Procedural PainNCT07761689
The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
A study testing Kangaroo Care and Routine Care in people with Procedural Pain and Neonatal Hyperbilirubinemia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy. Specifically, the research investigates the impact of mother-administered versus nurse-administered kangaroo care on pain levels during mandatory heel-stick blood… Read more about this study
- Who is it for?
- Ages 2 to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Neonatal Hyperbilirubinemia
- What is being tested?
- Kangaroo Care and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 31 Dec 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 2 to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Voluntary participation of the mother
- Gestational age of 38 weeks or more
- Diagnosis of physiological hyperbilirubinemia only
- Serum bilirubin level within the moderate-high range (13-18 mg/dL) according to the Turkish Neonatal Society Guideline for the Management, Follow-up, and Treatment of Neonatal Jaundice (2022 update)
- Postnatal age between 2 and 7 days
- Absence of any condition preventing the infant from feeding
- Absence of any maternal health condition that would preclude the application of kangaroo care
- Ability of the mother to speak Turkish and to understand the information provided about the study
Who cannot join
- Gestational age less than 34 weeks or 38 weeks and above
- Diagnosis of sepsis or any other systemic infection
- Presence of congenital anomalies
- Diagnosis of pathological jaundice
- Use of antibiotic therapy
- Serum bilirubin level greater than 18 mg/dL
- Postnatal age greater than 7 days
- Mother's refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Çağrı ÇÖVENER ÖZÇELİK, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Istanbul
Ebru UYGUR, MSc(student), 05336822564, ebruygurr@gmail.com
Çağrı ÇÖVENER ÖZÇELİK, PhD, ccovener@gmail.com
About this study
Official title: The Effect of Two Different Kangaroo Care Interventions on Pain Level During Heel Prick Procedure in Neonates Receiving Phototherapy: A Randomized Controlled Trial
This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy. Specifically, the research investigates the impact of mother-administered versus nurse-administered kangaroo care on pain levels during mandatory heel-stick blood sampling. The study seeks to determine which provider model is more effective in reducing procedural pain for these vulnerable newborns, thereby optimizing comfort and care protocols during phototherapy treatment.
Read the detailed description
Kangaroo care is a highly effective, low-cost, and feasible method for reducing crying duration and alleviating pain in newborns. This method is most commonly provided by the mother. However, the World Health Organization states that when the mother is unable to participate, kangaroo care may also be provided by other family members, such as the father or grandmother, a close friend, or a trained healthcare professional. Particularly in neonatal intensive care unit settings, it is not always possible for mothers to remain continuously with their infants outside visiting hours. During periods when the mother is unavailable, nurses may be considered as alternative providers of kangaroo care for pain management; however, due to the limited scientific evidence on this topic, the effectiveness of nurse-provided kangaroo care remains unclear. By addressing this gap in the literature, the present study aims to examine the effect of nurse-provided kangaroo care on neonatal pain levels and to contribute to the field of neonatology as an atraumatic care practice.
Newborns participating in the study will be randomly assigned using a simple randomization method to three groups: experimental group 1 (mother-provided kangaroo care), experimental group 2 (nurse-provided kangaroo care), and the control group. Newborns in experimental group 1 will receive kangaroo care by being placed, wearing only a diaper, in direct skin-to-skin contact with their mother's bare chest. The intervention will be initiated 15 minutes before the heel-prick blood sampling procedure, maintained throughout the procedure, and continued for an additional 15 minutes after the procedure. To eliminate the potential effects of hunger or satiety on neonatal pain responses, all newborns will be fed at least 30 minutes prior to the procedure.
Physiological parameters, including oxygen saturation (SpO₂), heart rate, respiratory rate, and body temperature, will be measured and recorded using a monitor before the procedure (0 minute), during the procedure, and at 2 and 10 minutes after the procedure. Phototherapy will not be interrupted during the procedure. Heel-prick blood sampling will be performed by a neonatal intensive care unit nurse after cleansing the puncture site with 70% alcohol and allowing it to dry, using an automatic lancet routinely employed in the unit.
