Clinical trial NCT06210659: The The Effect of Planned Behavior Theory-Based Education on Physical Activity and Dysmenorrhea
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea Primary
Keywords: Dysmenorrhea
Theory of Planned Behavior
Physical Activity
Pain
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups; intervention and control group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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,
* 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.

Exclusion Criteria:

* 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,
* 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 MONTHS
Secondary outcomes:
measure: Dysmenorrhea Impact Scale-Short Form
timeFrame: 4 MONTHS
measure: Physical Activity Scale
timeFrame: 4 MONTHS
measure: The Self-Effıcacy Scale
timeFrame: 4 MONTHS
measure: Daily Step Tracking
timeFrame: 4 MONTHS
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Ankara University
name: Basak Demirtas, PhD
role: PRINCIPAL_INVESTIGATOR
References: