NCT05646238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

December 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

November 30, 2022

Last Update Submit

May 8, 2023

Conditions

Keywords

copingnursing carestudentpsychoeducationdysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Menstrual pain severity using the Visual Analog Scale

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

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

Secondary Outcomes (2)

  • Functional and Emotional Dysmenorrhea Scale

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

  • 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)

Study Arms (2)

intervention group

EXPERIMENTAL

Students assigned to the experimental group will be divided into groups of 6-9. 3 psychoeducation sessions will be held with each group once a week for a total of 3 weeks. Group sessions are estimated to last between 60-75 minutes. Psychoeducational content based on Leventhal's Self-Regulation Model was prepared. In the first stage, cognitive bases of dysmenorrhea, in the second stage, strategies to cope with dysmenorrhea, and in the third stage, the effectiveness of coping strategies in dysmenorrhea will be discussed. In the second stage, the participants will be taught the progressive muscle relaxation exercise, which is among the strategies to cope with dysmenorrhea. Sessions will be held online.

Other: psychoeducation

control group

ACTIVE COMPARATOR

The control group will be given a online training of 30-45 minutes covering dysmenorrhea and coping in a single session. From the first menstrual cycle after the training session is completed, measurements will be made in 3 consecutive menstrual cycles.

Other: training

Interventions

Students assigned to the experimental group will be divided into groups of 6-9. 3 psychoeducation sessions will be held with each group once a week for a total of 3 weeks. Group sessions are estimated to last between 60-75 minutes. Psychoeducational content based on Leventhal's Self-Regulation Model was prepared. In the first stage, cognitive bases of dysmenorrhea, in the second stage, strategies to cope with dysmenorrhea, and in the third stage, the effectiveness of coping strategies in dysmenorrhea will be discussed. In the second stage, the participants will be taught the progressive muscle relaxation exercise, which is among the strategies to cope with dysmenorrhea. Sessions will be held online.

intervention group

The control group will be given a online training of 30-45 minutes covering dysmenorrhea and coping in a single session. From the first menstrual cycle after the training session is completed, measurements will be made in 3 consecutive menstrual cycles

control group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale students with dysmenorrhea
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Turkey

Ankara, 06300, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.

Related Links

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Those with a VAS score of 4 and above were assigned to the experimental and control groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant doctor

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 12, 2022

Study Start

December 7, 2022

Primary Completion

March 3, 2023

Study Completion

March 10, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations