Primary DysmenorrheaNCT06403683
Physical Activity Level and Insomnia
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the relationship between physical activity levels and insomnia in females with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2024to 15 May 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Adult
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:
Who may be able to join
- Patient ages will be ranged between 18-25 years old.
- They do not receive any drugs.
- Being a virgin .
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test
- Keywords
- Physical Activity Level, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk TestDiagnostic test
Case control trial study
| Study group | Role | What they receive |
|---|---|---|
| Females with primary dysmenorrhoea | 75 females complain from primary dysmenorrhoea according to WaLIDD score. Receives: 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. Receives: Diagnostic Test: WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia
Record insomnia severity during menstruation
Measured: Through study completion, an average of 6 months
Physical activity level
Record Physical activity level during menstruation
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Jan 2024
- Primary completion30 Apr 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Adel Abdelaziz, Cairo University
- Investigators
- Dalia Mohamed Kamel, PhD, Study chair, Department of Woman's Health, Faculty of Physical Therapy, Cairo University, Giza, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403683
- Sponsor's protocol ID
- P.T.REC/012/004951
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Physical Activity Levels and Insomnia in Females With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06403683
- Acronym / sponsor ID
- P.T.REC/012/004951
- Conditions
- Primary Dysmenorrhea
- Keywords
- Physical Activity Level, Insomnia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females with primary dysmenorrhoea | – | Diagnostic Test: WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test75 females complain from primary dysmenorrhoea according to WaLIDD score. |
| Females without primary dysmenorrhoea | – | Diagnostic Test: WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk Test75 females don't complain from primary dysmenorrhoea according to WaLIDD score. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Age groups
- Adult
- 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:
Key inclusion criteria (3 listed)
- Patient ages will be ranged between 18-25 years old.
- They do not receive any drugs.
- Being a virgin .
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaLIDD score / Insomnia Severity Index (ISI) / International Physical Activity Questionnaire (Short-form) / Six-Minute Walk TestCase control trial study | Diagnostic test | Females with primary dysmenorrhoea, Females without primary dysmenorrhoea |
Primary outcome
Insomnia
Time frame: Through study completion, an average of 6 months
Record insomnia severity during menstruation
Physical activity level
Time frame: Through study completion, an average of 6 months
Record Physical activity level during menstruation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Mohamed Kamel, PhD study chair
Department of Woman's Health, Faculty of Physical Therapy, Cairo University, Giza, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.