Pain levels and crying duration will be assessed using video recordings obtained before, during, and after the procedure (at 2 and 10 minutes). These recordings will be evaluated after completion of the procedure by both the researcher and an independent observer (a neonatal intensive care unit nurse) using the Neonatal Infant Pain Scale (NIPS), and the results will be recorded on the observation form. Newborns in experimental group 2 will receive nurse-provided kangaroo care, and all intervention, measurement, and evaluation procedures will be conducted in the same manner as in experimental group 1. Newborns in the control group will undergo heel-prick blood sampling in a standard position within an incubator, in accordance with routine hospital practices, without the application of kangaroo care; all measurement and evaluation procedures will be conducted in the same manner as in experimental groups 1 and 2.
If the results of the study demonstrate that mother-provided kangaroo care is more effective, recommendations may be developed to strengthen family-centered care practices. Alternatively, if nurse-provided kangaroo care is shown to produce comparable effects, nurses may be encouraged to incorporate this method into neonatal care protocols as a standard practice in situations where the mother is unavailable, deceased, or unable to provide kangaroo care. Through this study, non-pharmacological pain management strategies may be updated, thereby contributing scientifically to neonatal care through nurses' implementation of atraumatic care practices. In addition, the findings of this study may provide a foundation for future research.
- Conditions
- Procedural Pain, Neonatal Hyperbilirubinemia
- Being tested
- Kangaroo Care, Routine Care
- Keywords
- Phototherapy, Procedural pain, Kangaroo Care
- Medical subject headings
- Pain, Procedural, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareBehavioural
In this study, kangaroo care is applied as the intervention. Kangaroo care is defined as placing the newborn, wearing only a diaper, in a prone and upright position on the bare chest of the mother (or caregiver), with the infant's back covered with a blanket to prevent heat loss. The intervention is applied during the heel-prick blood sampling procedure in newborns receiving phototherapy, beginning a specified period before the procedure and continuing throughout the procedure. The duration of kangaroo care and the application conditions are standardized for all participants, and no additional analgesic or pharmacological interventions are administered during the intervention.
Routine CareBehavioural
Vital signs will be monitored before, during, and after the procedure (at 0, 2, and 10 minutes). The procedure will be video-recorded, and pain level and crying duration will be assessed using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Mother Kangaroo Care | Experimental | Infants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the mother's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher after reviewing the video recordings. Receives: Behavioral: Kangaroo Care |
| Nurse Kangaroo Care | Experimental | Infants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the researcher's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher. Receives: Behavioral: Kangaroo Care |
| Standart Care (Control) | Active comparator | Infants in this group will undergo the heel-stick procedure in a standard position inside the incubator in accordance with hospital routine, and kangaroo care will not be applied. Vital signs will be monitored before, during, and after the procedure (at 0, 2, and 10 minutes). The procedure will be video-recorded, and pain level and crying duration will be assessed using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher. Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearth rate
hearth rate of the infant in 1 minutes
Measured: 30 minutes
respiratory rate
respiratory rate of the infant in 1 minutes
Measured: 30 minutes
O2 saturation
O2 saturation of the infant
Measured: 30 minutes
body temperature
body temperature of the infant
Measured: 30 minutes
duration of crying
duration of crying of the infant
Measured: 30 minutes
Neonatal Infant Pain Scale
The total score on the NIPS pain scale ranges from 0 to 7. Scores higher than 3 indicate the presence of pain.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment design with three groups: maternal kangaroo care, nurse-led kangaroo care, and standard care (control). Neonates are assigned to one group only, and the assigned intervention is applied during the heel prick blood sampling procedure. Pain levels are compared across groups.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Uygur, Marmara University
- Investigators
- Ebru UYGUR, MSc(student), Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761689
- Sponsor's protocol ID
- E-96317027-514.10-275153008
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.
