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

Alev Sivasli45 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Conditions

Hypoxic-Ischemic Encephalopathy Pain

Interventions

scentOTHER

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

Eligibility

Sex: ALLMax age: 28 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Babies with a gestational age of ≥36 and a postpartum age of ≤6 hours. 2. Babies diagnosed with asphyxia and receiving TH treatment in the NICU. 3. Babies not receiving respiratory support. 4. Newborns with family consent. Exclusion Criteria: 1. Babies with congenital disorders, 2. Babies with syndromes/chromosomal disorders, 3. Babies who experience seizures while being warmed, 4. Babies whose parents wish to withdraw from the study during the study period, 5. Babies receiving analgesics

Locations (1)

Gaziantep Private Anka Hospital

Gaziantep, Turkey (Türkiye)

Outcomes

Primary Outcomes

N-PASS Pain Score

The Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be used to assess pain levels in newborns undergoing therapeutic hypothermia. The scale evaluates behavioral and physiological parameters, with higher scores indicating increased pain.

Time frame: From 6 hours after initiation of therapeutic hypothermia up to 72 hours (assessed every 3 hours)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.