Effect of Pelvic Floor-Based Training on Dysmenorrhea

NCT06600230 | Recruiting

• 1 other identifier: 61351342/2023-41
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysmenorrhea

Keywords

dysmenorrhea; pelvic floor; physiotherapy; exercise education

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  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

  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 Outcomes (1)

• Dysmenorrhea Affect Scale

  1 month

Study Arms (2)

Interventional group

EXPERIMENTAL

Pelvic floor and exercise training was given by physiotherapists.

Other: Education and exercise

Control group

ACTIVE COMPARATOR

Classical self-methods such as hot application were applied

Other: Self-method like resting or heat

Interventions

Education and exercise OTHER

Training including information on pelvic floor and dysmenorrhea and exercise practices were given both theoretically and practically by physiotherapists.

Interventional group

Self-method like resting or heat OTHER

Classical self-methods such as rest and heat application were applied.

Control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Educational Status; Exercise; Hot Temperature

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Central Study Contacts

Tuba Kolaylı, PhD(c)

CONTACT

(216)4002222; tubakolayli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Before - after trial

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: August 20, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)