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Completed

NCT Number: NCT06522126

The Effects of Progressive Relaxation Exercise

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Esra Sabanci Baransel

Malatya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive Relaxation Exercise

Behavioral

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.

Primary outcomes

  1. 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

  1. Life Satisfaction Scale (LSS)

    Time frame: 8 weeks

    The scale was developed by Diener et al. Cronbach's alpha reliability coefficient of the scale was determined

Other outcomes

  1. Beck Anxiety Scale (BAS)

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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