NCT07526233

The Effect of Maternal Scent and Knitted Octopus Application on Pain in Infants Diagnosed With Neonatal Asphyxia and Receiving Therapeutic Hypothermia Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Alev Sivasli · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

Summary

This study was designed to determine the effects of maternal scent and knitted octopus application on pain in infants born with asphyxia beyond 36 weeks' gestation and receiving Therapeutic Hypothermia (TH) treatment in the Neonatal Intensive Care Unit (NICU) of Gaziantep Private Anka Hospital. The study is a randomized controlled experimental study. Block randomization will be used as the randomization method.

Detailed description

Detailed Description The neonatal period is characterized by increased sensitivity to environmental stimuli, including olfactory inputs. Early exposure to maternal odors may support physiological stability and behavioral regulation in newborns. In neonatal intensive care settings, maternal scent is commonly introduced using odor-bearing materials placed near the infant. In addition, supportive positioning tools such as soft objects may provide comfort and reduce stress-related responses. This randomized controlled trial is designed to evaluate the effects of maternal scent exposure and the use of a knitted octopus on pain response in newborns undergoing therapeutic hypothermia for perinatal asphyxia. Participants will be randomly assigned to receive either maternal scent exposure, a knitted octopus intervention, or standard care. Maternal scent exposure will be provided using maternal clothing and odor-absorbing materials placed near the infant to allow continuous exposure throughout the treatment period. The knitted octopus intervention involves placing a soft, hypoallergenic object in contact with the infant to provide tactile comfort. Pain assessments will be performed at predefined intervals during the therapeutic hypothermia period using a validated neonatal pain scale. Data will be collected prospectively and analyzed to compare pain responses between groups. The study aims to determine whether these non-pharmacological interventions can reduce pain and improve comfort in newborns receiving therapeutic hypothermia.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Pain

Interventions

Type	Name	Description
OTHER	scent	We believe that exposure to the mother's scent and hugging the baby to a knitted octopus will reduce pain in the baby.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-10-01
• Completion: 2025-10-10
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)