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Completed

NCT Number: NCT07066124

Do Progressive Relaxation Exercises Affect the Sleep and Quality of Life of Pregnant Women?

Aim: To examine the effects of progressive relaxation exercises (PRE) applied to pregnant women on sleep and life quality of pregnant women.

Methods: The research was carried out as a randomized controlled experimental study with pregnant women who applied to obstetrics clinics of a hospital. The research sample consisted of 66 pregnant women in the intervention and control groups. 'Pregnant Identification Form', 'Pittsburgh Sleep Quality Index' and Quality of Life Scale were applied to the pregnant women, and progressive relaxation exercises training was given to the pregnant women in the intervention group by randomization, and their practice was provided for six weeks. The control group received routine care. After the first encounter, Pittsburgh Sleep Quality Index and Quality of Life Scale were re-administered to the pregnant women in the third and sixth weeks to evaluate their sleep and quality of life. The data obtained were evaluated using the SPSS 15.0 program using descriptive statistics, chi-square cross tables, Independent simple t test, Repeated Measures test.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Celal Bayar Üniversitesi Sağlık Bilimleri Fakültesi

Manisa, 45030, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged between 18 and 35
  • Literate
  • Primiparous
  • Between 30-32 weeks of gestation
  • Owns a smartphone to listen to the music included in the exercise content
  • Willing to participate in the study

Exclusion criteria

  • Having a high-risk pregnancy (gestational diabetes, eclampsia, preeclampsia, threat of preterm birth, premature rupture of membranes, placental anomalies, etc.)
  • Conceiving through IVF (In Vitro Fertilization) treatment
  • Having a maternal physical anomaly
  • Experiencing communication difficulties or mental inadequacy
  • No history of mental illness in medical history
  • Detection of fetal anomalies during pregnancy
  • Development of any disease/complication during pregnancy
  • Not regularly practicing PRE
  • Not wishing to continue with the study

Treatment and study plan

Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks.

Behavioral

Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks. After the first encounter, Pittsburgh Sleep Quality Index and Quality of Life Scale were re-administered to the pregnant women in the third and sixth weeks to evaluate their sleep and quality of life.

Primary outcomes

  1. Progressive relaxation exercises have a positive effect on the sleep quality of pregnant women.

    Time frame: six weeks

    Progressive Relaxation Exercises (PRE) are breathing and stretching technique that helps relax nerves and muscles from hand to foot and, reduces sympathetic nervous system activity by stimulating the parasympathetic nervous system. It is thought that at the end of the PGE training given to pregnant women, learning PGE and applying it for six weeks will reduce the sleep problems that increase especially in the third trimester and thus increase their sleep and life quality. The PSQI evaluates sleep quality over the past month and consists of a total of 24 questions. The self-report questions cover various factors related to sleep quality, including estimates of sleep duration, sleep latency, and the frequency and severity of specific sleep-related issues. The scoring includes 18 items, grouped into 7 component scores. The sum of the component scores yields the total PSQI score, which ranges from 0 to 21. A total score greater than 5 indicates poor sleep quality.

Secondary outcomes

  1. Progressive relaxation exercises have a positive effect on the quality of life of pregnant women.

    Time frame: six weeks

    The SF-12 encompasses two different dimensions: Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS). Unlike the total score calculated for the SF-36, it is not used for the SF-12. In calculating the scale, the physical standardization values and mental standardization values for the answers given by individuals are added separately. Subsequently, for the 12 questions, 56.57706 is added to the physical standardization total to derive the physical components summary, and 60.75781 is added to the mental standardization total to derive the mental components summary. Both PCSS-12 and MCSS-12 scores range from 0 to 100, with higher scores representing better health. High scores indicate good health status. The Cronbach's alpha coefficients for the scale were found to be 0.73 for PCSS-12 and 0.72 for MCSS-12. In this study, the Cronbach's alpha coefficients were 0.69 for PCSS-12 and 0.71 for MCSS-12.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

The Effect of Progressive Relaxation Exercises on Sleep Quality and Quality of Life of Pregnant Women

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 15, 2025
Registry last updated
Aug 17, 2025

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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