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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05836454
Other study ID # PMSBloodFlow
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date September 30, 2023

Study information

Verified date June 2023
Source Eastern Mediterranean University
Contact Çisel Demiralp, Msc
Phone 05338412953
Email ptciseldemiralp@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 94
Est. completion date September 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 30 Years
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
Cyprus Eastern Mediterranean University Famagusta

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change from Baseline Pain Severity at Two Menstrual Cycle 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. Baseline and 8 weeks
Secondary Follow-up Evaluation Pain Severity at Two Menstrual Cycle 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. 8 weeks through study completion
Secondary Change from Baseline Pain Threshold at Two Menstrual Cycle 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. Baseline and 8 weeks
Secondary Follow-up Evaluation Pain Threshold 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. 8 weeks through study completion
Secondary Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail. Baseline and 8 weeks
Secondary Follow-up Evaluation Premenstrual Syndrome It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail. 8 weeks through study completion
Secondary Change From Baseline Health-related Quality of Life at Two Menstrual Cycle 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. Baseline and 8 weeks
Secondary Follow-up Evaluation Health-related Quality of Life 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 weeks through study completion
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