Health Care Seeking BehaviorNCT05508542
Progressive Relaxation Exercises and Sleep, Anxiety and Stress in Risky Pregnants
A study testing Progressive relaxation exercises in people with Health Care Seeking Behavior, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Health Care Seeking Behavior
- What is being tested?
- Progressive relaxation exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2022to 30 Dec 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- At least primary school graduate,
- No communication problem,
- Not having any psychiatric disease,
- Diagnosed with a risky pregnancy for at least one month,
- In the last trimester of pregnancy,
- Having a smart phone,
- Internet access
Who cannot join
- Pregnant women diagnosed with restless legs syndrome during treatment and follow-up,
- Women who gave birth before the end of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Relaxation Exercises on Sleep Quality, Anxiety and Stress Levels in Risky Pregnants
This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women. "Personal Information Form", "Pittsburgh Sleep Quality Index (PUKI)" to measure the sleep quality of pregnant women, "Perinatal Anxiety Screening Scale" to determine the anxiety levels of pregnants, "Pregnancy Stress Scale" to determine the perceived stress level of pregnants, which were created by the researchers in the direction of the literature in data collection. Evaluation Scale".The universe of the research, T.C. It will consist of pregnant women who are hospitalized with the diagnosis of risky pregnancy in the Ministry of Health Adana City Training and Research Hospital Gynecology and Obstetrics Clinics. The sample size was determined as 15 patients to compare the means between the two groups. With an expected dropout rate of 10% and to ensure the adequacy of the final sample size, 17 patients were selected per group.Relaxation exercises are easy to apply, economical, safe and effective non-pharmacological applications that can be used independently by nurses and midwives. By ensuring the management of risky pregnancies, it will support the protection and development of public health by ensuring the protection of both women and fetus health.
Read the detailed description
This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women.
H1-1: There is a significant difference between the sleep quality posttest total score averages.
H1-2: There is a significant difference between the anxiety level posttest total score averages.
H1-3: There is a significant difference between the stress level posttest total score averages.
The universe of the research, T.C. It will consist of pregnant women who are hospitalized with the diagnosis of risky pregnancy in the Ministry of Health Adana City Training and Research Hospital Gynecology and Obstetrics Clinics. "Personal Information Form", "Pittsburgh Sleep Quality Index (PUKI)" to measure the sleep quality of pregnant women, "Perinatal Anxiety Screening Scale" to determine the anxiety levels of pregnants, "Pregnancy Stress Scale" to determine the perceived stress level of pregnants, which were created by the researchers in the direction of the literature in data collection. Evaluation Scale".Intervention Group The pregnant women who were diagnosed with a risky pregnancy, admitted to the clinic and met the research participation criteria will be informed about the study by the researchers, and verbal and written consents of the pregnant women who accepted to participate in the study will be obtained and the study will begin.
Personal information form, Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied to the pregnant women at the first interview. Afterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. Afterwards, the Relaxation Exercises CD will be played and the exercises will be performed with the patient along with the CD. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient.
After these trainings are completed, a booklet will be given to the patients that will contribute to the correct practice of relaxation exercises on their own. Patients will be asked to practice relaxation exercises by listening to the programs downloaded to their phones at least three times a week for 4 weeks. Researchers will follow the patients over the phone for 4 weeks.
In the final test phase; Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be re-administered 4 weeks after the start of exercise practices.
Control Group In the control group, pregnant women who meet the research participation criteria will be informed about the study by the researchers, verbal and written consents of the pregnant women who accepted to participate in the study will be obtained and data collection will begin.
The control group will receive routine nursing care in the clinic and no intervention will be made to this group. Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied at the first interview.
In the post-test phase, 4 weeks after the start of the first interview, the Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be administered again.
In order to prevent the pregnant women in the control group from being affected by the pregnant women in the intervention group, pregnant women in different rooms will be selected for the intervention and control group.Progressive relaxation exercises are a non-pharmacological method that can be easily applied by both nurses and pregnant women in the management of life-threatening risky pregnancies for maternal and fetal health. Improving the sleep quality of pregnant women, reducing perceived stress and anxiety levels will increase their quality of life. By ensuring the management of risky pregnancies, it will support the protection and development of public health by ensuring the protection of both women and fetus health. The work done in this area is limited. At the end of the study, it is thought that it will contribute to the literature.
- Conditions
- Health Care Seeking Behavior
- Being tested
- Progressive relaxation exercises
- Keywords
- risky pregnancy, progressive relaxation exercises, anxiety, stress, nursing
- Medical subject headings
- Patient Acceptance of Health Care, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercisesBehavioural
Personal information form, Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied to the pregnant women at the first interview. Afterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. Afterwards, the Relaxation Exercises CD will be played and the exercises will be performed with the patient along with the CD. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Progressive relaxation exercises | Experimental | Afterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient.
After these trainings are completed, a booklet will be given to the patients that will contribute to the correct practice of relaxation exercises on their own. Patients will be asked to practice relaxation exercises by listening to the programs downloaded to their phones at least three times a week for 4 weeks.
In the final test phase; Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be re-administered 4 weeks after the start of exercise practices. Receives: Behavioral: Progressive relaxation exercises |
| No Intervention: Standard care group | No intervention | Standard care group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PUKI)
It was developed by Buysse et al. in 1989 (Buysse et al., 1989). The Turkish validity and reliability study of the scale was conducted by Ağargün et al. (1996) and the Cronbach Alpha internal consistency coefficient was found to be 0.80.A total score higher than 5 indicates poor sleep quality .
Measured: change in sleep quality at four weeks
Secondary outcomes (1)
Prenatal Anxiety Screening Scale
It was developed by Somerville et al. in 2013 and validated and reliable in 2019 by Yazıcı et al. The scale consists of 31 items. The four sub-dimensions of the scale are: (1) acute anxiety and adjustment disorder, (2) general anxiety and specific fears, (3) perfectionism, control and trauma, and (4) social anxiety. Cronbach Alpha was found to be 0.95. The cut-off point on the original scale was calculated as 26, minimum anxiety symptoms 0-20, mild-moderate 21-41, and severe anxiety 42-93
Measured: change in anxiety level at four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start18 Aug 2022
- Primary completion21 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health Care Seeking BehaviorStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra ÇERÇER, Cukurova University
- Investigators
- Zehra ÇERÇER, PhD, Principal investigator, Cukurova UniversityEvşen NAZİK, Prof. Dr., Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508542
- Sponsor's protocol ID
- 34
- Status last verified
- Jan 2026
- First submitted
- 18 Aug 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Somerville S, Dedman K, Hagan R, Oxnam E, Wettinger M, Byrne S, Coo S, Doherty D, Page AC. The Perinatal Anxiety Screening Scale: development and preliminary validation. Arch Womens Ment Health. 2014 Oct;17(5):443-54. doi: 10.1007/s00737-014-0425-8. Epub 2014 Apr 4.
PubMed 24699796Akmese ZB, Oran NT. Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy. J Midwifery Womens Health. 2014 Sep-Oct;59(5):503-9. doi: 10.1111/jmwh.12176. Epub 2014 Jun 25.
PubMed 24965313
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises on Sleep Quality, Anxiety and Stress Levels in Risky Pregnants
- ClinicalTrials.gov ID
- NCT05508542
- Acronym / sponsor ID
- 34
- Conditions
- Health Care Seeking Behavior
- Keywords
- risky pregnancy, progressive relaxation exercises, anxiety, stress, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 19 Aug 2022 (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.
This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women. "Personal Information Form", "Pittsburgh Sleep Quality Index (PUKI)" to measure the sleep quality of pregnant women, "Perinatal Anxiety Screening Scale" to determine the anxiety levels of pregnants, "Pregnancy Stress Scale" to determine the perceived stress level of pregnants, which were created by the researchers in the direction of the literature in data collection. Evaluation Scale".The universe of the research, T.C. It will consist of pregnant women who are hospitalized with the diagnosis of risky pregnancy in the Ministry of Health Adana City Training and Research Hospital Gynecology and Obstetrics Clinics. The sample size was determined as 15 patients to compare the means between the two groups. With an expected dropout rate of 10% and to ensure the adequacy of the final sample size, 17 patients were selected per group.Relaxation exercises are easy to apply, economical, safe and effective non-pharmacological applications that can be used independently by nurses and midwives. By ensuring the management of risky pregnancies, it will support the protection and development of public health by ensuring the protection of both women and fetus health.
Detailed description
This study was planned as a randomized controlled quasi-experimental study to determine the effect of progressive relaxation exercises on sleep quality, anxiety and stress levels in risky pregnant women.
H1-1: There is a significant difference between the sleep quality posttest total score averages.
H1-2: There is a significant difference between the anxiety level posttest total score averages.
H1-3: There is a significant difference between the stress level posttest total score averages.
The universe of the research, T.C. It will consist of pregnant women who are hospitalized with the diagnosis of risky pregnancy in the Ministry of Health Adana City Training and Research Hospital Gynecology and Obstetrics Clinics. "Personal Information Form", "Pittsburgh Sleep Quality Index (PUKI)" to measure the sleep quality of pregnant women, "Perinatal Anxiety Screening Scale" to determine the anxiety levels of pregnants, "Pregnancy Stress Scale" to determine the perceived stress level of pregnants, which were created by the researchers in the direction of the literature in data collection. Evaluation Scale".Intervention Group The pregnant women who were diagnosed with a risky pregnancy, admitted to the clinic and met the research participation criteria will be informed about the study by the researchers, and verbal and written consents of the pregnant women who accepted to participate in the study will be obtained and the study will begin.
