NCT05960695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

May 26, 2023

Last Update Submit

September 10, 2025

Conditions

Keywords

Primary DysmenorrheaPainExerciseStretching

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale

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

    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.

    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.

    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.

    4 weeks

Study Arms (2)

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.

Other: StretchingOther: 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.

Other: Stretching

Interventions

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.

The Control groupThe Experimental Group

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.

The Experimental Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • using regular drugs like NSAIDs
  • presence of SD
  • having an irregular menstrual cycle
  • presence of chronic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir/İstanbul, 34755, Turkey (Türkiye)

Location

Related Publications (20)

  • 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.

    PMID: 33030880BACKGROUND
  • 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.

    PMID: 34360122BACKGROUND
  • 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.

    PMID: 16690671BACKGROUND
  • 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.

    PMID: 19237109BACKGROUND
  • 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.

    PMID: 1828608BACKGROUND
  • 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.

    PMID: 29433488BACKGROUND
  • 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.

    PMID: 28944048BACKGROUND
  • 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.

    PMID: 28533696BACKGROUND
  • 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.

    PMID: 28625286BACKGROUND
  • 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.

    PMID: 17060018BACKGROUND
  • Ryan SA. The Treatment of Dysmenorrhea. Pediatr Clin North Am. 2017 Apr;64(2):331-342. doi: 10.1016/j.pcl.2016.11.004.

    PMID: 28292449BACKGROUND
  • 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.

    PMID: 11530120BACKGROUND
  • 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.

    PMID: 20705214BACKGROUND
  • French L. Dysmenorrhea in adolescents: diagnosis and treatment. Paediatr Drugs. 2008;10(1):1-7. doi: 10.2165/00148581-200810010-00001.

    PMID: 18162003BACKGROUND
  • 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.

    PMID: 25325520BACKGROUND
  • 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.

    PMID: 26309099BACKGROUND
  • ACOG Committee Opinion No. 760: Dysmenorrhea and Endometriosis in the Adolescent. Obstet Gynecol. 2018 Dec;132(6):e249-e258. doi: 10.1097/AOG.0000000000002978.

    PMID: 30461694BACKGROUND
  • Morrow C, Naumburg EH. Dysmenorrhea. Prim Care. 2009 Mar;36(1):19-32, vii. doi: 10.1016/j.pop.2008.10.004.

    PMID: 19231600BACKGROUND
  • 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.

    PMID: 26224322BACKGROUND
  • 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.

    PMID: 27000311BACKGROUND

Related Links

MeSH Terms

Conditions

PainMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Pelin Zöhre, Pt

    Yeditepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

July 27, 2023

Study Start

May 30, 2023

Primary Completion

July 20, 2023

Study Completion

August 30, 2023

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations