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Therapeutic Effect of Laser Acupuncture on Insomnia in Perimenopausal Women

Taipei Veterans General Hospital, Taiwan · 2019
ClinicalTrials.gov · Datasets · License: Public Domain · 2019
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insomniamenopausena
According to previous studies, the quality of subjective sleep in women is generally worse than that of men. Although studies have shown that menopausal women who use hormone therapy can improve sleep disorders, the limited benefits of hormone therapy are reported, the duration of treatment and efficacy required is uncertain. The suspicions of the safety of hormone therapy have deterred many menopausal women. Systematic review and meta-analysis show that acupuncture and related therapies (including electro-acupuncture, ear needle, body acupoint massage and ear acupoint massage, etc.) used in the study of insomnia treatment have a significant therapeutic effect. However, for the reason that most of them are invasive treatments, patients receiving such treatment are often afraid and hesitated. This study will apply the low-energy laser acupuncture treatment trials to menopausal women with insomnia. Sixty perimenopausal female volunteer subjects with 45-60 years of age who have been assessed and screened for sleep disorders will be recruited and participate in this experiment. After completing the basic data and various related scales, the subjects will undergo a double-blind, randomly allocated and controlled clinical trials. The experimental procedure is that the subjects will be placed in a soundproof, lying on a comfortable bed. After the instruments setting ready, subject receives the monitoring of 5-minute heart rate variability (HRV) measurements before and after the near-infrared laser acupuncture (10mWx10) treatment, a total of 30 minutes experimental process. The results of the analysis will be based on the Pittsburgh Sleep Quality index (PSQI) questionnaire, the Insomnia Severe Index scale (ISI) data as the main assessment results for analysis. The Menopause Rating Scale, (MRS), the Beck Depression Inventory Index scale (BDI-II) and the signal measurements of heart rate variability will be analyzed as secondary assessment grounds. Data of the questionnaires
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