score was then calculated by multiplying the participants' frequency and severity ratings of hot flashes, divided by the total number of days. A lower score indicates less frequent and/or severe hot flashes.
次要结局
- Hot Flash Related Daily Interference Scale(The Hot Flash Related Daily Interference Scale was completed at Baseline (week 0), at endpoint (week 6) and at follow-up (week 12).)
- Emotional Distress Anxiety Scale(Baseline, 6 & 12 Weeks)
- Pittsburgh Sleep Quality Index(Baseline, 6, & 12 weeks.)
- Subject Global Impression of Change(The Subject Global Impressions of Change will be completed only at 6 weeks.)
- Perceived Stress Scale(Baseline, 6, & 12 weeks)
研究者
Gary R. Elkins
Director of Mind-Body Medicine Research Lab
Baylor University