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Clinical Trials/NCT05646238
NCT05646238CompletedNot Applicable

The Effect of Psychoeducation Based on Leventhal's Self-Regulation Model on Dysmenorrhea in Nursing Students: A Single-Blind Randomized Controlled Study

Gazi University3 sites in 1 country61 target enrollmentStarted: December 7, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61
Locations
3
Primary Endpoint
Menstrual pain severity using the Visual Analog Scale

Study Overview

Brief Summary

This study will be conducted to examine the effect of psychoeducation based on Leventhal's Self-Regulation Model on dysmenorrhea in nursing students.

Detailed Description

This study will be conducted to examine the effect of psychoeducation based on Leventhal's Self-Regulation Model on dysmenorrhea in nursing students.

Hypotheses of the Research

H0a: There is no difference in menstrual pain severity between the experimental group and the control group receiving psychoeducation based on Leventhal's Self-Regulation Model.

H0b: There is no difference between the Functional and Emotional Dysmenorrhea Scale mean scores between the experimental group and the control group receiving psychoeducation based on Leventhal's Self-Regulation Model.

H0c: There is no difference between the Menstruation Symptom Scale mean scores between the experimental group receiving psychoeducation based on Leventhal's Self-Regulation Model and the control group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

Those with a VAS score of 4 and above were assigned to the experimental and control groups.

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Having a regular menstrual cycle of 6 months
  • Being Nulliparous
  • Getting 4 or more points from VAS
  • Having smart phone and internet facility
  • Having the technical means to use the ZOOM application
  • Volunteering to participate in the research

Exclusion Criteria

  • Having a diagnosis of any gynecological disease
  • Having a history of gynecological surgery
  • Having an active vaginal infection
  • Not having received psychosocial counseling for dysmenorrhea before

Outcomes

Primary Outcomes

Menstrual pain severity using the Visual Analog Scale

Time Frame: Change from before implementation, 3th week of the practice, at the beginning of menstruation (for 3 months)

Ranges for pain intensity; \<3 mild pain, 3-6 moderate pain, \>6 severe pain

Secondary Outcomes

  • Menstrual pain severity using the Menstruation Symptom Scale(Change from before implementation and 3th week of the practice, at the beginning of menstruation (for 3 months))
  • Functional and Emotional Dysmenorrhea Scale(Change from before implementation, 3th week of the practice, at the beginning of menstruation (for 3 months))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merve Işık

research assistant doctor

Gazi University

Study Sites (3)

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