Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 1:20 AM
Study NCT ID:
NCT05293860
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2022-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Connective Tissue Manipulation on Menopausal Symptoms
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
Effects of Connective Tissue Manipulation on Menopausal Symptoms
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
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 sham 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 sham 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 outcome is menopausal symptom severity and will be assessed by the \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires; \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\". 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.
The aim of this study is to investigate the effects of CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
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 sham 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 sham 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 outcome is menopausal symptom severity and will be assessed by the \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires; \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\". 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.
Detailed 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 postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
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 sham 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 sham 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 outcome is menopausal symptom severity and it will be evaluated by \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\".
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.
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 postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.
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 sham 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 sham 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 outcome is menopausal symptom severity and it will be evaluated by \"Menopause Rating Scale\". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires \"Menopause-Specific Quality of Life Scale\", \"Depression-Anxiety-Stress 21 Scale\" and \"Insomnia Severity Index\".
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: