- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06522126
The Effects of Progressive Relaxation Exercise
The Effects of Progressive Relaxation Exercise on Life Satisfaction, Anxiety, and Psychological Well-being in Students Experiencing Premenstrual Syndrome: A Randomized Controlled Trial
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey
- Esra Sabanci Baransel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: effects of progressive relaxation exercise
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.
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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.
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No Intervention: control groups
Control group standard care group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Premenstrual Syndrome Scale (PMSS)
Time Frame: 8 weeks
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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.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Life Satisfaction Scale (LSS)
Time Frame: 8 weeks
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The scale was developed by Diener et al.
Cronbach's alpha reliability coefficient of the scale was determined
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8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Anxiety Scale (BAS)
Time Frame: 8 weeks
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The scale was developed by Beck et al. to determine the incidence of anxiety and anxiety symptoms experienced by individuals.
The scoring of the measurement, which consists of 21 items, varies between 0-3.
The scale was adapted into Turkish by Ulusoy et al.
As a result of studies conducted with individuals presenting with psychological complaints
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8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022/3734
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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