Dysmenorrhea PrimaryNCT06210659
The The Effect of Planned Behavior Theory-Based Education on Physical Activity and Dysmenorrhea
A study testing Theory of Planned Behavior Based Training Program in people with Dysmenorrhea Primary, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effect of the planned behavior theory-based education program applied to university students with primary dysmenorrhea on physical activity behavior and dysmenorrhea's impact. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Theory of Planned Behavior Based Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2024to Jan 2024
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Last menstrual pain is 5 points or more out of 10 on the Visual Pain Scale (moderate/severe/unbearable pain),
- Being 18 years or older,
- Reading and writing Turkish,
- Receiving education at undergraduate level,
- Being a first year student,
- Being nulliparous (never giving birth) and never having had a pregnancy,
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- Having a regular menstrual cycle (every 21-35 days, lasting 3-8 days and without complaints of intermittent bleeding) for the last 6 months,
- Being inactive or minimally active according to the International Physical Activity Survey,
- Being diagnosed with primary dysmenorrhea by the physician,
- Agreeing to participate in the study.
Who cannot join
- Receiving education at the health vocational high school level,
- Last menstrual pain is 4 points or less out of 10 on the Visual Pain Scale,
- Having any gynecological diagnosis (endometriosis, ovarian cyst, myoma, polyp, etc.),
- Having undergone a gynecological operation (hysterectomy, myomectomy, etc.),
- Being on hormonal drug therapy,
- Having an orthopedic disability (congenital limb deficiencies, congenital hip dislocation, scoliosis, meningomyolocele, cerebral palsy, etc.), visual disability (vision loss, peripheral retinopathy, hemianopia, night blindness, etc.) and hearing disability that would prevent physical activity,
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- Having acute or severe pain that increases with movement,
- Having a known systemic and chronic disease (diabetes, heart disease, vascular diseases, circulatory disorders, varicose veins, blood diseases, etc.),
- Having any psychiatric diagnosis (depression, anxiety disorder, etc.)
- Not agreeing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bitlis Eren University
Bitlis
Aycin Cifci, +905375648713, aycincifci@gmail.com
About this study
Official title: The The Effect of Planned Behavior Theory-Based Education Program Applied to University Students With Primary Dysmenorrhea on Physical Activity Behavior and the Level of Affected by Dysmenorrhea
The aim of the study is to examine the effect of the planned behavior theory-based education program applied to university students with primary dysmenorrhea on physical activity behavior and dysmenorrhea's impact.
Read the detailed description
The study was planned to be conducted as a randomized controlled experimental study in the pre-test-post-test order.
The research was planned to be conducted at Bitlis Eren University. The population of the research consists of first year students studying at the Faculty of Arts and Sciences, Faculty of Fine Arts, Faculty of Economics and Administrative Sciences, Faculty of Islamic Sciences, Faculty of Engineering and Architecture, who are studying at Bitlis Eren University in the 2023-2024 academic year.
The sample of the research will consist of 54 students who meet the inclusion criteria and agree to participate in the research. Considering the possible losses that may occur during the research process, a total of 68 students are planned to be accepted.
The research data were collected with; "Inclusion Criteria Questionnaire", "Exhibitor Introduction Form", "Visual Pain Scale", "Physical Activity Scale", "Dysmenorrhea Impact Scale Short Form", "The Self-Effıcacy Scale" and "Daily Step Tracking Form".
In the research, Planned Behavior Theory Based Training Program consisting of 4 sessions will be applied to the intervention group, and information will be given to the control group about the process of the research and the data collection forms to be used. Students in both groups will have 3 menstrual cycles after the education.
