The Gestational Age of the Newborn is Between 28-37 WeeksNCT06964204
The Effect of Kangaroo Care and Lullaby on Mother-Baby Physiological Parameters and Mother's State Anxiety Level
A study testing Kangaroo Care and Kangaroo Care+lullabies in people with The Gestational Age of the Newborn is Between 28-37 Weeks and Stable Health Status of the Newborn, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effect of kangaroo care and lullaby on mother-baby physiologic parameters and mother's state anxiety level in premature newborns. Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- The Gestational Age of the Newborn is Between 28-37 Weeks, Stable Health Status of the Newborn, Mothers' Willingness to Participate in the Study
- What is being tested?
- Kangaroo Care and Kangaroo Care+lullabies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Sep 2025
- 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 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The gestational age of the newborn is between 28-37 weeks,
- Stable health status of the newborn,
- Mothers' willingness to participate in the study.
Who cannot join
- The gestational week of the newborn is below 28 weeks and above 37 weeks
- Unstable health status of the newborn,
- Hospitalization for at least 3 days,
- Parents were not willing to participate in the study.
- Sudden need for resuscitation
- Sudden deterioration of the stabilization of health status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirsehir Ahi Evran University
Kırşehir, Kırşehir, 40100
About this study
Official title: The Effect of Kangaroo Care and Lullaby on Mother-Baby Physiological Parameters and Mother's State Anxiety Level in Premature Newborns: A Randomized Controlled Study
This study was planned to investigate the effect of kangaroo care and lullaby on mother-baby physiologic parameters and mother's state anxiety level in premature newborns.
Read the detailed description
Due to health problems, premature infants are subjected to many painful and uncomfortable interventions such as intubation and respiratory support, umbilical catheter, intravenous interventions, nasogastric catheter, sometimes gastrostomy, peritoneal dialysis, eye examinations and operations. The premature newborn may therefore be deprived of compassionate care that will provide comfort, such as sucking, cuddling, touching and eye contact, which are basic needs. The mother-infant relationship may be negatively affected because premature babies are different from what is imagined and have some health problems and are transferred to the intensive care unit. The birth of a premature baby, which is a crisis for the whole family, can cause intense anxiety and fear that the mother will lose her baby. The mother may avoid touching her baby for fear of harming her baby, and participating in the care of her baby can be very difficult and anxiety-provoking. Nurses working in the neonatal service and neonatal intensive care unit play a major role in ensuring mother-infant interaction in premature babies. It should enable the mother to share the same room (rooming-in), skin-to-skin contact (kangaroo care), eye-to-eye contact, hugging her baby, participating in the care of her baby and maintaining breastfeeding, which will increase the intimacy between mother and baby. Kangaroo care is a method in which newborns are placed on their mothers' chests, facing the mother, and skin-to-skin contact between mother and baby is ensured in order to ensure the early discharge of the baby from the hospital and to ensure that the baby starts to benefit from breast milk as soon as possible. Kangaroo care should be initiated as early as possible in the delivery room or neonatal intensive care unit to ensure thermal regulation, physiological stability, appropriate stimulation and to increase the rate of attachment and breastfeeding. It is known that the fetus recognizes the mother's voice from the 32nd week of gestation and in the postnatal period and responds with parameters such as increased pulse rate. It is argued that lullaby recital in neonatal intensive care has a relaxing effect on the newborn by masking environmental stressors and negative sounds. During kangaroo care, the baby's ear rests directly against the mother's breast, skin-to-skin contact and sounds are transferred to the baby through tissue and air, and the mother's voice is compared to the fetal auditory environment that the baby hears in the uterus, and it is thought that the positive effects on the mother and baby should be examined. This study was planned to examine the effect of kangaroo care and lullaby on the physiologic parameters of the mother and infant and the mother's state anxiety level in premature newborns. Thus, it is aimed to provide physiological stability in the infant and to increase mother-infant bonding by determining the effect of kangaroo care and lullaby, which are safe, inexpensive and easily applicable methods, on the vital signs of the mother and infant and the anxiety level of the mother.
