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The Effect of Relaxation and Stretching Exercises on Pain and Quality of Life in Women With Primary Dysmenorrhea

Sponsor
Yeditepe University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05960695
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
3
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aimed to examine the effect of stretching and relaxation exercises on pain and quality of life in women with primary dysmenorrhea.

Condition or Disease Intervention/Treatment Phase
  • Other: Stretching
  • Other: Relaxation
 N/A

Detailed Description

While dysmenorrhea is a frequent gynecologic condition that affects women of reproductive age, young women are generally unaware of it. Dysmenorrhea is divided into two main types based on its pathophysiology:

  • Primary dysmenorrhea (PD), is menstrual discomfort coupled with regular ovulatory cycles and a defined physiological explanation. Adolescents and young adults are the most affected.

  • Secondary dysmenorrhea (SD), is defined as menstruation discomfort caused by a disease (endometriosis, fibroids, adenomyosis, pelvic adhesions, endometrial polyps, pelvic inflammatory disease) or the use of an intrauterine contraceptive device.

Dysmenorrhea is a type of persistent, cyclic pelvic pain that can be accompanied by nausea, vomiting, diarrhea, headache, exhaustion, back pain, and dizziness. In studies conducted on university students in Turkey in 2009 and 2010, 87.7% and 72.7% (respectively) of the students reported that they had pain during the menstrual period.

The release of prostaglandins into the uterine tissue is assumed to be the cause of dysmenorrhea. As a result, nonsteroidal anti-inflammatory drugs (NSAIDs) are the usual first-line treatment for dysmenorrhea. Oral contraceptives, acupuncture, acupressure, yoga, and vitamin B1 are among the additional treatments that have been suggested.

It has been suggested that exercise can help with dysmenorrhea. Physical exercise has been suggested as a medical treatment for the treatment of dysmenorrhea and related symptoms by several writers. Billig was one of the first to advocate for exercise as a treatment for dysmenorrhea; he devised a set of stretching exercises and found a reduction in dysmenorrheic symptoms.

H1: There is a significant difference in pain and quality of life in the group with stretching and relaxation exercises compared to the group with stretching exercises.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The volunteers who met the inclusion criteria were divided into 2 groups. The patients have informed about 2 different groups, but they were not told which of them. Stretching exercises were taught regardless of which group the patients were in. In addition, relaxation exercises were taught to the patients in the stretching+relaxation group.The volunteers who met the inclusion criteria were divided into 2 groups. The patients have informed about 2 different groups, but they were not told which of them. Stretching exercises were taught regardless of which group the patients were in. In addition, relaxation exercises were taught to the patients in the stretching+relaxation group.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Relaxation and Stretching Exercises on Pain and Quality of Life in Women With Primary Dysmenorrhea
Actual Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Jul 20, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: The Experimental Group

The experimental group will be given both stretching and relaxation exercises. Among the stretching exercises, iliopsoas, adductor, and hamstring stretches will be taught. Deep breathing exercises will be taught as relaxation exercises. Participants will repeat the stretches 3 times a week with 3 repetitions of each stretch for 20 seconds.

Other: Stretching
Among the stretching exercises, iliopsoas, adductor, and hamstring stretches will be taught. Participants will repeat the stretches 3 times a week with 3 repetitions of each stretch for 20 seconds. The exercises will be done online by the physiotherapist. The experimental group will be given both stretching and relaxation exercises. The Control group will be given only stretching exercises.

Other: Relaxation
Diaphragmatic breathing will be taught as a relaxation exercise. The experimental group will be given both stretching and relaxation exercises. The Control group will be given only stretching exercises.
Active Comparator: The Control group

The Control group will be given only stretching exercises. Among the stretching exercises, iliopsoas, adductor, and hamstring stretches will be taught. Participants will repeat the stretches 3 times a week with 3 repetitions of each stretch for 20 seconds.

Other: Stretching
Among the stretching exercises, iliopsoas, adductor, and hamstring stretches will be taught. Participants will repeat the stretches 3 times a week with 3 repetitions of each stretch for 20 seconds. The exercises will be done online by the physiotherapist. The experimental group will be given both stretching and relaxation exercises. The Control group will be given only stretching exercises.

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale [4 weeks]

    Participants will be evaluated their menstrual pain levels on the Visual Analogue Scale between 0 and 10.

  2. The Menstruation Symptom Questionnaire [4 weeks]

    Participants will rate their menstrual distress using the Menstrual Symptom Scale. The minimum score on this scale is 22, while the maximum score is 110. We can see that the lower the score in the questionnaire, the fewer problems the person has during the menstrual period.

  3. Short Form 12 Health Survey [4 weeks]

    Participants will be evaluated their health-related quality of life using the Short Form 12 Health Survey. It is seen that the higher the score in the questionnaire, the higher the quality of life of the person.

  4. Measurement with Algometer [4 weeks]

    Algometer measures the pain threshold, and in the study, it will be checked whether the pain thresholds changed with the exercises performed by the participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • participants in the study voluntarily.

  • participants in ages between 18-25 years of age.

  • participants have a sedentary lifestyle.

  • participant's pain intensity of more than 40 mm during the menstrual period according to the VAS.

Exclusion Criteria:

  • using regular drugs like NSAIDs

  • presence of SD

  • having an irregular menstrual cycle

  • presence of chronic disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yeditepe University Istanbul Ataşehir/İstanbul Turkey 34755

Sponsors and Collaborators

  • Yeditepe University

Investigators

  • Principal Investigator: Pelin Zöhre, Pt, Yeditepe University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Yeditepe University
ClinicalTrials.gov Identifier:
NCT05960695
Other Study ID Numbers:
  • Pyeditepe
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yeditepe University
Primary Dysmenorrhea
Pain
Exercise
Stretching
Additional relevant MeSH terms:
Dysmenorrhea

Study Results

No Results Posted as of Jul 27, 2023