NCT06403683

Brief Summary

This study aims to investigate the relationship between physical activity levels and insomnia in females with primary dysmenorrhea.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

January 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

April 26, 2024

Last Update Submit

May 4, 2024

Conditions

Keywords

Physical Activity LevelInsomnia

Outcome Measures

Primary Outcomes (2)

  • Insomnia

    Record insomnia severity during menstruation

    Through study completion, an average of 6 months

  • Physical activity level

    Record Physical activity level during menstruation

    Through study completion, an average of 6 months

Study Arms (2)

Females with primary dysmenorrhoea

75 females complain from primary dysmenorrhoea according to WaLIDD score.

Diagnostic Test: WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test

Females without primary dysmenorrhoea

75 females don't complain from primary dysmenorrhoea according to WaLIDD score.

Diagnostic Test: WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test

Interventions

Case control trial study

Females with primary dysmenorrhoeaFemales without primary dysmenorrhoea

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study will be conducted on 150 females recruited from El\_ Nassr hospital in Helwan, Cairo, Egypt and from social media. Patients will be divided into two equal groups:

You may qualify if:

  • Patient ages will be ranged between 18-25 years old.
  • They do not receive any drugs.
  • Being a virgin .

You may not qualify if:

  • Using hormonal contraception (such as oral contraceptives and injections).
  • Taking any medications.
  • History of chronic disease.
  • Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Dalia Mohamed Kamel, PhD

    Department of Woman's Health, Faculty of Physical Therapy, Cairo University, Giza, Egypt

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy researcher

Study Record Dates

First Submitted

April 26, 2024

First Posted

May 8, 2024

Study Start

January 30, 2024

Primary Completion

April 30, 2024

Study Completion

May 15, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations