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

NCT07526233 | Completed

• 1 other identifier: HIEPAIN
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxic-Ischemic Encephalopathy; Pain

Keywords

HIE; mother's scent; octopus; neonate

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Plasebo

NO INTERVENTION

No intervention will be made to this branch

intervention arm

ACTIVE COMPARATOR

This arm will be applied with mother scent and knitted octopus.

Other: scent

Interventions

scent OTHER

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

Also known as: knitted octopus

intervention arm

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Babies with a gestational age of ≥36 and a postpartum age of ≤6 hours.
• Babies diagnosed with asphyxia and receiving TH treatment in the NICU.
• Babies not receiving respiratory support.
• Newborns with family consent.

You may not qualify if:

• Babies with congenital disorders,
• Babies with syndromes/chromosomal disorders,
• Babies who experience seizures while being warmed,
• Babies whose parents wish to withdraw from the study during the study period,
• Babies receiving analgesics

Sponsors & Collaborators

• Alev Sivasli: lead
• Istanbul Nisantasi University: collaborator

Study Sites (1)

Gaziantep Private Anka Hospital

Gaziantep, 27590, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Pain

Interventions

Odorants

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Alev Sivasli

  Nisantasi University, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

• Zerrin Cigdem

  Topkapı University, Istanbul, Turkey

  STUDY DIRECTOR

• Cagri ÇÖVENER ÖZÇELİK

  Marmara University, Istanbul, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor, head of child nursing department

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: April 13, 2026
• Study Start: December 30, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 10, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication

Locations

TU (1)