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Clinical Trials/NCT06006507
NCT06006507
Completed
Not Applicable

The Effect of Exercise on Menstrual Symptoms: a Randomised Controlled Trial

Uskudar University1 site in 1 country54 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Menstrual Problem
Sponsor
Uskudar University
Enrollment
54
Locations
1
Primary Endpoint
Pittsburgh Sleep Quality Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to contribute to the determination of the relationship between exercise and menstrual symptoms and to create an alternative for non-pharmacological coping methods with menstrual symptoms.

Detailed Description

The type of research is randomized controlled trial. An average of 50 people who do not have exercise habits will participate in the study, and two randomized groups will be formed as exercise group and control group. Everyone will be asked to fill in the Menstruation Symptom Scale, the Menstruation Distress Scale, the Pittsburgh Sleep Quality Scale, the Fatigue Severity Scale, the International Physical Activity Scale, the Personal Information Form prepared by us, and the Voluntary and Consent Form during their menstrual period. The duration of the study will cover 3 (three) menstrual periods of the individuals. At the beginning and end of the study; They will be asked to fill in the Pittsburgh Sleep Quality Scale, Fatigue severity scale, International Physical Activity Questionnaire Short form, Menstruation Symptom Scale and Menstruation Distress Complaint List.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
December 20, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Uskudar University
Responsible Party
Principal Investigator
Principal Investigator

Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Uskudar University

Eligibility Criteria

Inclusion Criteria

  • Women between the ages of 18-50 whose menstrual cycle continues,
  • Those who have emotional or physical problems during menstruation periods,
  • Those whose menstrual cycle is between 21-40 days on average

Exclusion Criteria

  • Those with chronic disease
  • Those with a diagnosed gynecological disease,
  • Those who receive any medical treatment,
  • Persons with dysmenorrhea and anemia.
  • People who exercise regularly.

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Scale

Time Frame: 14 weeks

The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep. It includes 24 questions in total. The self-assessment questions include various items related to sleep quality. The total score is between 0-21. A high total score indicates poor sleep quality. The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances. However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality.

Menstruation Distress Complaints List

Time Frame: 14 weeks

He questions the severity of these symptoms one week before the menstruation, during the last menstruation, and on other days. Complaints are scored from 0 to 4. These are 0: no symptoms, 1: little, 2: moderate, 3: severe, and 4: very severe. The lowest score that can be obtained from the scale is 0 for each term, and the highest score is 188.

Fatigue Severity Scale

Time Frame: 14 weeks

It consists of 9 questions. Each question is scored between 1 and 7. Statements Regarding Scoring 1. I strongly disagree 3. I tend to disagree 5. I tend to agree 2. I disagree 4. I am undecided 6. I agree 7. I strongly agree. ) the score of the answers given to the question is added and divided by 9. If the result is less than 2.8, it is evaluated as "no fatigue". If the result is greater than 6.1, it is considered as "chronic fatigue syndrome".

Short form of the International Physical Activity Questionnaire

Time Frame: 14 weeks

provides information on time spent walking, moderate and vigorous activities, and time spent sitting. Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity. The energy required for activities is calculated with the metabolic equivalent(MET) -minute score. Standard metabolic equivalent (MET) values have been established for these activities.

Menstruation Symptom Scale

Time Frame: 14 weeks

It is a 5-point Likert-type scale and consists of three sub-parameters: 'negative effects/somatic effects', 'menstrual pain' and 'coping methods', and 22 items. The person is asked to give a score between '1' never and '5' always for the symptoms they experience related to menstruation. The Menstruation Symptom Scale (MSS) score is calculated by taking the total score average. An increase in the mean score indicates an increase in the severity of menstrual symptoms.

Study Sites (1)

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