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Enrolling by invitationNCT06403683Updated May 8, 2024

Physical Activity Level and Insomnia

An observational study in Primary Dysmenorrhea, sponsored by Cairo University. Enrolling by invitation at 1 site in Egypt. Open to female participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Cairo University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 25 Years
Sex
Female
01

Study summary

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

Read the detailed description

This study will be designed as a case-control study, 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: group A(75 patients complain from PD according to WaLIDD score)\& group B(75 patients don't complain from PD according to WaLIDD score). All data and information of each female in this study, including name, age, address, weight, height, and menstrual history, will be recorded in a recording data sheet. WaLIDD score will be used to assess PD symptoms, Insomnia Severity Index will be used to assess insomnia, International Physical Activity Questionnaire (Short-form)\& Six-Minute Walk Test will be used to assess physical activity levels. Inclusion criteria: 1)Patient ages will be ranged between 18-25 years old, 2)They do not receive any drugs, 3)Being a virgin. Participants will be excluded if they 1) Using hormonal contraception (such as oral contraceptives and injections), 2)Taking any medications, 3)History of chronic disease, 4)Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause). The subject, who missed for any of assessment session, would be withdraw form the research.

02

Conditions studied

  • Primary Dysmenorrhea

Keywords

  • Physical Activity Level
  • Insomnia
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's planned enrollment of 150 is above the median of 128 across 191 observational studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Sampling method
Probability 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:

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Using hormonal contraception (such as oral contraceptives and injections).
  2. Taking any medications.
  3. History of chronic disease.
  4. Having any psychiatric or gynecological problems (such as PCO, amenorrhea, women who suffered from menopause).
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

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

    Case control trial study

06

What researchers measure

Primary outcomes

  1. Insomnia

    Record insomnia severity during menstruation

    Time frame: Through study completion, an average of 6 months

  2. Physical activity level

    Record Physical activity level during menstruation

    Time frame: Through study completion, an average of 6 months

07

Study locations

1 site
  • Cairo University
    Giza, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06403683
Lead sponsor
Cairo University
Responsible party
Asmaa Adel Abdelaziz (Physiotherapy researcher, Cairo University) — Principal investigator
First posted
May 8, 2024
Start date
Jan 30, 2024
Primary completion
Apr 30, 2024 (estimated)
Completion
May 15, 2024 (estimated)
Last update
May 8, 2024

Study contacts

Dalia Mohamed Kamel, PhD
study chair · Department of Woman's Health, Faculty of Physical Therapy, Cairo University, Giza, Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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