NCT06522126

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

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

September 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

July 22, 2024

Last Update Submit

August 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Syndrome Scale (PMSS)

    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.

    8 weeks

Secondary Outcomes (1)

  • Life Satisfaction Scale (LSS)

    8 weeks

Other Outcomes (1)

  • Beck Anxiety Scale (BAS)

    8 weeks

Study Arms (2)

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.

Behavioral: progressive relaxation exercise

control groups

NO INTERVENTION

Control group standard care group

Interventions

One of the techniques employed to mitigate the prevalence of PMS complaints in women during this period is progressive relaxation exercises (PRE). It is one of the most preferred options due to its simplicity, cost-effectiveness, and reliability. Over the course of numerous years of research, progressive relaxation has been validated as an efficacious approach for regulating muscle tension. These exercises are performed to facilitate the distinction between tension and looseness in the body and to enable the individual to relax on her own in daily life. PRE involves the voluntary, systematic tension and relaxation of large muscle groups in the human body. PRE reduces anxiety levels by reducing muscle tension. It also provides the individual with a sense of profound rest, renewal, and rebirth.

effects of progressive relaxation exercise

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Sabanci Baransel

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

September 1, 2022

Primary Completion

May 1, 2024

Study Completion

May 2, 2024

Last Updated

August 2, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

No individual participant data were not shared

Locations