Primary DysmenorrheaNCT05960695
The Effect of Relaxation and Stretching Exercises on Pain and Quality of Life in Women With Primary Dysmenorrhea
A study testing Stretching and Relaxation in people with Primary Dysmenorrhea, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to examine the effect of stretching and relaxation exercises on pain and quality of life in women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Stretching and Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- using regular drugs like NSAIDs
- presence of SD
- having an irregular menstrual cycle
- presence of chronic disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeditepe University
Istanbul, Ataşehir/İstanbul, 34755
About this study
The study aimed to examine the effect of stretching and relaxation exercises on pain and quality of life in women with primary dysmenorrhea.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Stretching, Relaxation
- Keywords
- Primary Dysmenorrhea, Pain, Exercise, Stretching
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StretchingOther
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.
RelaxationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The Experimental Group | Experimental | 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. Receives: Other: Stretching; Other: Relaxation |
| The Control group | Active comparator | 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. Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Participants will be evaluated their menstrual pain levels on the Visual Analogue Scale between 0 and 10.
Measured: 4 weeks
The Menstruation Symptom Questionnaire
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.
Measured: 4 weeks
Short Form 12 Health Survey
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.
Measured: 4 weeks
Measurement with Algometer
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start30 May 2023
- Primary completion20 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pelin Zöhre, Pt, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960695
- Sponsor's protocol ID
- Pyeditepe
- Status last verified
- Sep 2025
- First submitted
- 26 May 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33030880Lopez-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.
PubMed 34360122Proctor 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.
PubMed 16690671Dorn 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.
PubMed 19237109Petruzzello 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.
PubMed 1828608Ameade 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.
PubMed 29433488Bernardi 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.
PubMed 28944048Kamel 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.
PubMed 28533696Burnett 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.
PubMed 28625286Doty 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.
PubMed 17060018Ryan SA. The Treatment of Dysmenorrhea. Pediatr Clin North Am. 2017 Apr;64(2):331-342. doi: 10.1016/j.pcl.2016.11.004.
PubMed 28292449Granot 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.
PubMed 11530120Tu 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.
PubMed 20705214French L. Dysmenorrhea in adolescents: diagnosis and treatment. Paediatr Drugs. 2008;10(1):1-7. doi: 10.2165/00148581-200810010-00001.
PubMed 18162003Yu 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.
PubMed 25325520
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxation and Stretching Exercises on Pain and Quality of Life in Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05960695
- Acronym / sponsor ID
- Pyeditepe
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Pain, Exercise, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to examine the effect of stretching and relaxation exercises on pain and quality of life in women with primary dysmenorrhea.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Experimental Group | Experimental | Other: Stretching, Other: RelaxationThe 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. |
| The Control group | Active comparator | Other: StretchingThe 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- using regular drugs like NSAIDs
- presence of SD
- having an irregular menstrual cycle
- presence of chronic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StretchingAmong 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 | The Control group, The Experimental Group |
| RelaxationDiaphragmatic 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. | Other | The Experimental Group |
Primary outcome
Visual Analogue Scale
Time frame: 4 weeks
Participants will be evaluated their menstrual pain levels on the Visual Analogue Scale between 0 and 10.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 33030880Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.
- Background: PubMed 34360122Lopez-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.
- Background: PubMed 16690671Proctor 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.
- Background: PubMed 19237109Dorn 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.
- Background: PubMed 1828608Petruzzello 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.
- Background: PubMed 29433488Ameade 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.
- Background: PubMed 28944048Bernardi 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.
- Background: PubMed 28533696Kamel 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.
- Background: PubMed 28625286Burnett 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.
- Background: PubMed 17060018Doty 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.
- Background: PubMed 28292449Ryan SA. The Treatment of Dysmenorrhea. Pediatr Clin North Am. 2017 Apr;64(2):331-342. doi: 10.1016/j.pcl.2016.11.004.
- Background: PubMed 11530120Granot 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.
- Health definition according to World Health OrganizationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pelin Zöhre, Pt principal investigator
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching and Relaxation in people with Primary Dysmenorrhea, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05960695, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.