PubMed 14609899Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
PubMed 8413140
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Kangaroo Care Interventions on Pain Level During Heel Prick Procedure in Neonates Receiving Phototherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07761689
- Acronym / sponsor ID
- E-96317027-514.10-275153008
- Conditions
- Procedural Pain, Neonatal Hyperbilirubinemia
- Keywords
- Phototherapy, Procedural pain, Kangaroo Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Aug 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.
This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy. Specifically, the research investigates the impact of mother-administered versus nurse-administered kangaroo care on pain levels during mandatory heel-stick blood sampling. The study seeks to determine which provider model is more effective in reducing procedural pain for these vulnerable newborns, thereby optimizing comfort and care protocols during phototherapy treatment.
Detailed description
Kangaroo care is a highly effective, low-cost, and feasible method for reducing crying duration and alleviating pain in newborns. This method is most commonly provided by the mother. However, the World Health Organization states that when the mother is unable to participate, kangaroo care may also be provided by other family members, such as the father or grandmother, a close friend, or a trained healthcare professional. Particularly in neonatal intensive care unit settings, it is not always possible for mothers to remain continuously with their infants outside visiting hours. During periods when the mother is unavailable, nurses may be considered as alternative providers of kangaroo care for pain management; however, due to the limited scientific evidence on this topic, the effectiveness of nurse-provided kangaroo care remains unclear. By addressing this gap in the literature, the present study aims to examine the effect of nurse-provided kangaroo care on neonatal pain levels and to contribute to the field of neonatology as an atraumatic care practice.
Newborns participating in the study will be randomly assigned using a simple randomization method to three groups: experimental group 1 (mother-provided kangaroo care), experimental group 2 (nurse-provided kangaroo care), and the control group. Newborns in experimental group 1 will receive kangaroo care by being placed, wearing only a diaper, in direct skin-to-skin contact with their mother's bare chest. The intervention will be initiated 15 minutes before the heel-prick blood sampling procedure, maintained throughout the procedure, and continued for an additional 15 minutes after the procedure. To eliminate the potential effects of hunger or satiety on neonatal pain responses, all newborns will be fed at least 30 minutes prior to the procedure.
Physiological parameters, including oxygen saturation (SpO₂), heart rate, respiratory rate, and body temperature, will be measured and recorded using a monitor before the procedure (0 minute), during the procedure, and at 2 and 10 minutes after the procedure. Phototherapy will not be interrupted during the procedure. Heel-prick blood sampling will be performed by a neonatal intensive care unit nurse after cleansing the puncture site with 70% alcohol and allowing it to dry, using an automatic lancet routinely employed in the unit.
Pain levels and crying duration will be assessed using video recordings obtained before, during, and after the procedure (at 2 and 10 minutes). These recordings will be evaluated after completion of the procedure by both the researcher and an independent observer (a neonatal intensive care unit nurse) using the Neonatal Infant Pain Scale (NIPS), and the results will be recorded on the observation form. Newborns in experimental group 2 will receive nurse-provided kangaroo care, and all intervention, measurement, and evaluation procedures will be conducted in the same manner as in experimental group 1. Newborns in the control group will undergo heel-prick blood sampling in a standard position within an incubator, in accordance with routine hospital practices, without the application of kangaroo care; all measurement and evaluation procedures will be conducted in the same manner as in experimental groups 1 and 2.
If the results of the study demonstrate that mother-provided kangaroo care is more effective, recommendations may be developed to strengthen family-centered care practices. Alternatively, if nurse-provided kangaroo care is shown to produce comparable effects, nurses may be encouraged to incorporate this method into neonatal care protocols as a standard practice in situations where the mother is unavailable, deceased, or unable to provide kangaroo care. Through this study, non-pharmacological pain management strategies may be updated, thereby contributing scientifically to neonatal care through nurses' implementation of atraumatic care practices. In addition, the findings of this study may provide a foundation for future research.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study uses a parallel assignment design with three groups: maternal kangaroo care, nurse-led kangaroo care, and standard care (control). Neonates are assigned to one group only, and the assigned intervention is applied during the heel prick blood sampling procedure. Pain levels are compared across groups.
