Effects of Connective Tissue Manipulation on Menopausal Symptoms

Menopause Syndrome Clinical Trial

Official title: Effects of Connective Tissue Manipulation on Menopausal Symptoms

Status Completed

Clinical Trial Summary

Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. This process involves some bothersome physical and psychological climacteric symptoms. The most common symptoms are vasomotor symptoms, psychological symptoms and sleep disturbances. The aim of this study is to investigate the effects of Connective Tissue Manipulation (CTM) on vasomotor symptoms, psychological symptoms, sleep quality and quality of life in the postmenopausal period in a randomized placebo-controlled study design. For this purpose, 58 postmenopausal women who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms; CTM or placebo control. The participants in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks, whereas the participant in the placebo control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcomes are frequency of vasomotor symptoms and vasomotor symptom score and they will be evaluated by daily diaries. Secondary outcomes are general severity of menopausal symptoms, psychological status, severity and effect of insomnia and quality of life associated with menopause. These outcomes will be assessed by questionnaires; "Menopausal Symptoms Rating Scale", "Depression-Anxiety-Stress 21 Scale", "Insomnia Severity Index", and "Menopause-Specific Quality of Life Scale". All outcome measurements will be evaluated at baseline and after the intervention period. Then, the results will be compared within groups and between two study groups.

Clinical Trial Description

Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. It is part of the natural aging process and occurs by declining the estrogen secretion from the ovaries. This process involves some bothersome physical and psychological climacteric symptoms that negatively influence the women's well-being and quality of life. The most common symptoms are vasomotor symptoms (hot flashes, sweating, night sweats), psychological symptoms (anxiety, depression, stress) and insomnia. Although hormonal and non-hormonal pharmacological methods are widely used effective approaches to control these symptoms, they have some risks or adverse side effects. For this reason, women tend to alternative therapies and complementary medicine methods to improve climacteric symptoms and their quality of life. Connective tissue manipulation (CTM) is a manual reflex therapy method which aims to restore the balance between the sympathetic and parasympathetic components of the autonomic nervous system. It is characterised by special type of manual stroke which is applied to the connective tissue. These stretching maneuvers are applied to areas called "reflex zones", and create local, segmental and general therapeutic effects in the body. The aim of this study is to investigate the effects of CTM on vasomotor symptoms, psychological symptoms, sleep quality and quality of life in the postmenopausal period in a randomized placebo controlled study design. For this purpose, 58 postmenopausal women ages between 45 to 65 who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms, CTM or placebo control. The women in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks. On the other hand, the women in the placebo control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcomes are frequency of vasomotor symptoms and vasomotor symptom score and they will be evaluated by daily diaries. Secondary outcomes are general severity of menopausal symptoms, psychological status, severity and effect of insomnia and quality of life associated with menopause. These outcomes will be assessed by questionnaires; "Menopausal Symptoms Rating Scale", "Depression-Anxiety-Stress 21 Scale", "Insomnia Severity Index", and "Menopause-Specific Quality of Life Scale". State anxiety, mobility and flexibility of connective tissue, autonomic functions and treatment satisfaction will also be evaluated in the study. The diaries will be filled out for one week (7 days each); at the baseline and just after the completion of the study. All other outcome measurements will be performed before and immediately after the study is completed. The results will be compared within groups and between two study groups. ;

Related Conditions & MeSH terms

• Menopause Syndrome

• NCT number: NCT05293860
• Study type: Interventional
• Source: Hacettepe University
• Status: Completed
• Phase: N/A
• Start date: April 15, 2022
• Completion date: April 26, 2023