NCT07771582

Brief Summary

This study aims to evaluate the effect of aerobic exercises and relaxation techniques on pain severity, quality of life, and menstrual symptoms in females with primary dysmenorrhea. Participants will be randomly assigned to either an exercise and relaxation group or a control group. The intervention group will perform aerobic exercises and relaxation sessions for 12 weeks, while the control group will receive no intervention. Pain levels, quality of life, and menstrual symptoms will be assessed before and after the intervention period.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

July 14, 2026

Last Update Submit

August 15, 2026

Conditions

Keywords

ExerciseWomenPrimary dysmenorrhoeaRelaxation

Outcome Measures

Primary Outcomes (2)

  • Serum cortisol level at week 12

    Serum cortisol levels will be measured from venous blood samples using a validated laboratory assay and reported in µg/dL (or nmol/L, depending on the laboratory). It will measured at baseline and after 12 weeks of the intervention.

    Baseline and 8week after the intervention

  • The Menstrual Distress Questionnaire

    The Menstrual Distress Questionnaire will be used to assess menstrual distress. It assesses 8 factors covered by 47 items. These factors include pain, concentration, behavioral change, autonomic reaction, water retention, negative effect, arousal and control.It is four point rating scale from non as no pain to severe. Maximum score is 141 meaning severe pain and minimum score is 1 meaning very mild pain

    12 weeks

Study Arms (2)

Merged exercise

EXPERIMENTAL

participants will receive a structured exercises program consists of hip exercises, ,Bridging exercises ,Cobra pose ,Adductor stretching

Behavioral: Exercise

Relaxation techniques

ACTIVE COMPARATOR

Participants will receive relaxation techniques including Meditation Yoga, Relaxation posture

Behavioral: Relaxation techniques

Interventions

ExerciseBEHAVIORAL

A structured exercises program consists of , Adductor stretching ,Bridging exercise, sit up exercises

Merged exercise

Astructured relaxation program consisting of Relaxation positure,yoga ,meditation

Relaxation techniques

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparticipants must be biologicallyfemale and self identify as female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • a history of pelvic inflammatory disease.
  • myoma and tumors.
  • pelvic infection,.
  • ovarian cyst.
  • any gynecological disease.
  • any hormonal abnormality.
  • any psychological problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo university

Giza, Giza Government, 12654, Egypt

Location

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseRelaxation Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HAH student

Study Record Dates

First Submitted

July 14, 2026

First Posted

August 18, 2026

Study Start

February 12, 2025

Primary Completion

May 12, 2025

Study Completion

May 1, 2026

Last Updated

August 18, 2026

Record last verified: 2026-08

Locations