The The Effect of Planned Behavior Theory-Based Education on Physical Activity and Dysmenorrhea

NCT06210659 | Unknown

• 1 other identifier: AnkaraU-HEM-RK-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea Primary

Keywords

Dysmenorrhea; Theory of Planned Behavior; Physical Activity; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  4 MONTHS

Secondary Outcomes (4)

• Dysmenorrhea Impact Scale-Short Form

  4 MONTHS

• Physical Activity Scale

  4 MONTHS

• The Self-Effıcacy Scale

  4 MONTHS

• Daily Step Tracking

  4 MONTHS

Study Arms (2)

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.

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.

Interventions

Theory of Planned Behavior Based Training Program BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Due to women experiencing primary dysmenorrhea.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Bitlis Eren University

Bitlis, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Basak Demirtas, PhD

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aycin Cifci

CONTACT

+905375648713; aycincifci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD STUDENT

Model Details: 2 groups; intervention and control group

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)