Hypnosis for hot flashes among postmenopausal women study: A study protocol of an ongoing randomized clinical trial

<p>Abstract</p> <p>Background</p> <p>Hot flashes are a highly prevalent problem associated with menopause and breast cancer treatments. The recent findings from the Women's Health Initiative have important implications for the significance of a non-hormonal, mind-body intervention for hot flashes in breast cancer survivors. Women who take hormone therapy long-term may have a 1.2 to 2.0 fold increased risk of developing breast cancer. In addition, it is now known that hormone therapy with estrogen and progestin is associated with increased risk of cardiovascular disease and stroke. Currently there are limited options to hormone replacement therapy as non-hormonal pharmacological agents are associated with only modest activity and many adverse side effects. Because of this there is a need for more alternative, non-hormonal therapies. Hypnosis is a mind-body intervention that has been shown to reduce self-reported hot flashes by up to 68% among breast cancer survivors, however, the use of hypnosis for hot flashes among post-menopausal women has not been adequately explored and the efficacy of hypnosis in reducing physiologically measured hot flashes has not yet been determined.</p> <p>Methods/design</p> <p>A sample of 180 post-menopausal women will be randomly assigned to either a 5-session Hypnosis Intervention or 5-session structured-attention control with 12 week follow-up. 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. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; Hot Flash Related Daily Interference Scale), anxiety (State-Trait Anxiety Inventory; Hospital Anxiety and Depression Scale (HADS); anxiety visual analog scale (VAS rating); depression (Center for Epidemiologic Studies Depression Scale), sexual functioning (Sexual Activity Questionnaire), sleep quality (Pittsburgh Sleep Quality Index) and cortisol.</p> <p>Discussion</p> <p>This study 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.</p> <p>Trial Registration</p> <p>This clinical trial has been registered with ClinicalTrials.gov, a service of the U.S. National Institutes of Health, ClinicalTrials.gov Identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01293695">NCT01293695</a>.</p

The Lived Experience of Pregnancy as a Black Woman in America: A Descriptive Phenomenological Case Study

For more than fifty years, black women have faced more than double the U.S. average risk for both maternal mortality [1] and severe morbidity [2]. In addition, black women face two to three times the risk for preterm and low birth weight infant outcomes [3 - 7]. Poverty, barriers to healthcare access, and lifestyle choices are commonly identified factors influencing this disparity [5, 7, 8]. These stress-related factors are credible; however, half a century of studies, based on the same, have not led to improved outcomes. Large population studies indicate that such factors alone are inadequate to explain the problem [9], and the disparity persists. While individual stressors have a role in race related health disparities, particularly in pregnancy outcomes, a comprehensive explanation of the problem incorporating complex social, environmental, interpersonal factors with individual components are needed. Yet, there is a paucity of such comprehensive evidence. Specifically, there is insufficient description of the lived experience of adversity for pregnant black women

The Lived Experience of Pregnancy as a Black Woman in America: A Descriptive Phenomenological Case Study

For more than fifty years, black women have faced more than double the U.S. average risk for both maternal mortality [1] and severe morbidity [2]. In addition, black women face two to three times the risk for preterm and low birth weight infant outcomes [3 - 7]. Poverty, barriers to healthcare access, and lifestyle choices are commonly identified factors influencing this disparity [5, 7, 8]. These stress-related factors are credible; however, half a century of studies, based on the same, have not led to improved outcomes. Large population studies indicate that such factors alone are inadequate to explain the problem [9], and the disparity persists. While individual stressors have a role in race related health disparities, particularly in pregnancy outcomes, a comprehensive explanation of the problem incorporating complex social, environmental, interpersonal factors with individual components are needed. Yet, there is a paucity of such comprehensive evidence. Specifically, there is insufficient description of the lived experience of adversity for pregnant black women

A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1):trial protocol

BACKGROUND: This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats) in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested: Compared to usual care, group cognitive behavioural therapy will: 1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation. 2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation. METHODS/DESIGN: Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT) sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes. Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires) are collected six to eight weeks later and follow-up measures (questionnaires and a use of medical services measure) at six months post-randomisation. DISCUSSION: MENOS 1 is the first randomised controlled trial of cognitive behavioural therapy for hot flushes and night sweats that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by developing an evidence-based, non-medical treatment, which can be delivered by trained health professionals. TRIAL REGISTRATION: Current Controlled Trials ISRCTN1377193