Sleep QualityAISSNCT07284303
Infant Swing and Sleep-Wake Cycles
A study testing Care: Automatic Baby Swing in people with Sleep Quality, run by Kirsehir Ahi Evran Universitesi.
Trial summary
This study was planned to determine the effects of automatic baby swing application on the sleep-wake cycle, comfort behaviors and physiological parameters of babies in the neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages 35 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Care: Automatic Baby Swing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational age between 35-42 weeks,
- birth weight >2000-4200 grams,
- stable health status,
- spontaneous breathing,
- no sedation,
- parental volunteering to participate in the study.
Who cannot join
- - A 5-minute APGAR score below 4 at birth,
- Requirement of resuscitation,
- Presence of a congenital anomaly,
- Requirement of interventional intervention in the head region,
- Presence of central nervous system dysfunction,
- Presence of postpartum medical complications.
- Sudden need for resuscitation Sudden deterioration of the stabilization of health status
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of an Automatic Infant Swing on Sleep-Wake Cycles, Comfort Behaviors, and Physiological Parameters in Newborns: A Randomized Controlled Trial
This study was planned to determine the effects of automatic baby swing application on the sleep-wake cycle, comfort behaviors and physiological parameters of babies in the neonatal intensive care unit.
Read the detailed description
Sleep patterns and behavioral comfort during the neonatal period are important indicators of neurological development and physiological stability. However, noise, light, and constant medical interventions and care practices in the NICU environment can negatively affect infants' sleep continuity and quality of rest. Therefore, non-pharmacological approaches that provide sensory support, such as rhythmic and gentle rocking, are thought to be effective in promoting infant relaxation and physiological balance. In this study, an automatic baby swing with adjustable speed and rhythm will be used as an intervention to support infant comfort and sleep organization. Clinically stable term and preterm newborns who meet the specified inclusion criteria will be included in the study. Participants will be randomly assigned to two groups: the intervention group (first automatic swing application, then measurement without the swing) and the control group (first measurement without the swing, then measurement in the automatic baby swing). The intervention will be implemented for 60 minutes after daytime care at 9:00 AM and 12:00 PM, and for 60 minutes after nighttime care at 9:00 PM and 12:00 AM. The infants' BIS values, comfort, and physiological parameters will be monitored throughout the entire process. The study will evaluate the infants' sleep-wake cycles, comfort behaviors (e.g., facial expressions, body movements, crying), and physiological parameters (e.g., heart rate, respiratory rate, oxygen saturation) as outcome variables. Data will be collected using standardized observation forms and monitoring devices. This study is expected to contribute to evidence-based nursing practice by demonstrating the effects of movement-based nonpharmacological interventions on newborn comfort, sleep quality, and physiological stability.
- Conditions
- Sleep Quality
- Being tested
- Care: Automatic Baby Swing
- Keywords
- Bispectral Index, Comfort, Infant Swing, Newborn, Randomized Controlled Trial, Sleep-Wake Cycle
- 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.
Care: Automatic Baby SwingOther
The Automatic Baby Swing aims to calm the baby by mimicking their natural movements. In this study, the low-speed "Rock-a-Bye" mode will be used because it mimics natural parental movements, making it easier for babies to fall asleep. During the implementation phase: After the baby's general condition is checked, the treatment will begin according to the group to which they were randomly assigned. If the baby is assigned to the Automatic Baby Swing, their sleep, comfort, and physiological parameters will be measured "First in the Automatic Baby Swing, Then in the Incubator" for 60 minutes during the day and night. If the baby is assigned to the other group, their sleep, comfort, and physiological parameters will be measured "First in the Incubator, Then in the Automatic Baby Swing" for 60 minutes during the day and night.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1: Automatic Baby Swing, Then Incubator | Experimental | The sleep, comfort, and physiological parameters of the babies in Group 1 will be assessed day and night, "First in the Automatic Baby Swing, Then in the Incubator." Receives: Other: Care: Automatic Baby Swing |
| Intervention Group 2: Incubator, Then in the Automatic Baby Swing | Experimental | The sleep, comfort, and physiological parameters of the babies in Group 2 will be assessed day and night, "First in the Incubator, Then in the Automatic Baby Swing." Receives: Other: Care: Automatic Baby Swing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1: COMFORTneo Total Score
The COMFORTneo scale assesses seven behavioral and physiological parameters (muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying). These parameters will be combined to produce a single total score (range 6-30). Only the total score will be reported.
Measured: At 0, 30, and 60 minutes.
Secondary outcomes (5)
Secondary Outcome 1: Infant Body Temperature
Infant axillary body temperature measured in degrees Celsius (°C).
Measured: At 0, 30, and 60 minutes.
