Physical Activity Level and Insomnia

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

• Registration Number: NCT06403683
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-01-30
• Study First Submitted: 2024-04-26
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Females with primary dysmenorrhoea	WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test	75 females complain from primary dysmenorrhoea according to WaLIDD score.
Females without primary dysmenorrhoea	WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test	75 females don't complain from primary dysmenorrhoea according to WaLIDD score.

Primary Outcome Measures

Name	Time	Method
Physical activity level	Through study completion, an average of 6 months	Record Physical activity level during menstruation
Insomnia	Through study completion, an average of 6 months	Record insomnia severity during menstruation

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt