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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hypoxic-Ischemic Encephalopathy
• Intervention / Treatment: Other: scent

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Gaziantep, Turkey (Türkiye), 27590
    • Gaziantep Private Anka Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Plasebo; No intervention will be made to this branch
Active Comparator: intervention arm; This arm will be applied with mother scent and knitted octopus.	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.; Other Names: knitted octopus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From 6 hours after initiation of therapeutic hypothermia up to 72 hours (assessed every 3 hours)

Collaborators and Investigators

• Sponsor: Alev Sivasli
• Collaborators: Istanbul Nisantasi University
• Investigators: Principal Investigator: Alev Sivasli, Nisantasi University, Istanbul, Turkey; Study Director: Zerrin Cigdem, Topkapı University, Istanbul, Turkey; Study Director: Cagri ÇÖVENER ÖZÇELİK, Marmara University, Istanbul, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HIE; neonate; mother's scent; octopus
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Signs and Symptoms, Respiratory; Hypoxia, Brain; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Hypoxia-Ischemia, Brain; Environment and Public Health; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Odorants
• Other Study ID Numbers: HIEPAIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No