In the study, it is planned to use descriptive statistics (number, percentage, mean and standard deviation) in the analysis of quantitative data, t test and Mann Whitney U test in the comparison of paired groups, Mcnemar test in the comparison of two groups, analysis of variance in the comparison of multiple groups, and Pearson and Spearman correlation analysis in relational inferences.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Theory of Planned Behavior Based Training Program
- Keywords
- Dysmenorrhea, Theory of Planned Behavior, Physical Activity, Pain
- Medical subject headings
- Dysmenorrhea, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory of Planned Behavior Based Training ProgramBehavioural
Theory of Planned Behavior Based Training Program will be implemented. The training program will consist of 4 sessions. First session; It will consist of the definition, symptoms and treatment approaches of primary dysmenorrhea. Content of the second session; It will consist of lifestyle interventions in dysmenorrhea. Content of the third session; It will consist of the importance of physical activity in primary dysmenorrhea. The fourth session consists of a group walk.
Students will be monitored for 3 menstrual cycles. Starting from the end of the first menstrual period after completion of the training session, students will be asked to record their daily step count using a pedometer. In each menstrual period, the average of the students' monthly step count and average menstrual pain score will be evaluated. After the training sessions are completed, students will be given an end-of-menstrual motivational interview for 3 menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Theory of Planned Behavior Based Training Program will be implemented. The training program will consist of 4 sessions. Students will be monitored for 3 menstrual cycles. Starting from the end of the first menstrual period after completion of the training session, students will be asked to record their daily step count using a pedometer. In each menstrual period, the average of the students' monthly step count and average menstrual pain score will be evaluated. After the training sessions are completed, students will be given an end-of-menstrual motivational interview for 3 menstrual cycles. Receives: Behavioral: Theory of Planned Behavior Based Training Program |
| Control group | No intervention | Students will be required to record their daily step count using a pedometer. Students will be monitored for 3 menstrual cycles. In each menstrual period, the average of the students' monthly step count and average menstrual pain score will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
"0" IS DEFINED AS NO PAIN, "10" IS DEFINED AS VERY SEVERE PAIN. AS THE VALUE INCREASES, THE SEVERITY OF PAIN INCREASES.
Measured: 4 MONTHS
Secondary outcomes (4)
Dysmenorrhea Impact Scale-Short Form
It consists of 13 items. The scale is five-point Likert type. As the score obtained from the scale increases, the level of individuals being affected by dysmenorrhea also increases.
Measured: 4 MONTHS
Physical Activity Scale
It was developed based on the "Theory of Planned Behavior". It consists of 30 items. As the total score average obtained from the physical activity scale increases, knowledge, behavior and status towards physical activity increase positively.
Measured: 4 MONTHS
The Self-Effıcacy Scale
It consists of 23 items. Five-point Likert type scale. A high total score indicates that the general self-efficacy-sufficiency perception is high.
Measured: 4 MONTHS
Daily Step Tracking
The daily step count will be recorded with the pedometer. The monthly average number of steps will be recorded.
Measured: 4 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups; intervention and control group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aycin Cifci, Ankara University
- Investigators
- Basak Demirtas, PhD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210659
- Sponsor's protocol ID
- AnkaraU-HEM-RK-01
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The The Effect of Planned Behavior Theory-Based Education Program Applied to University Students With Primary Dysmenorrhea on Physical Activity Behavior and the Level of Affected by Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06210659
- Acronym / sponsor ID
- AnkaraU-HEM-RK-01
- Conditions
- Dysmenorrhea Primary
- Keywords
- Dysmenorrhea, Theory of Planned Behavior, Physical Activity, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Jan 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.
The aim of the study is to examine the effect of the planned behavior theory-based education program applied to university students with primary dysmenorrhea on physical activity behavior and dysmenorrhea's impact.
Detailed description
The study was planned to be conducted as a randomized controlled experimental study in the pre-test-post-test order.
The research was planned to be conducted at Bitlis Eren University. The population of the research consists of first year students studying at the Faculty of Arts and Sciences, Faculty of Fine Arts, Faculty of Economics and Administrative Sciences, Faculty of Islamic Sciences, Faculty of Engineering and Architecture, who are studying at Bitlis Eren University in the 2023-2024 academic year.
The sample of the research will consist of 54 students who meet the inclusion criteria and agree to participate in the research. Considering the possible losses that may occur during the research process, a total of 68 students are planned to be accepted.
