- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05960695
The Effect of Relaxation and Stretching Exercises on Pain and Quality of Life in Women With Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ataşehir/İstanbul
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Istanbul, Ataşehir/İstanbul, Turkey (Türkiye), 34755
- Yeditepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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. |
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.
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 4 weeks
|
Participants will be evaluated their menstrual pain levels on the Visual Analogue Scale between 0 and 10.
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4 weeks
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The Menstruation Symptom Questionnaire
Time Frame: 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.
|
4 weeks
|
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Short Form 12 Health Survey
Time Frame: 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 weeks
|
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Measurement with Algometer
Time Frame: 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.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pelin Zöhre, Pt, Yeditepe University
Publications and helpful links
General Publications
- Bernardi M, Lazzeri L, Perelli F, Reis FM, Petraglia F. Dysmenorrhea and related disorders. F1000Res. 2017 Sep 5;6:1645. doi: 10.12688/f1000research.11682.1. eCollection 2017.
- Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.
- Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2015 Jul 30;2015(7):CD001751. doi: 10.1002/14651858.CD001751.pub3.
- Dorn LD, Negriff S, Huang B, Pabst S, Hillman J, Braverman P, Susman EJ. Menstrual symptoms in adolescent girls: association with smoking, depressive symptoms, and anxiety. J Adolesc Health. 2009 Mar;44(3):237-43. doi: 10.1016/j.jadohealth.2008.07.018. Epub 2008 Oct 29.
- Doty E, Attaran M. Managing primary dysmenorrhea. J Pediatr Adolesc Gynecol. 2006 Oct;19(5):341-4. doi: 10.1016/j.jpag.2006.06.005. No abstract available.
- Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
- Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.
- Petruzzello SJ, Landers DM, Hatfield BD, Kubitz KA, Salazar W. A meta-analysis on the anxiety-reducing effects of acute and chronic exercise. Outcomes and mechanisms. Sports Med. 1991 Mar;11(3):143-82. doi: 10.2165/00007256-199111030-00002.
- Ameade EPK, Amalba A, Mohammed BS. Prevalence of dysmenorrhea among University students in Northern Ghana; its impact and management strategies. BMC Womens Health. 2018 Feb 13;18(1):39. doi: 10.1186/s12905-018-0532-1.
- Kamel DM, Tantawy SA, Abdelsamea GA. Experience of dysmenorrhea among a group of physical therapy students from Cairo University: an exploratory study. J Pain Res. 2017 May 9;10:1079-1085. doi: 10.2147/JPR.S132544. eCollection 2017.
- Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.
- Ryan SA. The Treatment of Dysmenorrhea. Pediatr Clin North Am. 2017 Apr;64(2):331-342. doi: 10.1016/j.pcl.2016.11.004.
- Granot M, Yarnitsky D, Itskovitz-Eldor J, Granovsky Y, Peer E, Zimmer EZ. Pain perception in women with dysmenorrhea. Obstet Gynecol. 2001 Sep;98(3):407-11. doi: 10.1016/s0029-7844(01)01465-x.
- Tu CH, Niddam DM, Chao HT, Chen LF, Chen YS, Wu YT, Yeh TC, Lirng JF, Hsieh JC. Brain morphological changes associated with cyclic menstrual pain. Pain. 2010 Sep;150(3):462-468. doi: 10.1016/j.pain.2010.05.026.
- French L. Dysmenorrhea in adolescents: diagnosis and treatment. Paediatr Drugs. 2008;10(1):1-7. doi: 10.2165/00148581-200810010-00001.
- Yu A. Complementary and alternative treatments for primary dysmenorrhea in adolescents. Nurse Pract. 2014 Nov 16;39(11):1-12. doi: 10.1097/01.NPR.0000454984.19413.28.
- Xu K, Chen L, Fu L, Xu S, Fan H, Gao Q, Xu Y, Wang W. Stressful Parental-Bonding Exaggerates the Functional and Emotional Disturbances of Primary Dysmenorrhea. Int J Behav Med. 2016 Aug;23(4):458-63. doi: 10.1007/s12529-015-9504-0.
- ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.
- Morrow C, Naumburg EH. Dysmenorrhea. Prim Care. 2009 Mar;36(1):19-32, vii. doi: 10.1016/j.pop.2008.10.004.
- Pattanittum P, Kunyanone N, Brown J, Sangkomkamhang US, Barnes J, Seyfoddin V, Marjoribanks J. Dietary supplements for dysmenorrhoea. Cochrane Database Syst Rev. 2016 Mar 22;3(3):CD002124. doi: 10.1002/14651858.CD002124.pub2.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pyeditepe
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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