- Conditions
- The Gestational Age of the Newborn is Between 28-37 Weeks, Stable Health Status of the Newborn, Mothers' Willingness to Participate in the Study
- Being tested
- Kangaroo Care, Kangaroo Care+lullabies
- Keywords
- Infant, Premature, Kangaroo-Mother Care Method, Lullabies, Physiological Parameters, Anxiety
- Medical subject headings
- Premature Birth, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareBehavioural
Kangaroo care practice will be carried out in 3 stages: "preparation, implementation and recording stage". Vital signs of the baby such as body temperature, heart rate, respiratory rate will be evaluated and necessary materials such as hats and covers will be prepared. In the implementation phase; the general condition of the baby will be checked, clothing and position will be adjusted, and then the baby will be transferred to the mother. After the baby is placed, his/her back will be covered with a blanket and the mother will be asked to support the baby's back with one hand and the hips with the other. When 60 minutes are completed, kangaroo care will be terminated. After the baby is placed, vital signs and general condition will be evaluated and all nursing observations will be recorded. For the babies in the other group, their mothers will sing lullabies along with kangaroo care and inclusion in the groups will be done by randomization.
Kangaroo Care+lullabiesBehavioural
For the babies in the other group, their mothers will sing lullabies along with kangaroo care and inclusion in the groups will be done by randomization.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Care | Experimental | Kangaroo care will be applied to the babies in the 1st group and inclusion in the groups will be done by randomization. Receives: Behavioral: Kangaroo Care |
| Kangaroo Care + Lullaby | Experimental | In addition to kangaroo care, mothers will sing a lullaby to the babies in the 2nd group and inclusion in the groups will be done by randomization. Receives: Behavioral: Kangaroo Care+lullabies |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Mother and Newborn Introductory Information Form
The form prepared by the researcher in line with the literature (Arnon et al., 2014) consists of a total of 22 questions about the mother and the infant. The questions questioning the characteristics of the mother in the form are "age, educational status, occupation, family type, presence of social security, economic status, disease status, number of pregnancies, whether the last pregnancy was planned, and when she breastfed her baby for the first time after birth". The questions about the infant consisted of "gender, gestational age, postnatal age, mode of delivery, 1st and 5th minute APGAR score, birth and weight, height, head circumference, hospitalization diagnosis and duration, and infant's diet". The form was sent to 5 academicians specialized in Pediatric Nursing and their expert opinions were obtained, and the information form was finalized in line with their suggestions.
Measured: First measurement - Before starting the study
Secondary outcomes (1)
2. Mother Infant Physiologic Parameters Monitoring Form
The chart was created by the researcher to monitor the physiologic parameters of the newborn according to the type of intervention (kangaroo care - lullaby with kangaroo care) (Yasova Barbeau et al., 2019). Measurements of "body temperature (°C), peak heart rate (min), respiratory rate (min), oxygen saturation (mmHg), blood pressure (mmHg)" of infants and mothers before and after the intervention will be recorded in this chart. The chart was sent to 5 academicians who are experts in Pediatric Nursing and their expert opinions were taken and the chart was finalized by making the necessary changes in line with their suggestions.
Measured: Before and after the intervention for 3 days after starting the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start15 May 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for The Gestational Age of the Newborn is Between 28-37 WeeksStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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 sample of the study will be selected by "random sampling" method from mothers and their babies who are diagnosed and treated in the NICU of Osmaniye State Hospital and who meet the criteria for acceptance into the study. The sample size of the study was calculated as a total of 57 newborns in the G\*Power 3.1.9.2. program with reference to a similar study in the literature (Arnon, 2014), which is parallel to our study. In the study, in order to reduce selection bias and control variables that may have an effect on the outcome parameters, the groups will be named as A and B and newborns will be randomly assigned to these groups. A: kangaroo care and B: kangaroo care+nurture or B: kangaroo care and A: kangaroo care+nurture will be determined by lottery. Before the study, mothers will be informed about both groups during the informed consent process and it will not be specified which group the newborns will be in.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
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
- NCT06964204
- Sponsor's protocol ID
- SU-2025-041
- Status last verified
- Sep 2025
- First submitted
- 1 May 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will be shared upon reasonable request from qualified researchers. Requests will be evaluated by the study investigators, and data will be shared in compliance with ethical and institutional regulations.
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 31397094Öner N, Le Compte A. Durumluk Sürekli Kaygı Envanteri El Kitabı, İstanbul, Boğaziçi Üniversitesi Yayınları, İstanbul, 1983.
Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.
PubMed 36511921Arnon S, Diamant C, Bauer S, Regev R, Sirota G, Litmanovitz I. Maternal singing during kangaroo care led to autonomic stability in preterm infants and reduced maternal anxiety. Acta Paediatr. 2014 Oct;103(10):1039-44. doi: 10.1111/apa.12744. Epub 2014 Aug 11.
PubMed 25039678Tar Bolacali E, Kucukoglu S, Aksu E. Impact of Kangaroo Care and Lullaby Intervention on Maternal Anxiety and Physiological Stability of Mothers and Preterm Infants: A Randomized Controlled Study. Adv Neonatal Care. 2026 Jun 18. doi: 10.1097/ANC.0000000000001396. Online ahead of print.
PubMed 42307478
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Care and Lullaby on Mother-Baby Physiological Parameters and Mother's State Anxiety Level in Premature Newborns: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06964204
- Acronym / sponsor ID
- SU-2025-041
- Conditions
- The Gestational Age of the Newborn is Between 28-37 Weeks, Stable Health Status of the Newborn, Mothers' Willingness to Participate in the Study
- Keywords
- Infant, Premature, Kangaroo-Mother Care Method, Lullabies, Physiological Parameters, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 9 May 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 investigate the effect of kangaroo care and lullaby on mother-baby physiologic parameters and mother's state anxiety level in premature newborns.
Detailed description
Due to health problems, premature infants are subjected to many painful and uncomfortable interventions such as intubation and respiratory support, umbilical catheter, intravenous interventions, nasogastric catheter, sometimes gastrostomy, peritoneal dialysis, eye examinations and operations. The premature newborn may therefore be deprived of compassionate care that will provide comfort, such as sucking, cuddling, touching and eye contact, which are basic needs. The mother-infant relationship may be negatively affected because premature babies are different from what is imagined and have some health problems and are transferred to the intensive care unit. The birth of a premature baby, which is a crisis for the whole family, can cause intense anxiety and fear that the mother will lose her baby. The mother may avoid touching her baby for fear of harming her baby, and participating in the care of her baby can be very difficult and anxiety-provoking. Nurses working in the neonatal service and neonatal intensive care unit play a major role in ensuring mother-infant interaction in premature babies. It should enable the mother to share the same room (rooming-in), skin-to-skin contact (kangaroo care), eye-to-eye contact, hugging her baby, participating in the care of her baby and maintaining breastfeeding, which will increase the intimacy between mother and baby. Kangaroo care is a method in which newborns are placed on their mothers' chests, facing the mother, and skin-to-skin contact between mother and baby is ensured in order to ensure the early discharge of the baby from the hospital and to ensure that the baby starts to benefit from breast milk as soon as possible. Kangaroo care should be initiated as early as possible in the delivery room or neonatal intensive care unit to ensure thermal regulation, physiological stability, appropriate stimulation and to increase the rate of attachment and breastfeeding. It is known that the fetus recognizes the mother's voice from the 32nd week of gestation and in the postnatal period and responds with parameters such as increased pulse rate. It is argued that lullaby recital in neonatal intensive care has a relaxing effect on the newborn by masking environmental stressors and negative sounds. During kangaroo care, the baby's ear rests directly against the mother's breast, skin-to-skin contact and sounds are transferred to the baby through tissue and air, and the mother's voice is compared to the fetal auditory environment that the baby hears in the uterus, and it is thought that the positive effects on the mother and baby should be examined. This study was planned to examine the effect of kangaroo care and lullaby on the physiologic parameters of the mother and infant and the mother's state anxiety level in premature newborns. Thus, it is aimed to provide physiological stability in the infant and to increase mother-infant bonding by determining the effect of kangaroo care and lullaby, which are safe, inexpensive and easily applicable methods, on the vital signs of the mother and infant and the anxiety level of the mother.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The sample of the study will be selected by "random sampling" method from mothers and their babies who are diagnosed and treated in the NICU of Osmaniye State Hospital and who meet the criteria for acceptance into the study. The sample size of the study was calculated as a total of 57 newborns in the G*Power 3.1.9.2. program with reference to a similar study in the literature (Arnon, 2014), which is parallel to our study. In the study, in order to reduce selection bias and control variables that may have an effect on the outcome parameters, the groups will be named as A and B and newborns will be randomly assigned to these groups. A: kangaroo care and B: kangaroo care+nurture or B: kangaroo care and A: kangaroo care+nurture will be determined by lottery. Before the study, mothers will be informed about both groups during the informed consent process and it will not be specified which group the newborns will be in.