Personal information form, Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied to the pregnant women at the first interview. Afterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. Afterwards, the Relaxation Exercises CD will be played and the exercises will be performed with the patient along with the CD. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient.
After these trainings are completed, a booklet will be given to the patients that will contribute to the correct practice of relaxation exercises on their own. Patients will be asked to practice relaxation exercises by listening to the programs downloaded to their phones at least three times a week for 4 weeks. Researchers will follow the patients over the phone for 4 weeks.
In the final test phase; Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be re-administered 4 weeks after the start of exercise practices.
Control Group In the control group, pregnant women who meet the research participation criteria will be informed about the study by the researchers, verbal and written consents of the pregnant women who accepted to participate in the study will be obtained and data collection will begin.
The control group will receive routine nursing care in the clinic and no intervention will be made to this group. Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied at the first interview.
In the post-test phase, 4 weeks after the start of the first interview, the Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be administered again.
In order to prevent the pregnant women in the control group from being affected by the pregnant women in the intervention group, pregnant women in different rooms will be selected for the intervention and control group.Progressive relaxation exercises are a non-pharmacological method that can be easily applied by both nurses and pregnant women in the management of life-threatening risky pregnancies for maternal and fetal health. Improving the sleep quality of pregnant women, reducing perceived stress and anxiety levels will increase their quality of life. By ensuring the management of risky pregnancies, it will support the protection and development of public health by ensuring the protection of both women and fetus health. The work done in this area is limited. At the end of the study, it is thought that it will contribute to the literature.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Progressive relaxation exercises | Experimental | Behavioral: Progressive relaxation exercisesAfterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient. After these trainings are completed, a booklet will be given to the patients that will contribute to the correct practice of relaxation exercises on their own. Patients will be asked to practice relaxation exercises by listening to the programs downloaded to their phones at least three times a week for 4 weeks. In the final test phase; Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be re-administered 4 weeks after the start of exercise practices. |
| No Intervention: Standard care group | No intervention | –Standard care group. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- At least primary school graduate,
- No communication problem,
- Not having any psychiatric disease,
- Diagnosed with a risky pregnancy for at least one month,
- In the last trimester of pregnancy,
Key exclusion criteria (2 listed)
- Pregnant women diagnosed with restless legs syndrome during treatment and follow-up,
- Women who gave birth before the end of the study.
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 exercisesPersonal information form, Pittsburgh Sleep Quality Index (PUKI), Prenatal Anxiety Screening Scale and Pregnancy Stress Rating Scale will be applied to the pregnant women at the first interview. Afterwards, the researcher will first give training on progressive relaxation exercises to the patient in the patient's room. Afterwards, the Relaxation Exercises CD will be played and the exercises will be performed with the patient along with the CD. A relaxation exercise program will be installed on the patients' phones via the Whatsapp application. It is planned that the trainings will be applied to the patients one-to-one and will last an average of 40-45 minutes for each patient. | Behavioural | Intervention group: Progressive relaxation exercises |
Primary outcome
Pittsburgh Sleep Quality Index (PUKI)
Time frame: change in sleep quality at four weeks
It was developed by Buysse et al. in 1989 (Buysse et al., 1989). The Turkish validity and reliability study of the scale was conducted by Ağargün et al. (1996) and the Cronbach Alpha internal consistency coefficient was found to be 0.80.A total score higher than 5 indicates poor sleep quality .
1 secondary outcome
Prenatal Anxiety Screening Scale
Time frame: change in anxiety level at four 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 16 Jan 2026.
- Background: PubMed 24699796Somerville S, Dedman K, Hagan R, Oxnam E, Wettinger M, Byrne S, Coo S, Doherty D, Page AC. The Perinatal Anxiety Screening Scale: development and preliminary validation. Arch Womens Ment Health. 2014 Oct;17(5):443-54. doi: 10.1007/s00737-014-0425-8. Epub 2014 Apr 4.
- Background: PubMed 24965313Akmese ZB, Oran NT. Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy. J Midwifery Womens Health. 2014 Sep-Oct;59(5):503-9. doi: 10.1111/jmwh.12176. Epub 2014 Jun 25.
- 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.
Zehra ÇERÇER, PhD principal investigator
Cukurova University
Evşen NAZİK, Prof. Dr. study director
Cukurova University
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 in people with Health Care Seeking Behavior, run by Cukurova 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 7 inclusion and 2 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 16 Jan 2026. 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?
Pittsburgh Sleep Quality Index (PUKI) (time frame: change in sleep quality at four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508542, which also lists 2 linked publications.
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 16 Jan 2026.