Pregnancy RelatedNCT04262349
The Effect of the Training Program on Increasing Sleep Quality in Pregnancy to Maternal Sleep Quality
A study testing sleep education in people with Pregnancy Related, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the control group and the intervention to be applied to the education program used to increase sleep quality in nulliparous women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- sleep education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2018to 30 Dec 2020
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women
- between 28 and 32 gestational weeks
Who cannot join
- under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Training Program on Sleep Quality
The aim of this study is to compare the control group and the intervention to be applied to the education program used to increase sleep quality in nulliparous women.
Read the detailed description
The study was a randomized controlled training intervention study in the pre-test and post-test order. The population of the study consisted of nulliparous pregnant women who applied to the Konya Dr. Ali Kemal Belviranlı Maternity and Children Hospital Pregnancy School and met the criteria for inclusion in the study at time of the study. Sample size was calculated with G * Power 3.0.10 program with an effect size of 0.3 (medium effect level) and a power of 80%. A total of 180 pregnant women were identified as 90 in the intervention group and 90 in the control group. Considering that data will be lost due to reasons such as discontinuation and exclusion criteria during pregnancy 10% more of the determined number was included in the study and the sample size was calculated as 198 pregnant women and 252 pregnant women were reached during the study. 36 pregnant women in the intervention group and 35 pregnant women in the control group were excluded from the study for different reasons and the study was completed with 181 pregnant women (90: control: 91). The groups were determined by randomization. During the conduct of the study, all pregnant women who applied to the pregnant school and met the criteria for participation in the study were recorded in the pre-training registry and numbered in the order of registration. Every week because of differences in the number of pregnant women who attended the school participating women were divided into two groups using a random number table created in the program via the computer itself. The purpose of the study was explained to pregnant women, informed consent form and data collection tools of the study were collected by face to face interview technique. In the first interview to all pregnant women; Personal Information Form, Course Information Form, Pittshburg Sleep Quality Index (PUKI) and General Self-Efficacy Scale were applied. Pregnant women in the intervention group were given a two-session training program to improve sleep quality and "Sleep Guide" and "Safe Baby Sleep Conditions Brochure". Pregnant women in the control group were subjected to routine practice without any training given by the researcher. Four weeks after the completion of the sleep training, all pregnant women were contacted by telephone and the data collection tools were applied for the second time and the final test applications were completed. After completion of the data collection process made a new plan for training to improve the quality of sleep to pregnant women in the control group and the "Sleep Guide" and "Safe Baby Sleep Conditions Brochure" is given.
- Conditions
- Pregnancy Related
- Being tested
- sleep education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep educationBehavioural
As a training program to increase sleep, pregnant women will be given 2 training sessions per week for two weeks and four sessions in total for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Every week because of differences in the number of pregnant women who attended the school participating women were divided into two groups using a random number table created in the program via the computer itself. The purpose of the study was explained to pregnant women, informed consent form and data collection tools of the study were collected by face to face interview technique. In the first interview to all pregnant women; Personal Information Form, Course Information Form, Pittshburg Sleep Quality Index (PUKI) and General Self-Efficacy Scale were applied. Pregnant women in the intervention group were given a two-session training program to improve sleep quality and "Sleep Guide" and "Safe Baby Sleep Conditions Brochure". Receives: Behavioral: sleep education |
| control | No intervention | Pregnant women in the control group were subjected to routine practice without any training given by the researcher. Four weeks after the completion of the sleep training, all pregnant women were contacted by telephone and the data collection tools were applied for the second time and the final test applications were completed. After completion of the data collection process made a new plan for training to improve the quality of sleep to pregnant women in the control group and the "Sleep Guide" and "Safe Baby Sleep Conditions Brochure" is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Pittshburg Sleep Quality Index (PUKI):
PUKI is a self-report scale that evaluates sleep quality and disorders in the past month.
It consists of 24 questions in total, 19 of which are self-report based questions.
