Physical Activity Level and Insomnia

May 4, 2024 updated by: Asmaa Adel Abdelaziz, Cairo University

Relationship Between Physical Activity Levels and Insomnia in Females With Primary Dysmenorrhea

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

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:

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Case control trial study
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
Case control trial study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia
Time Frame: Through study completion, an average of 6 months
Record insomnia severity during menstruation
Through study completion, an average of 6 months
Physical activity level
Time Frame: Through study completion, an average of 6 months
Record Physical activity level during menstruation
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Dalia Mohamed Kamel, PhD, Department of Woman's Health, Faculty of Physical Therapy, Cairo University, Giza, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004951

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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