The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy

NCT07761689 | Recruiting

• 1 other identifier: E-96317027-514.10-275153008
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Procedural Pain; Neonatal Hyperbilirubinemia

Keywords

Phototherapy; Procedural pain; Kangaroo Care

Outcome Measures

Primary Outcomes (6)

• Hearth rate

  hearth rate of the infant in 1 minutes

  30 minutes

• respiratory rate

  respiratory rate of the infant in 1 minutes

  30 minutes

• O2 saturation

  O2 saturation of the infant

  30 minutes

• body temperature

  body temperature of the infant

  30 minutes

• duration of crying

  duration of crying of the infant

  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.

  30 minutes

Study Arms (3)

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.

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.

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.

Behavioral: Routine Care

Interventions

Kangaroo Care BEHAVIORAL

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.

Mother Kangaroo Care; Nurse Kangaroo Care

Routine Care BEHAVIORAL

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.

Standart Care (Control)

Eligibility Criteria

• Age: 2 Days - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 14609899 BACKGROUND

• Lawrence 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.

  PMID: 8413140 RESULT

MeSH Terms

Conditions

Pain, Procedural; Hyperbilirubinemia, Neonatal

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ebru UYGUR, MSc(student)

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebru UYGUR, MSc

CONTACT

05336822564; ebruygurr@gmail.com

Çağrı ÇÖVENER ÖZÇELİK, PhD

CONTACT

ccovener@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)