The last 5 questions are not included in the scoring, they are used for clinical evaluation.
Each item of the scale is evaluated as 0-3 points.
Seven "component" scores are created from nineteen items. While some components consist of evaluating a single substance, some components are the result of combining several items.
Components that make up the scale; subjective sleep quality, sleep delay, sleep duration, habitual sleep effectiveness, sleep disorders, use of sleeping pills and daytime dysfunction.
The scale total score is obtained by calculating the points of these seven components and the maximum scale score that can be obtained is 21.
Increased score indicates poor sleep quality.
A total scale score of 5 and above is expressed as bad sleep.
Measured: change in sleep quality in the 4th week of education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start30 Dec 2018
- Primary completion30 Jun 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Ege 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- : The study was a randomized controlled training intervention study. Sample size was calculated with G \* Power 3.0.10 program with an effect size of 0.3 (medium effect level) and a power of 80%. A total of 180 pregnant women were identified as 90 in the intervention group and 90 in the control group. Considering that data will be lost due to reasons such as discontinuation and exclusion criteria during pregnancy 10% more of the determined number was included in the study and the sample size was calculated as 198 pregnant women and 252 pregnant women were reached during the study. 36 pregnant women in the intervention group and 35 pregnant women in the control group were excluded from the study for different reasons and the study was completed with 181 pregnant women (90: control: 91). The groups were determined by randomization.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe BAY, Ege University
- Investigators
- Neriman Soğukpınar, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262349
- Sponsor's protocol ID
- 0000-0001-5786-4385
- Status last verified
- Sep 2022
- First submitted
- 5 Feb 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bay Ozcalik H, Sogukpinar N. The Effect of Sleep Enhancement Educational Program on Maternal Sleep Quality for Nulliparous Pregnant Women: A Randomized-Controlled Trial. Int J Behav Med. 2025 Feb;32(1):11-20. doi: 10.1007/s12529-024-10261-x. Epub 2024 Jan 29.
PubMed 38286916
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Training Program on Sleep Quality
- ClinicalTrials.gov ID
- NCT04262349
- Acronym / sponsor ID
- 0000-0001-5786-4385
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 30 Dec 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 10 Feb 2020 (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.
The aim of this study is to compare the control group and the intervention to be applied to the education program used to increase sleep quality in nulliparous women.
Detailed description
The study was a randomized controlled training intervention study in the pre-test and post-test order. The population of the study consisted of nulliparous pregnant women who applied to the Konya Dr. Ali Kemal Belviranlı Maternity and Children Hospital Pregnancy School and met the criteria for inclusion in the study at time of the study. Sample size was calculated with G * Power 3.0.10 program with an effect size of 0.3 (medium effect level) and a power of 80%. A total of 180 pregnant women were identified as 90 in the intervention group and 90 in the control group. Considering that data will be lost due to reasons such as discontinuation and exclusion criteria during pregnancy 10% more of the determined number was included in the study and the sample size was calculated as 198 pregnant women and 252 pregnant women were reached during the study. 36 pregnant women in the intervention group and 35 pregnant women in the control group were excluded from the study for different reasons and the study was completed with 181 pregnant women (90: control: 91). The groups were determined by randomization. During the conduct of the study, all pregnant women who applied to the pregnant school and met the criteria for participation in the study were recorded in the pre-training registry and numbered in the order of registration. Every week because of differences in the number of pregnant women who attended the school participating women were divided into two groups using a random number table created in the program via the computer itself. The purpose of the study was explained to pregnant women, informed consent form and data collection tools of the study were collected by face to face interview technique. In the first interview to all pregnant women; Personal Information Form, Course Information Form, Pittshburg Sleep Quality Index (PUKI) and General Self-Efficacy Scale were applied. Pregnant women in the intervention group were given a two-session training program to improve sleep quality and "Sleep Guide" and "Safe Baby Sleep Conditions Brochure". Pregnant women in the control group were subjected to routine practice without any training given by the researcher. Four weeks after the completion of the sleep training, all pregnant women were contacted by telephone and the data collection tools were applied for the second time and the final test applications were completed. After completion of the data collection process made a new plan for training to improve the quality of sleep to pregnant women in the control group and the "Sleep Guide" and "Safe Baby Sleep Conditions Brochure" is given.