The research data were collected with; "Inclusion Criteria Questionnaire", "Exhibitor Introduction Form", "Visual Pain Scale", "Physical Activity Scale", "Dysmenorrhea Impact Scale Short Form", "The Self-Effıcacy Scale" and "Daily Step Tracking Form".
In the research, Planned Behavior Theory Based Training Program consisting of 4 sessions will be applied to the intervention group, and information will be given to the control group about the process of the research and the data collection forms to be used. Students in both groups will have 3 menstrual cycles after the education.
In the study, it is planned to use descriptive statistics (number, percentage, mean and standard deviation) in the analysis of quantitative data, t test and Mann Whitney U test in the comparison of paired groups, Mcnemar test in the comparison of two groups, analysis of variance in the comparison of multiple groups, and Pearson and Spearman correlation analysis in relational inferences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups; intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Theory of Planned Behavior Based Training ProgramTheory of Planned Behavior Based Training Program will be implemented. The training program will consist of 4 sessions. Students will be monitored for 3 menstrual cycles. Starting from the end of the first menstrual period after completion of the training session, students will be asked to record their daily step count using a pedometer. In each menstrual period, the average of the students' monthly step count and average menstrual pain score will be evaluated. After the training sessions are completed, students will be given an end-of-menstrual motivational interview for 3 menstrual cycles. |
| Control group | No intervention | –Students will be required to record their daily step count using a pedometer. Students will be monitored for 3 menstrual cycles. In each menstrual period, the average of the students' monthly step count and average menstrual pain score will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Last menstrual pain is 5 points or more out of 10 on the Visual Pain Scale (moderate/severe/unbearable pain),
- Being 18 years or older,
- Reading and writing Turkish,
- Receiving education at undergraduate level,
- Being a first year student,
Key exclusion criteria (10 listed)
- Receiving education at the health vocational high school level,
- Last menstrual pain is 4 points or less out of 10 on the Visual Pain Scale,
- Having any gynecological diagnosis (endometriosis, ovarian cyst, myoma, polyp, etc.),
- Having undergone a gynecological operation (hysterectomy, myomectomy, etc.),
- Being on hormonal drug therapy,
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 |
|---|---|---|
| Theory of Planned Behavior Based Training ProgramTheory of Planned Behavior Based Training Program will be implemented. The training program will consist of 4 sessions. First session; It will consist of the definition, symptoms and treatment approaches of primary dysmenorrhea. Content of the second session; It will consist of lifestyle interventions in dysmenorrhea. Content of the third session; It will consist of the importance of physical activity in primary dysmenorrhea. The fourth session consists of a group walk. Students will be monitored for 3 menstrual cycles. Starting from the end of the first menstrual period after completion of the training session, students will be asked to record their daily step count using a pedometer. In each menstrual period, the average of the students' monthly step count and average menstrual pain score will be evaluated. After the training sessions are completed, students will be given an end-of-menstrual motivational interview for 3 menstrual cycles. | Behavioural | Intervention group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 4 MONTHS
"0" IS DEFINED AS NO PAIN, "10" IS DEFINED AS VERY SEVERE PAIN. AS THE VALUE INCREASES, THE SEVERITY OF PAIN INCREASES.
4 secondary outcomes
Dysmenorrhea Impact Scale-Short Form
Time frame: 4 MONTHS
Physical Activity Scale
Time frame: 4 MONTHS
The Self-Effıcacy Scale
Time frame: 4 MONTHS
Daily Step Tracking
Time frame: 4 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Basak Demirtas, PhD principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory of Planned Behavior Based Training Program in people with Dysmenorrhea Primary, run by Ankara University at 1 site in Turkey (Türkiye).
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 10 inclusion and 10 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 18 Jan 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 Turkey (Türkiye). 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?
Contact Aycin Cifci (+905375648713, aycincifci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 4 MONTHS). 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 18 Jan 2024.