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Effects of Connective Tissue Manipulation on Menopausal Symptoms

NCT05293860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

  • Menopause Syndrome

Interventions

OTHER

Connective tissue manipulation

Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group.

OTHER

Superficial massage with the head of the therapeutic ultrasound device

Superficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group.

Sponsors & Collaborators

  • Hitit University

    collaborator OTHER

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Serap Özgül, PhD · Hacettepe University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2023-04-26
Completion
2023-04-26

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293860 on ClinicalTrials.gov