NCT05836454

Brief Summary

The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. There are tree groups in the study. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment and post- treatment assessment will be done. Follow-up evaluation will be done on the fifth cycle, two cycles after the post-treatment evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

March 14, 2023

Last Update Submit

July 13, 2025

Conditions

Keywords

myofascial releasing techniqueprogressive relaxation techniqueblood flow velocity

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Blood Flow Rate at Two Menstrual Cycle

    Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.

    Baseline and 8 weeks

  • Follow- up Evaluation Blood Flow Rate

    Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.

    8 weeks through study completion

Secondary Outcomes (8)

  • Change from Baseline Pain Severity at Two Menstrual Cycle

    Baseline and 8 weeks

  • Follow-up Evaluation Pain Severity at Two Menstrual Cycle

    8 weeks through study completion

  • Change from Baseline Pain Threshold at Two Menstrual Cycle

    Baseline and 8 weeks

  • Follow-up Evaluation Pain Threshold

    8 weeks through study completion

  • Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle

    Baseline and 8 weeks

  • +3 more secondary outcomes

Study Arms (3)

Progressive Muscle Relaxation Group:

EXPERIMENTAL

Progressive Muscle Relaxation technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles.

Other: Progressive Muscle Relaxation Group:

Myofascial Release Technique Group

EXPERIMENTAL

Myofascial Release Technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles.

Other: Myofascial Release Technique Group

Control Group

NO INTERVENTION

The control group will be asked to continue their normal lives.

Interventions

Progressive muscle relaxation is a relaxation technique that involves regular and sequential contraction and relaxation of muscles until the whole body is relaxed.

Progressive Muscle Relaxation Group:

It is a physiotherapy technique based on soft tissue mobilization. All enveloping fascia sale prices are positive for mobility, a user used for adhesions and pain.

Myofascial Release Technique Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain score of 4 cm or more according to the Visual Analogue Scale.
  • Having a regular menstrual cycle for 12 months (24-35 days).
  • According to the International Physical Activity Questionnaire-Short Form (IPAQ-SF), the weekly Metabolic Equivalent of Task (MET) value is below 600 MET-min/week.

You may not qualify if:

  • Those who have undergone surgery in the last 6 months,
  • Those who use cigarettes and alcohol,
  • Those who are pregnant,
  • Those with urinary, genital, gastrointestinal disorders,
  • Those who have had hysterectomy surgery will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, Cyprus

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Çisel Demiralp, Msc

    Eastern Meditteranean Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluations will be made by another physical therapist who is blinded to the groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single Blind Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

May 1, 2023

Study Start

September 1, 2022

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 16, 2025

Record last verified: 2025-05

Locations