CUHK_CCT00365
2013-04-10
Prospective
N/A
Research Fund for the Control of Infectious Diseases Health and Health Services Research FundThe Food and Health Bureau, HKSAR
Division of Family Medicine and Primary Healthcare, School of Public Health and Primary Care, The Chinese University of Hong Kong
N/A
Not Applicable
Ting Gao
Room 426, School of Public Health and Primary Care
22528758
tiffanyding@cuhk.edu.hk
The Chinese University of Hong Kong
Hong Kong
Samuel Yeung Shan Wong
Room 401, School of Public Health and Primary Care
22528774
yeungshanwong@cuhk.edu.hk
The Chinese University of Hong Kong
Hong Kong
A randomized, controlled clinical trial: the effects of mindfulness-based stress reduction program on the reduction of menopausal symptoms among Chinese peri-menopausal and post-menopausal women in the community
A randomized, controlled clinical trial: the effects of mindfulness-based stress reduction program on the reduction of menopausal symptoms among Chinese peri-menopausal and post-menopausal women in the community
基層醫療中的更年期徵狀研究計畫
The Chinese University of Hong Kong
Hong Kong
Yes
2012-01-17
Joint CUHK-NTEC Clinical Research Ethics Committee
2011.561
menopausal symptoms
Other
mindfulness based stress reduction program
The program will include daily homework exercises that consist of guided (taped) or unguided awareness exercises directed at increasing moment-by-moment non-judgmental awareness of bodily sensations, thoughts and feelings, together with exercises designed to integrate the application of awareness skills into daily life. The curriculum will include training in mindfulness through (1) a body scan, the gradual moving of attention through the body from head to feet while lying on a mat on the floor, brining awareness particularly to bodily sensations; (2) sitting meditation, in which attention is brought to breathing sensations and the flow of bodily sensations, thoughts, and emotions; and (3) mindful stretching exercises, to cultivate awareness during simple stretching movement. The key themes of MBSR will include the empowerment of participants and a focus on awareness and acceptance of experience at the present moment. Participants are guided to develop a “decentered” perspective on thoughts and feelings, in which these are viewed as passing events in the mind.
NA
NA
The MBSR program will consist of two-and-a-half-hour weekly sessions for eight weeks
one session per week
The MEC will consist of an eight-week psycho-education intervention that is based on principles used in a health education intervention for middle-aged women to increase their knowledge and their self-efficacy in relation to the menopause. These sessions will include health education with respect to information about the menopause, self-help and medical treatments, discussion of expectations and beliefs about the menopause, focus on general health (reducing stress, exercise, smoking and diet.
NA
NA
The MBSR program will consist of two-and-a-half-hour weekly sessions for eight weeks
one session per week
(1) women aged 40-60,1, 6 who are peri-menopausal or early post-menopausal1 (but who are not affected by hysterectomy, oophorectomy or pregnancy). In this study, peri-menopausal status is defined as the period immediately prior to the menopause with change in menstrual pattern and irregular cycle (defined as changes in frequency compared with 12 months ago) and post-menopausal status is defined as absence of periods for at least 12 months; (2) women having a somatic symptom score of six or above on the Greene Climacteric Symptom Score; and (3) women who are willing to maintain the present exercise, dietary pattern, and dose of any soy supplements.
(1) psychiatric and medical comorbidities that are potentially life-threatening (i.e., psychosis, suicidal ideation, terminal medical illness) or conditions expected to severely limit patient participation or adherence (e.g., psychosis, current substance or alcohol abuse, dementia, pregnancy); and (2) medical conditions or medications that may affect menopausal symptoms including hot flushes (such as the presence of thyroid disease or the use of selective estrogen receptor modulator, hormone therapy, or the use of traditional Chinese medicine for the menopause). (3) Women who have previously practiced or are currently practicing meditation will be excluded from the study. Women with breast cancer are eligible as long as they have completed all the treatments for their cancer with partial or total remission for at least six months. The women will be asked to report their initiation of the use of any medications during the study, and women who use any anxiolytics or SSRIs will be asked to keep their present dosage stable and to immediately report any changes during the study period.
40
60
Female
Interventional
Randomized
simple randomization
Active
Single-blind
Investigator/research team
Parallel
Other
NA
2013-09-01
196
Complete
The primary outcome, the climacteric symptoms of the women will be assessed by the Chinese version of the GCS. The GCS consists of 21 items that are grouped into five difference domains: anxiety; depression; somatic symptoms; vasomotor symptoms; and sexual symptoms. The modified GCS would be used in this study with the addition of urogenital symptoms with three items: increased urinary frequency, urinary incontinence, and vaginal dryness which has been used previously and validated. Each symptom is scored on a four-point rating scale from 0 (not at all bothered) to 3 (extremely bothered), and the scores will be added up to show the overall severity of the climacteric symptoms. The questionnaire will be collected at baseline, immediately post, 3 months and 6 months after the intervention.
1)Stress will be measured by the Global Measure of Perceived Stress Scale (PSS).
2) Mindfulness will be measured by the Five Facet Mindfulness Questionnaire41 to evaluate whether the increase or changes in mindfulness are related to changes in the outcomes of menopausal symptoms.
3) Health related quality of life will be measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12). The SF-12 is a 12-item survey that reports health-related quality of life, including both physical and mental functioning and well-being.
All these scales will be collected at baseline, immediate post, 3 and 6 months after the intervention.
2017-10-23
ChiCTR-TRC-13003192
2013-04-28
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