CompletedNot Applicable

Effects of Connective Tissue Manipulation on Menopausal Symptoms

Turkey (Türkiye)52 participantsStarted 2022-04-15

Plain-language 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.

Who can participate

Age range

45 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between the 45 and 65 years, * Being experienced at least 3 moderate or severe hot flashes, sweating or night sweats per day for at least 3 months, * Being in the natural/spontaneous postmenopausal (amenorrhea for at least 12 months) period for less than 10 years, * Having stable vital signs (heart rate, blood pressure), * Volunteer to participate in the study, * Have signed the informed consent form. Exclusion Criteria * Neurological diseases, * Uncontrolled systemic and metabolic diseases (uncontrolled diabetes mellitus, hypertension, etc.) * History of cancer, * History of surgical menopause, * Obesity (BMI \> 35 kg/m²), * Use of any hormonal or non-hormonal treatment for vasomotor or other menopausal symptoms in the past 6 months, * Psychiatric and mental disorders that prevent the cooperation to the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Severity of menopausal symptoms

Timeframe: Change in the severity of menopausal symptoms from baseline to at the end of the 4th week.

Trial details

NCT IDNCT05293860

SponsorHacettepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-26

View on ClinicalTrials.gov More Menopause Syndrome trials