NCT05290181

Brief Summary

The aim of this study is to evaluate the effect of Pilates exercise and Whatsapp text message-based support program on PMS symptoms experienced by university female students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 12, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 3, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

March 3, 2022

Last Update Submit

February 3, 2023

Conditions

Keywords

Premenstrual SyndromePilates exercisesText messagewomen's health

Outcome Measures

Primary Outcomes (1)

  • Premenstrual syndrome scale (PMSS)

    The premenstrual syndrome scale (PMSS) aims to measure the severity of symptoms. The scale consists of 44 items in 5-point Likert type. The Cronbach's alpha value of the scale was determined as 0.75. As stated in the PMSS directive, while filling out the scale, the participants should mark according to the symptoms they felt one week before the period. In scoring the scale, the "Never" option is 1 point, the "Very little" option is 2 points, the "Sometimes" option is 3 points, the "Frequently" option is 4 points, and the "Constantly" option is evaluated. as 5 points. While evaluating the PMSS results, the presence of PMS is evaluated according to the condition of passing 50% of the highest score that can be obtained from the total and subscale scores. The highest possible score for the total score is 220, 50% of which is 110. A score above 110 points on the scale indicates the presence of PMS.

    Baseline

Secondary Outcomes (1)

  • Premenstrual syndrome scale (PMSS)

    Immediately after the 8-week support intervention program

Study Arms (2)

Pilates exercise and whatsapp text message group

EXPERIMENTAL

A support program including pilates exercises and sending text messages will be applied to the students in the intervention group for 8 weeks. Online pilates exercises will be done 2 days a week and individual short messages will be sent to their smartphones via the Whatsapp application 3 days a week. Participants will be provided with Pre Pilates exercises, Pilates Mat Program: Beginner Level, Pilates Mat Program: Intermediate Level, Pilates Mat Program: Advanced level exercises. The exercises will be done online in the presence of a research physiotherapist with The Australian Physiotherapy \& Pilates InstituteMatwork Level 1 (APPI) certificate.

Other: A support program with pilates exercise and whatsapp text message

Control group

NO INTERVENTION

No intervention will be made in the control group.

Interventions

Female students in the intervention group will be given online pilates exercises 2 days a week for 8 weeks. Pre Pilates exercises, Pilates Mat Program: Beginner Level, Pilates Mat Program: Intermediate Level, Pilates Mat Program: Advanced level exercises will be provided. The exercises will be performed in the company of a research physiotherapist who has The Australian Physiotherapy \& Pilates InstituteMatwork Level 1 (APPI) certificate. 3 days a week, individual short messages will be sent to the smartphones of female students via the Whatsapp application. General information about PMS will be sent in the first week, and motivational messages about lifestyle will be sent in the following weeks. Short message contents will be prepared by researchers in line with the literature and expert opinion will be taken. When the support program ends, PMSS will be applied to female students in the intervention group.

Pilates exercise and whatsapp text message group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having regular menstrual cycles (intervals of 21-35 days, lasting 3-10 days),
  • Body mass index of 18.5-24.9 kg/m. to be between
  • Absence of chronic disease,
  • Absence of a hormonal disease such as polycystic ovary syndrome,
  • Using smart mobile phone
  • Not using oral contraceptives or antidepressants.

You may not qualify if:

  • \- Having a chronic or physical illness that prevents Pilates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin Adnan Menderes University

Aydin, Söke, 9000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Ayça Balmumcu, PhD

    Aydin Adnan Menderes University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 68 female students with PMS who met the inclusion criteria will be divided into groups using a simple random method. There will be 34 female students in the intervention group and 34 female students in the control group.In order to prevent interaction between the intervention and control group students in the randomization, the places where the students stay (home, dormitory rooms) will be taken into account. A support program including pilates exercises and sending text messages will be applied to the students in the intervention group for 8 weeks. Online pilates exercises will be done 2 days a week and individual short messages will be sent to their smartphones via the Whatsapp application 3 days a week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Women's health and obstetrics nursing

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 22, 2022

Study Start

January 12, 2022

Primary Completion

March 2, 2022

Study Completion

June 5, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations