Effect of Progressive Muscle Relaxation Technique and Myofascial Relaxation Technique on Premenstrual Syndrome Patients

Sponsor
Eastern Mediterranean University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05836454
Collaborator
(none)
94
1
3
12.9
7.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Progressive Muscle Relaxation Group:
  • Other: Myofascial Release Technique Group
N/A

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
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single Blind Randomized Controlled StudySingle Blind Randomized Controlled Study
Masking:
Single (Outcomes Assessor)
Masking Description:
Evaluations will be made by another physical therapist who is blinded to the groups.
Primary Purpose:
Treatment
Official Title:
Effect of Progressive Muscle Relaxation Technique and Myofascial Relaxation Technique on Blood Flow Rate, Pain, Premenstrual Symptoms, Quality of Life in Premenstrual Syndrome Patients. Single Blind Randomized Controlled Study
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Progressive Muscle Relaxation Group:

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

Experimental: Myofascial Release Technique Group

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
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.

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Blood Flow Rate at Two Menstrual Cycle [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.

  2. Follow- up Evaluation Blood Flow Rate [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 Outcome Measures

  1. Change from Baseline Pain Severity at Two Menstrual Cycle [Baseline and 8 weeks]

    It will be evaluated with the visual analog scale. Pain is determined by measuring the mark on the 10-centimeter line according to the severity of the pain. According to the Visual Analogue Scale (VAS), a score of 0 indicates no pain, and 10 indicates unbearable pain.

  2. Follow-up Evaluation Pain Severity at Two Menstrual Cycle [8 weeks through study completion]

    It will be evaluated with the visual analog scale. Pain is determined by measuring the mark on the 10-centimeter line according to the severity of the pain. According to the VAS, a score of 0 indicates no pain, and 10 indicates unbearable pain.

  3. Change from Baseline Pain Threshold at Two Menstrual Cycle [Baseline and 8 weeks]

    It will be evaluated with a digital algometer and the value on the algometer will be recorded in kg. Evaluation areas are Vastus medialis, Pectoralis major, Gluteus maximus, Gluteus medius, Iliopsoas, Lumbal paraspinal, Trapezius, Spina iliaca anterior superior (SIAS). Measurements will be made from the muscle body.

  4. Follow-up Evaluation Pain Threshold [8 weeks through study completion]

    It will be evaluated with a digital algometer and the value on the algometer will be recorded in kg. Evaluation areas are Vastus medialis, Pectoralis major, Gluteus maximus, Gluteus medius, Iliopsoas, Lumbal paraspinal, Trapezius, Spina iliaca anterior superior (SIAS). Measurements will be made from the muscle body.

  5. Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle [Baseline and 8 weeks]

    It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.

  6. Follow-up Evaluation Premenstrual Syndrome [8 weeks through study completion]

    It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.

  7. Change From Baseline Health-related Quality of Life at Two Menstrual Cycle [Baseline and 8 weeks]

    It will be evaluated with the SF-36 short form. Turkish validity and reliability study made by Kocyigit et al. In the evaluation of the scale, a score between 0-100 points can obtained from each sub-dimension, 0 points indicates that the quality of life dimension is bad and 100 points that it is good.

  8. Follow-up Evaluation Health-related Quality of Life [8 weeks through study completion]

    It will be evaluated with the SF-36 short form. Turkish validity and reliability study made by Kocyigit et al. In the evaluation of the scale, a score between 0-100 points can obtained from each sub-dimension, 0 points indicates that the quality of life dimension is bad and 100 points that it is good.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eastern Mediterranean University Famagusta Cyprus

Sponsors and Collaborators

  • Eastern Mediterranean University

Investigators

  • Principal Investigator: Çisel Demiralp, Msc, Eastern Meditteranean Univeristy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eastern Mediterranean University
ClinicalTrials.gov Identifier:
NCT05836454
Other Study ID Numbers:
  • PMSBloodFlow
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eastern Mediterranean University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023