Examination of Menstruation Symptoms in Women Who Exercise Regularly.

Sponsor
Uskudar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06006507
Collaborator
(none)
50
1
2
3.9
12.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: control
  • Other: exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Exercise treatmentsExercise treatments
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Examination of Menstruation Symptoms in Women Who Exercise Regularly.
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

no exercise will be given

Other: control
no exercise will be given

Experimental: exercise group

exercise training will be given and they will be asked to exercise regularly.

Other: exercise
In line with the recommendation of the World Health Organization, the exercise group will do 150 minutes of moderate-intensity walking a week and strengthening exercises prepared by the physiotherapist two days a week. Strengthening exercises will be taught by the physiotherapist in a session with the people in the exercise group in groups of five, and then exercise lists will be given to the people on digital exercise platform, where there are video narrations of the exercises. In addition, the participants will be asked to do balance exercises and macular exercise.

Outcome Measures

Primary Outcome Measures

  1. Pittsburgh Sleep Quality Scale [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.

  2. Fatigue Severity Scale [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".

  3. Short form of the International Physical Activity Questionnaire [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.

  4. Menstruation Symptom Scale [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.

  5. Menstruation Distress Complaints List [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Üsküdar Unıversıty Beşiktaş İstanbul Turkey

Sponsors and Collaborators

  • Uskudar University

Investigators

  • Study Chair: Merve KOÇAK, Bahçeşehir University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
ClinicalTrials.gov Identifier:
NCT06006507
Other Study ID Numbers:
  • Uskudar58
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023