NCT07066124

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

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

November 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

April 10, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

Pregnancyprogressive relaxation exercisesleep qualityquality of life

Outcome Measures

Primary Outcomes (1)

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

    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.

    six weeks

Secondary Outcomes (1)

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

    six weeks

Study Arms (2)

Exercises Group

EXPERIMENTAL

PRE 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.

Control Group

NO INTERVENTION

Interventions

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.

Exercises Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar Üniversitesi Sağlık Bilimleri Fakültesi

Manisa, 45030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 10, 2025

First Posted

July 15, 2025

Study Start

November 1, 2021

Primary Completion

September 30, 2022

Study Completion

February 20, 2023

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations