Congenital Heart SurgeryNCT07319858
The Effect of Using Multifunctional Baby Carrier With Heart Surgery
A study testing Multifunctional Baby Carrier in people with Congenital Heart Surgery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The study aims to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, crying, and sleep status in infants aged 0-3 months who have undergone congenital heart surgery. Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Congenital Heart Surgery
- What is being tested?
- Multifunctional Baby Carrier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Aug 2028
- 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 1 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies born at 38 weeks or later
- Babies aged 0 to 3 months after birth
- No illness other than congenital heart disease
- Who has undergone surgery for the first time due to congenital heart disease
- Whose clinical condition is stable (PSOFA score below 8 points)
- Infants with stable thermoregulation
Who cannot join
- Babies born before 38 weeks of pregnancy
- Babies older than 3 months
- The presence of other chromosomal or neurological disorders and syndromes in the infant
- Those who have undergone two or more surgeries due to congenital heart disease
- pSOFA score above 8 points
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Health Sciences University Dr. Siyami Ersek Chest, Heart, and Vascular Surgery Education and Research Hospital
Istanbul, Üsküdar, 34668
Aynur Baykal, Phd Student, aynur.baykal10@ogr.iuc.edu.tr
Birsen Mutlu, Assc prof, +90 532 682 68 62, bdonmez@iuc.edu.tr
About this study
Official title: The Effect of Using Multifunctional Baby Carrier on Physiological Parameters, Pain and Sleep Status in Babies With Heart Surgery
The study aims to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, crying, and sleep status in infants aged 0-3 months who have undergone congenital heart surgery. It is planned to be conducted in a randomized controlled crossover design. Following congenital heart surgery, the use of sedative interventions in the high-stress environment of the intensive care unit has a significant effect on preserving the energy reserves necessary for the infant's growth and development. Using a sensitive and soothing mobile crib to assist in the postoperative care of infants who have undergone congenital heart surgery is a potential opportunity for the infant, nurse, and parent. The combined application of swaddling, sound, and movement reduces the baby's fussiness and has a calming effect on their physiological activation.
Infants who underwent heart surgery between 0-3 months and were followed up in a multi-purpose baby carrier (swaddling, white noise, and rocking) compared to infants in the follow-up experimental group, compared to infants in the control group who were only swaddled;
Hypothesis 1: The heart rate is lower. Hypothesis 2: Blood pressure is lower. Hypothesis 3: Oxygen saturation levels are higher. Hypothesis 4: Sleep durations are longer. Hypothesis 5: Pain scores are lower.
Read the detailed description
This thesis study was designed to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, pain, crying, and sleep status in infants aged 0-3 months who underwent congenital heart surgery.
The sample size for the study, which is a 2x2 crossover design, was calculated using power analysis a large effect size and 80% power, resulting in a sample size of 52. Infants will be assigned to groups using simple randomization.
The dependent variables of the study are the infant's heart rate, blood pressure, oxygen saturation, sleep status, pain scale score, and crying duration. The independent variables are: the baby's gender, the baby's age, the postoperative day, the time spent at home with the parent, swaddling, white noise, and rocking.
Research groups: 1. Swaddling group (control), 2. Swaddling combined with rocking and white noise feature in a multifunctional primary cradle group.
In the crossover design, two groups were defined: Group A and Group B, where interventions were applied in different orders.
The data collection tools used in the study were the Infant Information Form, Infant Intervention Monitoring Form, Neonatal Pain, Agitation, and Sedation Scale (N PASS), Pediatric Sequential Organ Failure Assessment Score (pSOFA), Informed Consent Form-Parent Form, monitor , actigraph, stopwatch, decibel meter, swaddling cloth, and multi-functional baby carrier crib will be used as data collection tools in the study. Research data will be analyzed using the Statistical Package for Social Sciences (SPSS) program.
The safety of patients' vital sign data will be ensured through graphs. Pain assessment using the N-PASS scale will be evaluated by the same two observers, and inter-observer agreement will be examined.
- Conditions
- Congenital Heart Surgery
- Being tested
- Multifunctional Baby Carrier
- Keywords
- nursing, pain, sleep, congenital heart defect, surgery
- Medical subject headings
- Pain, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifunctional Baby CarrierOther
The study will be conducted using a randomized controlled crossover design. Infants will be assigned to either group A or group B using a simple randomization method. The infant will be assigned to the control and experimental groups according to the order of initiation within the group to which the infant belongs. Since the study is cross-over in design, infants in both groups (Group A and Group B) will be included in both the experimental group and the control group. Each baby will be monitored for a total of 6 hours.
Group A (26 babies):
- Monitoring in a multifunctional main cradle during the first 3 hours (experiment)
- Monitoring in an open incubator wrapped for the second 3 hours (control)
Group B (26 babies):
- Monitoring in an open incubator wrapped for the second 3 hours (control)
- Monitoring in a multifunctional main cradle during the first 3 hours (experiment)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A (26 babies) :
1. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment)
2. Monitoring in an open incubator for the next 3 hours (control) Receives: Other: Multifunctional Baby Carrier |
| Group B | Active comparator | Group B (26 babies) :
1. Monitoring in an open incubator for the next 3 hours (control)
2. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment) Receives: Other: Multifunctional Baby Carrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Pain, Agitation and Sedation Scale (N PASS Scale)
Term and preterm newborns are used for the purpose of evaluating postoperative pain/agitation and sedation. The total pain score ranges from 0 to +11. A high score indicates significant pain.
Measured: 6 hours
Sleep-Wake Status Measurement Device (Actigraphy)
It is used to monitor babies' sleep-wake cycles.
Measured: 6 hours
Secondary outcomes (1)
Pediatric Sequential Organ Failure Assessment Score (pSOFA)
It is used to measure the severity of the disease and determine mortality. The lowest score is 0 and the highest score is 28 points. It is stated that mortality increases as the score increases. The Pediatric Sequential Organ Failure Assessment Score cutoff point distinguishing mortality is specified as 8 points. For this reason, infants with a pSOFA score below 8 points will be included in our study.
Measured: 6 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 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will be conducted using a randomized controlled crossover design. Research groups: 1. Swaddling group (control), 2. Swaddling combined with rocking and white noise feature in a multifunctional primary cradle group. In the crossover design, two groups were defined: Group A and Group B, where interventions were applied in different orders. Infants will be assigned to either group A or group B using a simple randomization method. The infant will be assigned to the control and experimental groups according to the order of initiation within the group to which the infant belongs.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Baykal, Istanbul University - Cerrahpasa
- Investigators
- Birsen Mutlu, Assc prof, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319858
- Sponsor's protocol ID
- IUC-PHD-NURS-2025-01
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The consent forms stated that the confidentiality of the information would be protected and that it would be used only for the evaluation of the data in this study without identifying information.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Multifunctional Baby Carrier on Physiological Parameters, Pain and Sleep Status in Babies With Heart Surgery
- ClinicalTrials.gov ID
- NCT07319858
- Acronym / sponsor ID
- IUC-PHD-NURS-2025-01
- Conditions
- Congenital Heart Surgery
- Keywords
- nursing, pain, sleep, congenital heart defect, surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 6 Jan 2026 (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 study aims to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, crying, and sleep status in infants aged 0-3 months who have undergone congenital heart surgery. It is planned to be conducted in a randomized controlled crossover design. Following congenital heart surgery, the use of sedative interventions in the high-stress environment of the intensive care unit has a significant effect on preserving the energy reserves necessary for the infant's growth and development. Using a sensitive and soothing mobile crib to assist in the postoperative care of infants who have undergone congenital heart surgery is a potential opportunity for the infant, nurse, and parent. The combined application of swaddling, sound, and movement reduces the baby's fussiness and has a calming effect on their physiological activation.
Infants who underwent heart surgery between 0-3 months and were followed up in a multi-purpose baby carrier (swaddling, white noise, and rocking) compared to infants in the follow-up experimental group, compared to infants in the control group who were only swaddled;
Hypothesis 1: The heart rate is lower. Hypothesis 2: Blood pressure is lower. Hypothesis 3: Oxygen saturation levels are higher. Hypothesis 4: Sleep durations are longer. Hypothesis 5: Pain scores are lower.
Detailed description
This thesis study was designed to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, pain, crying, and sleep status in infants aged 0-3 months who underwent congenital heart surgery.
The sample size for the study, which is a 2x2 crossover design, was calculated using power analysis a large effect size and 80% power, resulting in a sample size of 52. Infants will be assigned to groups using simple randomization.
The dependent variables of the study are the infant's heart rate, blood pressure, oxygen saturation, sleep status, pain scale score, and crying duration. The independent variables are: the baby's gender, the baby's age, the postoperative day, the time spent at home with the parent, swaddling, white noise, and rocking.
Research groups: 1. Swaddling group (control), 2. Swaddling combined with rocking and white noise feature in a multifunctional primary cradle group.
In the crossover design, two groups were defined: Group A and Group B, where interventions were applied in different orders.
The data collection tools used in the study were the Infant Information Form, Infant Intervention Monitoring Form, Neonatal Pain, Agitation, and Sedation Scale (N PASS), Pediatric Sequential Organ Failure Assessment Score (pSOFA), Informed Consent Form-Parent Form, monitor , actigraph, stopwatch, decibel meter, swaddling cloth, and multi-functional baby carrier crib will be used as data collection tools in the study. Research data will be analyzed using the Statistical Package for Social Sciences (SPSS) program.
The safety of patients' vital sign data will be ensured through graphs. Pain assessment using the N-PASS scale will be evaluated by the same two observers, and inter-observer agreement will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted using a randomized controlled crossover design. Research groups: 1. Swaddling group (control), 2. Swaddling combined with rocking and white noise feature in a multifunctional primary cradle group. In the crossover design, two groups were defined: Group A and Group B, where interventions were applied in different orders. Infants will be assigned to either group A or group B using a simple randomization method. The infant will be assigned to the control and experimental groups according to the order of initiation within the group to which the infant belongs.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Multifunctional Baby CarrierGroup A (26 babies) : 1. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment) 2. Monitoring in an open incubator for the next 3 hours (control) |
| Group B | Active comparator | Other: Multifunctional Baby CarrierGroup B (26 babies) : 1. Monitoring in an open incubator for the next 3 hours (control) 2. Monitoring in a multifunctional baby carrier for the first 3 hours (experiment) |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Babies born at 38 weeks or later
- Babies aged 0 to 3 months after birth
- No illness other than congenital heart disease
- Who has undergone surgery for the first time due to congenital heart disease
- Whose clinical condition is stable (PSOFA score below 8 points)
Key exclusion criteria (5 listed)
- Babies born before 38 weeks of pregnancy
- Babies older than 3 months
- The presence of other chromosomal or neurological disorders and syndromes in the infant
- Those who have undergone two or more surgeries due to congenital heart disease
- pSOFA score above 8 points
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 |
|---|---|---|
| Multifunctional Baby CarrierThe study will be conducted using a randomized controlled crossover design. Infants will be assigned to either group A or group B using a simple randomization method. The infant will be assigned to the control and experimental groups according to the order of initiation within the group to which the infant belongs. Since the study is cross-over in design, infants in both groups (Group A and Group B) will be included in both the experimental group and the control group. Each baby will be monitored for a total of 6 hours. Group A (26 babies): 1. Monitoring in a multifunctional main cradle during the first 3 hours (experiment) 2. Monitoring in an open incubator wrapped for the second 3 hours (control) Group B (26 babies): 1. Monitoring in an open incubator wrapped for the second 3 hours (control) 2. Monitoring in a multifunctional main cradle during the first 3 hours (experiment) | Other | Group A, Group B |
Primary outcome
Newborn Pain, Agitation and Sedation Scale (N PASS Scale)
Time frame: 6 hours
Term and preterm newborns are used for the purpose of evaluating postoperative pain/agitation and sedation. The total pain score ranges from 0 to +11. A high score indicates significant pain.
Sleep-Wake Status Measurement Device (Actigraphy)
Time frame: 6 hours
It is used to monitor babies' sleep-wake cycles.
1 secondary outcome
Pediatric Sequential Organ Failure Assessment Score (pSOFA)
Time frame: 6 hours
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 21 Apr 2026.
- Individual participant dataSharing planned: No. The consent forms stated that the confidentiality of the information would be protected and that it would be used only for the evaluation of the data in this study without identifying information.
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Autus Valve Pivotal Study
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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.
Birsen Mutlu, Assc prof study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifunctional Baby Carrier in people with Congenital Heart Surgery, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 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 21 Apr 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?
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 Aynur Baykal, Phd Student (+90 538 471 39 71, aynur.baykal10@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn Pain, Agitation and Sedation Scale (N PASS Scale) (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.