Sleep QualityNCT07066124
Do Progressive Relaxation Exercises Affect the Sleep and Quality of Life of Pregnant Women?
A study testing Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks. in people with Sleep Quality and Quality of Life, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Quality of Life
- What is being tested?
- Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Development of any disease/complication during pregnancy
- Not regularly practicing PRE
- Not wishing to continue with the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar Üniversitesi Sağlık Bilimleri Fakültesi
Manisa, 45030
About this study
Official title: The Effect of Progressive Relaxation Exercises on Sleep Quality 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.
- Conditions
- Sleep Quality, Quality of Life
- Being tested
- Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks.
- Keywords
- Pregnancy, progressive relaxation exercise, sleep quality, quality of life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercises Group | Experimental | PRE training was given to the pregnant women in the intervention group and their practice was provided for six weeks. Receives: 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six weeks
Secondary outcomes (1)
Progressive relaxation exercises have a positive effect on the quality of life of pregnant women.
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.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Nov 2021
- Primary completion30 Sep 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozhan Tayhan, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066124
- Sponsor's protocol ID
- -Es-Ra!!Cbu
- Status last verified
- Aug 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Sleep Quality and Quality of Life of Pregnant Women
- ClinicalTrials.gov ID
- NCT07066124
- Acronym / sponsor ID
- -Es-Ra!!Cbu
- Conditions
- Sleep Quality, Quality of Life
- Keywords
- Pregnancy, progressive relaxation exercise, sleep quality, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises Group | Experimental | Behavioral: Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks.PRE training was given to the pregnant women in the intervention group and their practice was provided for six weeks. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks.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. | Behavioural | Exercises Group |
Primary outcome
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.
1 secondary outcome
Progressive relaxation exercises have a positive effect on the quality of life of pregnant women.
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercises training was given to the pregnant women in the intervention group and their practice was provided for six weeks. in people with Sleep Quality and Quality of Life, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive relaxation exercises have a positive effect on the sleep quality of pregnant women. (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.