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- : The study was a randomized controlled training intervention study. Sample size was calculated with G * Power 3.0.10 program with an effect size of 0.3 (medium effect level) and a power of 80%. A total of 180 pregnant women were identified as 90 in the intervention group and 90 in the control group. Considering that data will be lost due to reasons such as discontinuation and exclusion criteria during pregnancy 10% more of the determined number was included in the study and the sample size was calculated as 198 pregnant women and 252 pregnant women were reached during the study. 36 pregnant women in the intervention group and 35 pregnant women in the control group were excluded from the study for different reasons and the study was completed with 181 pregnant women (90: control: 91). The groups were determined by randomization.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: sleep educationEvery week because of differences in the number of pregnant women who attended the school participating women were divided into two groups using a random number table created in the program via the computer itself. The purpose of the study was explained to pregnant women, informed consent form and data collection tools of the study were collected by face to face interview technique. In the first interview to all pregnant women; Personal Information Form, Course Information Form, Pittshburg Sleep Quality Index (PUKI) and General Self-Efficacy Scale were applied. Pregnant women in the intervention group were given a two-session training program to improve sleep quality and "Sleep Guide" and "Safe Baby Sleep Conditions Brochure". |
| control | No intervention | –Pregnant women in the control group were subjected to routine practice without any training given by the researcher. Four weeks after the completion of the sleep training, all pregnant women were contacted by telephone and the data collection tools were applied for the second time and the final test applications were completed. After completion of the data collection process made a new plan for training to improve the quality of sleep to pregnant women in the control group and the "Sleep Guide" and "Safe Baby Sleep Conditions Brochure" is given. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant women
- between 28 and 32 gestational weeks
Key exclusion criteria (1 listed)
- under 18 years old
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 |
|---|---|---|
| sleep educationAs a training program to increase sleep, pregnant women will be given 2 training sessions per week for two weeks and four sessions in total for 60 minutes. | Behavioural | intervention |
Primary outcome
Sleep Quality
Time frame: change in sleep quality in the 4th week of education
Pittshburg Sleep Quality Index (PUKI): PUKI is a self-report scale that evaluates sleep quality and disorders in the past month. It consists of 24 questions in total, 19 of which are self-report based questions. The last 5 questions are not included in the scoring, they are used for clinical evaluation. Each item of the scale is evaluated as 0-3 points. Seven "component" scores are created from nineteen items. While some components consist of evaluating a single substance, some components are the result of combining several items. Components that make up the scale; subjective sleep quality, sleep delay, sleep duration, habitual sleep effectiveness, sleep disorders, use of sleeping pills and daytime dysfunction. The scale total score is obtained by calculating the points of these seven components and the maximum scale score that can be obtained is 21. Increased score indicates poor sleep quality. A total scale score of 5 and above is expressed as bad sleep.
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 13 Sep 2022.
- Derived from this study: PubMed 38286916Bay Ozcalik H, Sogukpinar N. The Effect of Sleep Enhancement Educational Program on Maternal Sleep Quality for Nulliparous Pregnant Women: A Randomized-Controlled Trial. Int J Behav Med. 2025 Feb;32(1):11-20. doi: 10.1007/s12529-024-10261-x. Epub 2024 Jan 29.
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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.
Neriman Soğukpınar study director
Ege 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 sleep education in people with Pregnancy Related, run by Ege 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 2 inclusion and 1 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 13 Sep 2022. 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?
Sleep Quality (time frame: change in sleep quality in the 4th week of education). 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 NCT04262349, which also lists 1 linked publication.
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 13 Sep 2022.