SleepNCT05673213
Preterm Infants Physiological Parameters and Sleep-Wakefulness Status
A study testing Three-stair positioning pillows group in people with Sleep, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
This research was carried out between December 2021 and May 2022 as a randomized controlled experimental design. In the study, between 28-35 weeks of gestation preterm infants were divided into two groups as the experimental group (n=30) and the control group (n=30). Read more about this study
- Who is it for?
- Ages 28 to 35 weeksHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Three-stair positioning pillows group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 28 May 2022
- 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 28 to 35 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Only being diagnosed as preterm as a result of the examination performed by the physician,
- Parent's willingness to participate in the research,
- The infant is between 28-35 weeks of gestation,
- Being in appropriate weight according to the week of gestation,
- Having a history of intubation and being extubated.
Who cannot join
- Surgical procedure has been applied,
- Diagnosed with sepsis,
- Congenital anomaly,
- Taking analgesics 4 hours before, which may affect sleep,
- Having hyperbilirubinemia,
- Having hypoglycemia,
Show all 9Show fewer
- Presence of intracranial bleeding,
- Receiving any oxygen support (nasal O2, incubator O2, etc.),
- Intubated infants were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Three-Stair Positioning Pillows Used for Preterm Infants on Physiological Parameters and Sleep-Wakefulness Status
This research was carried out between December 2021 and May 2022 as a randomized controlled experimental design. In the study, between 28-35 weeks of gestation preterm infants were divided into two groups as the experimental group (n=30) and the control group (n=30). The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants in the control group were followed in the routine prone position of the neonatal intensive care unit, while infants in the experimental group were followed in the prone position with three-stair positioning pillows.
Read the detailed description
This research was carried a randomized controlled experimental design. The sample size in the study was 1.08, type 1 error was 5%, and statistical power was 95%, according to the power analysis performed by taking into account the Breathing frequency values of the groups in the study called "Effectiveness of Hammock Positioning in Reducing Pain and Improving Sleep-Wakefulness State in Preterm Infants". It was calculated as a total of 48 participants, 24 in each group (Ribas et al., 2019). Considering the possibility of losses, 30 preterm infants with TSPP (experimental) and 30 preterm infants who were not used (control) were included and the infants were randomly assigned to the groups. The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants were divided into 2 groups as 28-31 week gestation and 32-35 week gestation. 30 infants were randomly distributed to each gestational week group as experimental and control groups through a program available at http://www.randomizer.org. Families were informed by the researcher about the method of the study through face-to-face interviews, written and verbal consents were obtained, and the information about preterm infants and their families was recorded in the "Information Form". The actigraphy measuring device was connected to the computer and the device was installed by entering the parameters such as the name and surname of the infant to be treated and the time interval in which the recordings would be made. Data were collected from a single hall in the NICU. The noise level of the intensive care unit (NICU) was measured with the Uni-T UT353 Mini Decibelmeter Device and the average noise level of the hall where the data were collected was between 50-55 dB. The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Between these hours, the oxygen saturation and heart rate of the preterm infants in both groups were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. Preterm infants in the experimental group were followed in the prone position with three-stair positioning pillows and the infants in the control group were followed in the routine 15º head raised prone position between the hours of the research follow-up. The study followed the CONSORT guideline for reporting randomized controlled trials.
- Conditions
- Sleep
- Being tested
- Three-stair positioning pillows group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-stair positioning pillows groupOther
The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device.
| Study group | Role | What they receive |
|---|---|---|
| Routine 15º head raised prone position (control group) | No intervention | The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with routine 15º head raised prone position. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. |
| Three-stair positioning pillows group | Experimental | The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. Receives: Other: Three-stair positioning pillows group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Status/minute
Between 09:00-12:00
Measured: 3 hours
Wakefulness Status/minute
Measurements were made with an actigraphy device between 09:00 and 12:00.
Measured: 3 hours
Physiological Parameters (oxygen saturation /%)
Measurements were made with an actigraphy device between 09:00 and 12:00.
Measured: 3 hours
Physiological Parameters (heart rate/minute )
Between 09:00-12:00
Measured: 3 hours
Physiological Parameters (respiratory rate/minute )
Between 09:00-12:00
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Dec 2021
- Primary completion15 Mar 2022
- Study completion28 May 2022
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 SleepStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma BOZDAG, Harran University
- Investigators
- Fatma BOZDAĞ, Lecturer, Principal investigator, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673213
- Sponsor's protocol ID
- HRU-BOZDAG-002
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Unal T, Konuk Sener D. The Effect of Mother's Voice and Father's Voice Listened by Newborns During Heel Blood Collection on Pain Level and Physiological Parameters: A Randomized Controlled Study. J Perinat Neonatal Nurs. 2025 Jul-Sep 01;39(3):252-259. doi: 10.1097/JPN.0000000000000835. Epub 2025 Jul 22.