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Care | Experimental | Behavioral: Kangaroo CareKangaroo care will be applied to the babies in the 1st group and inclusion in the groups will be done by randomization. |
| Kangaroo Care + Lullaby | Experimental | Behavioral: Kangaroo Care+lullabiesIn addition to kangaroo care, mothers will sing a lullaby to the babies in the 2nd group and inclusion in the groups will be done by randomization. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The gestational age of the newborn is between 28-37 weeks,
- Stable health status of the newborn,
- Mothers' willingness to participate in the study.
Key exclusion criteria (6 listed)
- The gestational week of the newborn is below 28 weeks and above 37 weeks
- Unstable health status of the newborn,
- Hospitalization for at least 3 days,
- Parents were not willing to participate in the study.
- Sudden need for resuscitation
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 |
|---|---|---|
| Kangaroo CareKangaroo care practice will be carried out in 3 stages: "preparation, implementation and recording stage". Vital signs of the baby such as body temperature, heart rate, respiratory rate will be evaluated and necessary materials such as hats and covers will be prepared. In the implementation phase; the general condition of the baby will be checked, clothing and position will be adjusted, and then the baby will be transferred to the mother. After the baby is placed, his/her back will be covered with a blanket and the mother will be asked to support the baby's back with one hand and the hips with the other. When 60 minutes are completed, kangaroo care will be terminated. After the baby is placed, vital signs and general condition will be evaluated and all nursing observations will be recorded. For the babies in the other group, their mothers will sing lullabies along with kangaroo care and inclusion in the groups will be done by randomization. | Behavioural | Kangaroo Care |
| Kangaroo Care+lullabiesFor the babies in the other group, their mothers will sing lullabies along with kangaroo care and inclusion in the groups will be done by randomization. | Behavioural | Kangaroo Care + Lullaby |
Primary outcome
1. Mother and Newborn Introductory Information Form
Time frame: First measurement - Before starting the study
The form prepared by the researcher in line with the literature (Arnon et al., 2014) consists of a total of 22 questions about the mother and the infant. The questions questioning the characteristics of the mother in the form are "age, educational status, occupation, family type, presence of social security, economic status, disease status, number of pregnancies, whether the last pregnancy was planned, and when she breastfed her baby for the first time after birth". The questions about the infant consisted of "gender, gestational age, postnatal age, mode of delivery, 1st and 5th minute APGAR score, birth and weight, height, head circumference, hospitalization diagnosis and duration, and infant's diet". The form was sent to 5 academicians specialized in Pediatric Nursing and their expert opinions were obtained, and the information form was finalized in line with their suggestions.
1 secondary outcome
2. Mother Infant Physiologic Parameters Monitoring Form
Time frame: Before and after the intervention for 3 days after starting the study
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 4 Nov 2026.
- 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 publicationÖner N, Le Compte A. Durumluk Sürekli Kaygı Envanteri El Kitabı, İstanbul, Boğaziçi Üniversitesi Yayınları, İstanbul, 1983.
- Results publication: PubMed 36511921Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension. JAMA. 2022 Dec 13;328(22):2252-2264. doi: 10.1001/jama.2022.21022.
- Results publication: PubMed 25039678Arnon S, Diamant C, Bauer S, Regev R, Sirota G, Litmanovitz I. Maternal singing during kangaroo care led to autonomic stability in preterm infants and reduced maternal anxiety. Acta Paediatr. 2014 Oct;103(10):1039-44. doi: 10.1111/apa.12744. Epub 2014 Aug 11.
- Derived from this study: PubMed 42307478Tar Bolacali E, Kucukoglu S, Aksu E. Impact of Kangaroo Care and Lullaby Intervention on Maternal Anxiety and Physiological Stability of Mothers and Preterm Infants: A Randomized Controlled Study. Adv Neonatal Care. 2026 Jun 18. doi: 10.1097/ANC.0000000000001396. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will be shared upon reasonable request from qualified researchers. Requests will be evaluated by the study investigators, and data will be shared in compliance with ethical and institutional regulations.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care and Kangaroo Care+lullabies in people with The Gestational Age of the Newborn is Between 28-37 Weeks and Stable Health Status of the Newborn, run by Kirsehir Ahi Evran Universitesi 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 3 inclusion and 6 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 4 Nov 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?
1. Mother and Newborn Introductory Information Form (time frame: First measurement - Before starting the study). 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 NCT06964204, which also lists 5 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 4 Nov 2026.