| Arm | Type | Receives |
|---|---|---|
| Mother Kangaroo Care | Experimental | Behavioral: Kangaroo CareInfants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the mother's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher after reviewing the video recordings. |
| Nurse Kangaroo Care | Experimental | Behavioral: Kangaroo CareInfants will be placed in kangaroo care, with their bare bodies positioned in direct skin-to-skin contact with the researcher's bare chest, starting 15 minutes before the procedure, continuing throughout the procedure, and maintained for 15 minutes after the procedure. Vital signs will be monitored before, during, and after the heel-stick procedure (at 0, 2, and 10 minutes), and the procedure will be video-recorded. Pain level and crying duration will be evaluated using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher. |
| Standart Care (Control) | Active comparator | Behavioral: Routine CareInfants in this group will undergo the heel-stick procedure in a standard position inside the incubator in accordance with hospital routine, and kangaroo care will not be applied. Vital signs will be monitored before, during, and after the procedure (at 0, 2, and 10 minutes). The procedure will be video-recorded, and pain level and crying duration will be assessed using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher. |
Who may qualify
- Ages
- 2 to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Voluntary participation of the mother
- Gestational age of 38 weeks or more
- Diagnosis of physiological hyperbilirubinemia only
- Serum bilirubin level within the moderate-high range (13-18 mg/dL) according to the Turkish Neonatal Society Guideline for the Management, Follow-up, and Treatment of Neonatal Jaundice (2022 update)
- Postnatal age between 2 and 7 days
Key exclusion criteria (8 listed)
- Gestational age less than 34 weeks or 38 weeks and above
- Diagnosis of sepsis or any other systemic infection
- Presence of congenital anomalies
- Diagnosis of pathological jaundice
- Use of antibiotic therapy
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 CareIn this study, kangaroo care is applied as the intervention. Kangaroo care is defined as placing the newborn, wearing only a diaper, in a prone and upright position on the bare chest of the mother (or caregiver), with the infant's back covered with a blanket to prevent heat loss. The intervention is applied during the heel-prick blood sampling procedure in newborns receiving phototherapy, beginning a specified period before the procedure and continuing throughout the procedure. The duration of kangaroo care and the application conditions are standardized for all participants, and no additional analgesic or pharmacological interventions are administered during the intervention. | Behavioural | Mother Kangaroo Care, Nurse Kangaroo Care |
| Routine CareVital signs will be monitored before, during, and after the procedure (at 0, 2, and 10 minutes). The procedure will be video-recorded, and pain level and crying duration will be assessed using the Neonatal Infant Pain Scale (NIPS) by an independent observer and the researcher. | Behavioural | Standart Care (Control) |
Primary outcome
Hearth rate
Time frame: 30 minutes
hearth rate of the infant in 1 minutes
respiratory rate
Time frame: 30 minutes
respiratory rate of the infant in 1 minutes
O2 saturation
Time frame: 30 minutes
O2 saturation of the infant
body temperature
Time frame: 30 minutes
body temperature of the infant
duration of crying
Time frame: 30 minutes
duration of crying of the infant
Neonatal Infant Pain Scale
Time frame: 30 minutes
The total score on the NIPS pain scale ranges from 0 to 7. Scores higher than 3 indicate the presence of pain.
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 12 Aug 2026.
- Background: PubMed 14609899Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.
- Results publication: PubMed 8413140Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
- 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.
Çağrı ÇÖVENER ÖZÇELİK, PhD contact
Ebru UYGUR, MSc(student) principal investigator
Marmara 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 Kangaroo Care and Routine Care in people with Procedural Pain and Neonatal Hyperbilirubinemia, run by Marmara 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 12 Aug 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 Ebru UYGUR, MSc (05336822564, ebruygurr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearth rate (time frame: 30 minutes). The study lists 6 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 NCT07761689, which also lists 2 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 12 Aug 2026.