PubMed 39325982
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Three-Stair Positioning Pillows Used for Preterm Infants on Physiological Parameters and Sleep-Wakefulness Status
- ClinicalTrials.gov ID
- NCT05673213
- Acronym / sponsor ID
- HRU-BOZDAG-002
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 6 Jan 2023 (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 research was carried out between December 2021 and May 2022 as a randomized controlled experimental design. In the study, between 28-35 weeks of gestation preterm infants were divided into two groups as the experimental group (n=30) and the control group (n=30). The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants in the control group were followed in the routine prone position of the neonatal intensive care unit, while infants in the experimental group were followed in the prone position with three-stair positioning pillows.
Detailed description
This research was carried a randomized controlled experimental design. The sample size in the study was 1.08, type 1 error was 5%, and statistical power was 95%, according to the power analysis performed by taking into account the Breathing frequency values of the groups in the study called "Effectiveness of Hammock Positioning in Reducing Pain and Improving Sleep-Wakefulness State in Preterm Infants". It was calculated as a total of 48 participants, 24 in each group (Ribas et al., 2019). Considering the possibility of losses, 30 preterm infants with TSPP (experimental) and 30 preterm infants who were not used (control) were included and the infants were randomly assigned to the groups. The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants were divided into 2 groups as 28-31 week gestation and 32-35 week gestation. 30 infants were randomly distributed to each gestational week group as experimental and control groups through a program available at http://www.randomizer.org. Families were informed by the researcher about the method of the study through face-to-face interviews, written and verbal consents were obtained, and the information about preterm infants and their families was recorded in the "Information Form". The actigraphy measuring device was connected to the computer and the device was installed by entering the parameters such as the name and surname of the infant to be treated and the time interval in which the recordings would be made. Data were collected from a single hall in the NICU. The noise level of the intensive care unit (NICU) was measured with the Uni-T UT353 Mini Decibelmeter Device and the average noise level of the hall where the data were collected was between 50-55 dB. The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Between these hours, the oxygen saturation and heart rate of the preterm infants in both groups were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. Preterm infants in the experimental group were followed in the prone position with three-stair positioning pillows and the infants in the control group were followed in the routine 15º head raised prone position between the hours of the research follow-up. The study followed the CONSORT guideline for reporting randomized controlled trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine 15º head raised prone position (control group) | No intervention | –The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with routine 15º head raised prone position. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. |
| Three-stair positioning pillows group | Experimental | Other: Three-stair positioning pillows groupThe infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. |
Who may qualify
- Ages
- 28 to 35 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Only being diagnosed as preterm as a result of the examination performed by the physician,
- Parent's willingness to participate in the research,
- The infant is between 28-35 weeks of gestation,
- Being in appropriate weight according to the week of gestation,
- Having a history of intubation and being extubated.
Key exclusion criteria (9 listed)
- Surgical procedure has been applied,
- Diagnosed with sepsis,
- Congenital anomaly,
- Taking analgesics 4 hours before, which may affect sleep,
- Having hyperbilirubinemia,
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 |
|---|---|---|
| Three-stair positioning pillows groupThe infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Preterm infants were followed for 3 hours (09:00-12:00) with three-stair positioning pillows. Between these hours, the oxygen saturation and heart rate of the preterm infants in were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. | Other | Three-stair positioning pillows group |
Primary outcome
Sleep Status/minute
Time frame: 3 hours
Between 09:00-12:00
Wakefulness Status/minute
Time frame: 3 hours
Measurements were made with an actigraphy device between 09:00 and 12:00.
Physiological Parameters (oxygen saturation /%)
Time frame: 3 hours
Measurements were made with an actigraphy device between 09:00 and 12:00.
Physiological Parameters (heart rate/minute )
Time frame: 3 hours
Between 09:00-12:00
Physiological Parameters (respiratory rate/minute )
Time frame: 3 hours
Between 09:00-12:00
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 9 Jan 2023.
- Derived from this study: PubMed 39325982Unal T, Konuk Sener D. The Effect of Mother's Voice and Father's Voice Listened by Newborns During Heel Blood Collection on Pain Level and Physiological Parameters: A Randomized Controlled Study. J Perinat Neonatal Nurs. 2025 Jul-Sep 01;39(3):252-259. doi: 10.1097/JPN.0000000000000835. Epub 2025 Jul 22.
- 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.
Fatma BOZDAĞ, Lecturer principal investigator
Harran 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 Three-stair positioning pillows group in people with Sleep, run by Harran 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 5 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 9 Jan 2023. 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 Status/minute (time frame: 3 hours). The study lists 5 primary outcomes in all. 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 NCT05673213, 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 9 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.