Secondary Outcome 2: Infant Heart Rate
Infant heart rate measured in beats per minute.
Measured: At 0, 30, and 60 minutes.
Secondary Outcome 3: Infant Respiratory Rate
Infant respiratory rate measured in breaths per minute.
Measured: At 0, 30, and 60 minutes.
Secondary Outcome 4: Infant Oxygen Saturation
Pulse oximetry oxygen saturation measured as %SpO₂.
Measured: At 0, 30, and 60 minutes.
Secondary Outcome 5: Infant Blood Pressure
Non-invasive systolic and diastolic blood pressure measured in mmHg.
Measured: At 0, 30, and 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- This study is a randomized, controlled, single-blind, two-period crossover trial conducted in a neonatal intensive care unit (NICU) in Central Anatolia, Türkiye. The study population consists of late preterm and term infants (35-42 weeks of gestation) who meet the inclusion criteria. Infants will be randomly assigned to two groups (Group A and Group B) using block randomization performed by an independent statistician. Each infant will experience both conditions - automatic swing (intervention) and standard crib (control) - in different periods according to the crossover design. The study follows the CONSORT 2010 guidelines for randomized crossover trials.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edanur Tar Bolacali, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284303
- Sponsor's protocol ID
- SELCUK-2025-INFANTSWING
- Acronym
- AISS
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.
PubMed 31397094van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
PubMed 19692803Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
PubMed 34713833Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378.
PubMed 31366597Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
PubMed 35634367Bolacali ET, Erturk F, Ozcan B, Kucukoglu S. Effect of Automatic Infant Swing on Sleep-Wake Cycles and Comfort: A Randomized Controlled Study Protocol. Nurs Crit Care. 2026 Jul;31(4):e70570. doi: 10.1111/nicc.70570.
PubMed 42429091
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Automatic Infant Swing on Sleep-Wake Cycles, Comfort Behaviors, and Physiological Parameters in Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07284303
- Acronym / sponsor ID
- AISS / SELCUK-2025-INFANTSWING
- Conditions
- Sleep Quality
- Keywords
- Bispectral Index, Comfort, Infant Swing, Newborn, Randomized Controlled Trial, Sleep-Wake Cycle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 16 Dec 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.
This study was planned to determine the effects of automatic baby swing application on the sleep-wake cycle, comfort behaviors and physiological parameters of babies in the neonatal intensive care unit.
Detailed description
Sleep patterns and behavioral comfort during the neonatal period are important indicators of neurological development and physiological stability. However, noise, light, and constant medical interventions and care practices in the NICU environment can negatively affect infants' sleep continuity and quality of rest. Therefore, non-pharmacological approaches that provide sensory support, such as rhythmic and gentle rocking, are thought to be effective in promoting infant relaxation and physiological balance. In this study, an automatic baby swing with adjustable speed and rhythm will be used as an intervention to support infant comfort and sleep organization. Clinically stable term and preterm newborns who meet the specified inclusion criteria will be included in the study. Participants will be randomly assigned to two groups: the intervention group (first automatic swing application, then measurement without the swing) and the control group (first measurement without the swing, then measurement in the automatic baby swing). The intervention will be implemented for 60 minutes after daytime care at 9:00 AM and 12:00 PM, and for 60 minutes after nighttime care at 9:00 PM and 12:00 AM. The infants' BIS values, comfort, and physiological parameters will be monitored throughout the entire process. The study will evaluate the infants' sleep-wake cycles, comfort behaviors (e.g., facial expressions, body movements, crying), and physiological parameters (e.g., heart rate, respiratory rate, oxygen saturation) as outcome variables. Data will be collected using standardized observation forms and monitoring devices. This study is expected to contribute to evidence-based nursing practice by demonstrating the effects of movement-based nonpharmacological interventions on newborn comfort, sleep quality, and physiological stability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, controlled, single-blind, two-period crossover trial conducted in a neonatal intensive care unit (NICU) in Central Anatolia, Türkiye. The study population consists of late preterm and term infants (35-42 weeks of gestation) who meet the inclusion criteria. Infants will be randomly assigned to two groups (Group A and Group B) using block randomization performed by an independent statistician. Each infant will experience both conditions - automatic swing (intervention) and standard crib (control) - in different periods according to the crossover design. The study follows the CONSORT 2010 guidelines for randomized crossover trials.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1: Automatic Baby Swing, Then Incubator | Experimental | Other: Care: Automatic Baby SwingThe sleep, comfort, and physiological parameters of the babies in Group 1 will be assessed day and night, "First in the Automatic Baby Swing, Then in the Incubator." |
| Intervention Group 2: Incubator, Then in the Automatic Baby Swing | Experimental | Other: Care: Automatic Baby SwingThe sleep, comfort, and physiological parameters of the babies in Group 2 will be assessed day and night, "First in the Incubator, Then in the Automatic Baby Swing." |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- gestational age between 35-42 weeks,
- birth weight >2000-4200 grams,
- stable health status,
- spontaneous breathing,
- no sedation,
Key exclusion criteria (7 listed)
- - A 5-minute APGAR score below 4 at birth,
- Requirement of resuscitation,
- Presence of a congenital anomaly,
- Requirement of interventional intervention in the head region,
- Presence of central nervous system dysfunction,
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 |
|---|---|---|
| Care: Automatic Baby SwingThe Automatic Baby Swing aims to calm the baby by mimicking their natural movements. In this study, the low-speed "Rock-a-Bye" mode will be used because it mimics natural parental movements, making it easier for babies to fall asleep. During the implementation phase: After the baby's general condition is checked, the treatment will begin according to the group to which they were randomly assigned. If the baby is assigned to the Automatic Baby Swing, their sleep, comfort, and physiological parameters will be measured "First in the Automatic Baby Swing, Then in the Incubator" for 60 minutes during the day and night. If the baby is assigned to the other group, their sleep, comfort, and physiological parameters will be measured "First in the Incubator, Then in the Automatic Baby Swing" for 60 minutes during the day and night. | Other | Intervention Group 1: Automatic Baby Swing, Then Incubator, Intervention Group 2: Incubator, Then in the Automatic Baby Swing |
Primary outcome
Primary Outcome 1: COMFORTneo Total Score
Time frame: At 0, 30, and 60 minutes.
The COMFORTneo scale assesses seven behavioral and physiological parameters (muscle tone, alertness, facial tension, calmness/agitation, body movements, respiratory response, and crying). These parameters will be combined to produce a single total score (range 6-30). Only the total score will be reported.
5 secondary outcomes
Secondary Outcome 1: Infant Body Temperature
Time frame: At 0, 30, and 60 minutes.
Secondary Outcome 2: Infant Heart Rate
Time frame: At 0, 30, and 60 minutes.
Secondary Outcome 3: Infant Respiratory Rate
Time frame: At 0, 30, and 60 minutes.
Secondary Outcome 4: Infant Oxygen Saturation
Time frame: At 0, 30, and 60 minutes.
Secondary Outcome 5: Infant Blood Pressure
Time frame: At 0, 30, and 60 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 31397094Yasova Barbeau D, Krueger C, Huene M, Copenhaver N, Bennett J, Weaver M, Weiss MD. Heart rate variability and inflammatory markers in neonates with hypoxic-ischemic encephalopathy. Physiol Rep. 2019 Aug;7(15):e14110. doi: 10.14814/phy2.14110.
- Results publication: PubMed 19692803van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
- Results publication: PubMed 34713833Huang Q, Lai X, Liao J, Tan Y. Effect of non-pharmacological interventions on sleep in preterm infants in the neonatal intensive care unit: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2021 Oct 29;100(43):e27587. doi: 10.1097/MD.0000000000027587.
- Results publication: PubMed 31366597Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378.
- Results publication: PubMed 35634367Caba-Flores MD, Ramos-Ligonio A, Camacho-Morales A, Martinez-Valenzuela C, Viveros-Contreras R, Caba M. Breast Milk and the Importance of Chrononutrition. Front Nutr. 2022 May 12;9:867507. doi: 10.3389/fnut.2022.867507. eCollection 2022.
- Derived from this study: PubMed 42429091Bolacali ET, Erturk F, Ozcan B, Kucukoglu S. Effect of Automatic Infant Swing on Sleep-Wake Cycles and Comfort: A Randomized Controlled Study Protocol. Nurs Crit Care. 2026 Jul;31(4):e70570. doi: 10.1111/nicc.70570.
- Individual participant dataSharing planned: No
Related trials for Sleep Quality
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Not yet recruitingPhase 2
Lemborexant on Perioperative Sleep Quality in Patients With Brain Tumor Undergoing Surgery
Brain Neoplasms, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 2
Lemborexant on Perioperative Sleep Quality in Patients With Parkinson's Disease Undergoing Deep Brain Stimulation
Parkinson Disease (PD), Sleep Initiation and Maintenance Disorders
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.
Questions about this trial
What is this clinical trial studying?
A study testing Care: Automatic Baby Swing in people with Sleep Quality, run by Kirsehir Ahi Evran Universitesi.
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 7 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: opening soon, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edanur Tar Bolacalı, PhD (+905332668360 ext. +908504412483, edanurtar.1107@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1: COMFORTneo Total Score (time frame: At 0, 30, and 60 minutes.). 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 NCT07284303, which also lists 6 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 22 Dec 2025.