Physical Activity Level and Insomnia

NCT ID: NCT06403683

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-30

Study Completion Date

2024-05-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Primary Dysmenorrhea

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Females with primary dysmenorrhoea

75 females complain from primary dysmenorrhoea according to WaLIDD score.

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

Intervention Type DIAGNOSTIC_TEST

Case control trial study

Females without primary dysmenorrhoea

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

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

Intervention Type DIAGNOSTIC_TEST

Case control trial study

Interventions

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

Case control trial study

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Adel Abdelaziz

Physiotherapy researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia Mohamed Kamel, PhD

Role: STUDY_CHAIR

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

Locations

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Cairo University

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/004951

Identifier Type: -

Identifier Source: org_study_id

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