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Clinical Trials/NCT05836454
NCT05836454CompletedNot Applicable

The Effect of Progressive Muscle Relaxation Technique and Myofascial Release Technique on Premenstrual Symptoms, Blood Circulation, and Quality of Life in Women With Premenstrual Syndrome: a Single-blind Randomized Controlled Study

Eastern Mediterranean University1 site in 1 country94 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
94
Locations
1
Primary Endpoint
Change from Baseline Blood Flow Rate at Two Menstrual Cycle

Study Overview

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.

Detailed Description

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. The study planned as a single-blind randomized controlled trial. The volunteers who were invited to the study and signed the voluntary consent form will be randomized via random allocation software to divided into 3 groups. 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 will be done in the first 3 days of the first cycle, after first treatment acute assessment will be done. Post-treatment evaluation will be done in the first 3 days of the 3rd cycle after treatment for two cycles. Follow-up evaluation will be done in the first 3 days of the fifth cycle, two cycles after the post-treatment evaluation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Evaluations will be made by another physical therapist who is blinded to the groups.

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

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.

Intervention: Progressive Muscle Relaxation Group: (Other)

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.

Intervention: Myofascial Release Technique Group (Other)

Control Group

No Intervention

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

Outcomes

Primary Outcomes

Change from Baseline Blood Flow Rate at Two Menstrual Cycle

Time Frame: Baseline and 8 weeks

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.

Follow- up Evaluation Blood Flow Rate

Time Frame: 8 weeks through study completion

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.

Secondary Outcomes

  • Follow-up Evaluation Pain Severity at Two Menstrual Cycle(8 weeks through study completion)
  • Follow-up Evaluation Health-related Quality of Life(8 weeks through study completion)
  • Follow-up Evaluation Pain Threshold(8 weeks through study completion)
  • Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle(Baseline and 8 weeks)
  • Follow-up Evaluation Premenstrual Syndrome(8 weeks through study completion)
  • Change from Baseline Pain Threshold at Two Menstrual Cycle(Baseline and 8 weeks)
  • Change From Baseline Health-related Quality of Life at Two Menstrual Cycle(Baseline and 8 weeks)
  • Change from Baseline Pain Severity at Two Menstrual Cycle(Baseline and 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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