NCT06321224

Brief Summary

The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

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

March 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 13, 2024

Last Update Submit

March 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Menstrual pain intensity

    Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain".

    After 2 menstrual periods

Secondary Outcomes (4)

  • Menstrual symptoms

    After 2 menstrual periods

  • Life quality

    After 2 menstrual periods

  • Stress level

    After 2 menstrual periods

  • Sleep quality

    After 2 menstrual periods

Study Arms (2)

Exercise group

EXPERIMENTAL

The exercise group will be given breathing exercises

Other: Breathing exercises

Control group

OTHER

The control group will be asked to continue their routine lives.

Other: Control

Interventions

Breathing exercises will be performed 3 days a week during 2 menstrual periods.

Exercise group
ControlOTHER

No intervention will be made to the control group and they will be asked to continue their routine lives.

Also known as: Routine live
Control group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimary dysmenorrhea is a gynecological problem that can be seen in most women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having PD symptoms according to the Primary Dysmenorrhea Consensus criteria,
  • Having menstrual pain intensity of 4 or higher according to the Visual Analog Scale in the last 6 months,
  • Having a regular menstrual cycle (28±7 days)
  • Volunteering to participate in the study.

You may not qualify if:

  • Being pregnant or suspected of pregnancy,
  • Using oral contraceptives or antidepressants in the last 6 months,
  • Using intrauterine devices,
  • Having a history of other gynecological diseases
  • Having pulmonary, neurological and/or systemic disease,
  • Having undergone abdominal or cardiothoracic surgery within the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

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
associate professor

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

March 1, 2025

Last Updated

March 20, 2024

Record last verified: 2024-03