NCT05293860

Effects of Connective Tissue Manipulation on Menopausal Symptoms

Completed NA Last updated 25 September 2024

What this trial tests

NA trial testing Connective tissue manipulation in Menopause Syndrome in 52 participants. Completed in 26 April 2023.

Timeline

15 April 2022

Primary endpoint
26 April 2023

26 April 2023

Quick facts

Lead sponsor	Hacettepe University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	52
Start date	15 April 2022
Primary completion	26 April 2023
Estimated completion	26 April 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Connective tissue manipulation
• Superficial massage with the head of the therapeutic ultrasound device

Conditions studied

• Menopause Syndrome — all drugs for Menopause Syndrome →

Sponsor

Hacettepe University

Who can join

Adults 45 to 65, female only, with Menopause Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of connective tissue massage on physical and emotional symptoms, insomnia, and quality of life in postmenopausal women: A randomized, sham-controlled trial.
   Albayrak G, Çağlıyan Türk A, Özgül S. · · 2025 · cited 2× · PMID 39522476 · DOI 10.1016/j.maturitas.2024.108149