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Clinical Trials/NCT06522126
NCT06522126CompletedNot Applicable

The Effects of Progressive Relaxation Exercise on Life Satisfaction, Anxiety, and Psychological Well-being in Students Experiencing Premenstrual Syndrome: A Randomized Controlled Trial

Inonu University1 site in 1 country162 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
162
Locations
1
Primary Endpoint
Premenstrual Syndrome Scale (PMSS)

Study Overview

Brief Summary

Aim: This research was conducted to determine the effects of progressive relaxation exercise on life satisfaction, anxiety, and psychological well-being in people experiencing premenstrual syndrome.

Methods: This randomized controlled trial was conducted with students who were enrolled in a university in the east of Türkiye, studying at the undergraduate levels outside the field of health, and experiencing premenstrual syndrome. The sample of the research consisted of 162 students (Exercise group 81 participants; Control group 81 participants). The Personal Information Form, Premenstrual Syndrome Scale (PMSS), Life Satisfaction Scale (LSS), Beck Anxiety Scale (BAS), and Psychological Well-Being Scale (PWBS) were used to collect data. Women in the exercise group underwent eight sessions of relaxation exercises, once a week for 8 weeks. In addition, for eight weeks after the first exercise, the participants exercised at home, at least twice a week, outside of the training. The PMSS, LSS, BAS, and PWBS were applied as post-tests to the participants in both groups, 8 weeks after the pre-tests.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Those who scored 111 points or more on the Premenstrual Syndrome Scale,
  • •were married or single at the time of the research,
  • •did not have children.

Exclusion Criteria

  • •those who were pregnant or postpartum,
  • •those who were diagnosed with any psychiatric disease according to the records,
  • •those who did not perform relaxation exercises outside of the training.

Arms & Interventions

effects of progressive relaxation exercise

Experimental

Progressive relaxation exercises were given to female students who scored 111 and above on the PMS scale and were selected by randomization for the exercise group. The exercises were applied to those who participated in the study, met the inclusion criteria, and were able to participate in the study for 8 weeks. In the study, progressive relaxation exercises were applied by the researcher to the students in the exercise group with PMS complaints in the first three days of their first menstrual cycle.

Intervention: progressive relaxation exercise (Behavioral)

control groups

No Intervention

Control group standard care group

Outcomes

Primary Outcomes

Premenstrual Syndrome Scale (PMSS)

Time Frame: 8 weeks

It is a 44-item Likert-type scale developed by Gençdoğan (2006) that measures the severity of premenstrual symptoms. The scale has nine subscales, and the "PMSS total score" consisting of the scores related to the subscales and the total of the scale is obtained. The application of PMSS is done by retrospectively evaluating the person's status "one week before menstruation". The lowest score that can be obtained from the scale is 44 and the highest score is 220. The higher the score, the more intense the premenstrual syndrome symptoms are considered. The highest score that can be obtained for the total score is 220, 50% of which is 110 points. Therefore, those who score 111 and higher have PMS in terms of total score.

Secondary Outcomes

  • Life Satisfaction Scale (LSS)(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Esra SABANCI BARANSEL

Assistant professor

Inonu University

Study Sites (1)

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