Effect of Pelvic Floor-Based Training on Dysmenorrhea

September 12, 2024 updated by: tuba kolaylı, Uskudar University

The Effect of Pelvic Floor-Based Training on Young Women With Dysmenorrhea

The aim of this study is to examine the effect of patient education, knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. The main question it aims to answer is the questions are as follows:

  1. Is patient education effective in improving symptoms in young women with primary dysmenorrhea?
  2. Is there a relationship between knowledge level and symptoms in young women with primary dysmenorrhea?

Participants will:

After the training group was given the training in 2 sessions, the participants were asked to apply the exercises in which the training was given. The control group applied conventional self-methods when dysmenorrhea symptoms occurred. The evaluations were made before the training and at the end of the first menstrual cycle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Dysmenorrhea is pain that occurs during menstruation due to cramps in the uterus. It is one of the most common causes of pelvic pain, especially experienced by young women. primary dysmenorrhea is distinguished from secondary dysmenorrhea by the occurrence of pain in women with normal pelvic anatomy without any pathology or physiological etiology. In the management of primary dysmenorrhea, non-pharmacological treatment methods such as lifestyle changes, sleep and nutrition changes, exercise, and physiotherapy applications are used in addition to pharmacological treatments. The aim of this study is to examine the effect of patient education on the pelvic floor knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. In this study, participants were divided into two groups: the education group and the control group. The evaluations were made before the education and after the first menstrual cycle. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. The change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". The "Chi-Square Test" will be used to examine the relationship between categorical variables. The relationship between numerical variables will be examined with the "Spearman rho correlation coefficient". The probability of error will be accepted as (p<0.05).

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with primary dysmenorrhea
  • Being between the ages of 18-35
  • Having a regular menstrual cycle
  • Volunteering to participate in the study

Exclusion Criteria:

  • Not having a history of endometriosis or gynecological pathology •
  • Having a history of gynecological disease or surgery
  • Having a neurological or musculoskeletal problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
Pelvic floor and exercise training was given by physiotherapists.
Other: Education and exercise
Training including information on pelvic floor and dysmenorrhea and exercise practices were given both theoretically and practically by physiotherapists.
Active Comparator: Control group
Classical self-methods such as hot application were applied
Other: Self-method like resting or heat
Classical self-methods such as rest and heat application were applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 1 month
VAS , is used to determine the subjective perceived pain intensity. People with pain are expected to mark the pain intensity they feel on a 0-10 cm scale. The value of '0' indicates no pain, while the value of '10' indicates the most severe pain. VAS is used to assess menstrual pain intensity in individuals with primary dysmenorrhea.
1 month
Pelvic Floor Health Knowledge Test
Time Frame: 1 month
PFHKT, was developed in Turkish by Wala'a and Çelenay to measure the knowledge level of people about the pelvic floor. Each correct answer to the questions in the test is given '1' point, each wrong or blank answer is given '0' point. The lowest score that can be obtained from the scale is '0' and the highest score is '29'. An increase in the score obtained in the test, which has been studied for validity and reliability, indicates a higher level of knowledge.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysmenorrhea Affect Scale
Time Frame: 1 month
DAS, was developed to provide a holistic assessment of dysmenorrhea. The scale includes health perception/management, nutrition and metabolism, excretion, activity and exercise, sleep and rest, cognition and perception, self-perception, role and relationship, sexuality and productivity in Gordon's functional health patterns model. There are items based on the topics of coping with stress and stress tolerance, values and beliefs. As the participants' scores on the scale increase, their level of being affected by dysmenorrhea also increases.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61351342/2023-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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