Effect of Two Non-pharmacological Method on Pain, Stress Procedure Duration in Newborn

Not Applicable

Completed

• Conditions: Neonatal Pain; Non-Pharmacological Pain Management

• Registration Number: NCT07125690
• Lead Sponsor: TC Erciyes University

Brief Summary

This study is planned as a prospective, single-blind, randomized controlled experimental study matched according to gestational age, gender, and birth weight, to determine the effects of local heat application and oral sucrose use during heel prick blood collection on pain, stress, procedure duration, and physiological parameters of newborns.

Detailed Description

Non-pharmacological methods are important alternatives for managing pain caused by minimally invasive procedures performed on newborns. Applying local heat to the heel, one of the non-pharmacological methods that can be used to reduce pain during heel prick in newborns, suppresses pain escalation by activating the gate-control mechanism, reduces pain, stimulates sensory receptors, and induces vasodilation. It also reduces ischemic pain, promotes the removal of metabolic waste, increases endorphin release, inhibits muscle contraction, reduces the effects of pressure, and provides pain relief for newborns.

Another non-pharmacological method used for pain management in newborns is oral sucrose administration. Used as an analgesic in minor invasive procedures, sucrose activates the endogenous opioid system by stimulating the sense of taste. Oral sucrose administration is an easily administered, proven, readily available, inexpensive, and rapidly effective method.

Authorities have an important role to play in minimizing the negative effects of various invasive procedures and cutting procedures, and protecting the baby from the short- and long-term effects of pain. Natural, economical, and easily curative methods for reducing pain during heel punctures include sucrose administration and topical heat application to the heel, among the herbal solutions offered by Mothers and Organics.Various non-pharmacological methods have been investigated in the literature for their effects on pain during heel prick blood sampling, and the positive effects of sucrose injection and heat application to the heel have also been reported. However, studies have generally focused on the use of sucrose injection and local heat application to the heel alone for pain reduction. There is no study evaluating their combined use in the same sample and comparing their effects.Therefore, this study aims to determine the effects of local heat application to the heel and oral sucrose administration during heel prick blood collection on the pain, stress, physiological parameters, and procedure duration of newborns.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-11
• Primary Completion: 2023-12-11
• Study Completion: 2024-06-03
• Study First Submitted: 2025-08-09
• Study First Submitted QC: 2025-08-09
• Last Update Submitted: 2025-08-09
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 38-42 weeks gestational age,
• birth weight ≥ 2500 g,
• stable vital signs,
• no congenital anomalies,
• no congenital illnesses at birth such as neonatal asphyxia, hemolytic status, metabolic disease, skin disease, patent ductus arteriosus (PDA), respiratory distress syndrome (RDS), and sepsis,
• no intracranial hemorrhage,
• not taking any medications other than antibiotics and vitamin supplements,
• not fed or changed within 30 minutes before the heel prick,
• not taking opioids or sedatives within 4 hours before the heel prick,
• not undergoing any painful procedures at least one hour before the heel prick,
• newborns whose mothers gave verbal and written informed consent

Exclusion Criteria

• Newborns who exhibited signs of infection (gastroenteritis, sepsis, etc.) during the study,
• Blood collection was not possible on the first attempt,
• Newborns whose mothers wished to withdraw from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ALPS-Neo Pain and Stress Assessment Scale	6 month	The ALP-Neo performance is a three-point Likert-type scale consisting of five items: the subject's facial expression, breathing pattern, extremity tone, hand and foot activity, and activity level. Measurements are made through observation. The resulting score reflects increased stress and pain (3-5 points = mild pain and stress; \>5 points = severe pain and stress).
Newborn Infant Pain Scale (NIPS)	6 month	The scale consists of five behavioral parameters, including facial expression, crying, breathing pattern, arm and leg movements, and alertness, and one physiological parameter that tracks breathing pattern. Each behavior except crying is scored from 0 to 1, and the crying parameter is scored from 0, 1, and 2. The NIPS scores range from 0 to 7, with 0-2 indicating no pain, 3-4 indicating moderate pain, and \>4 indicating severe pain. Cronbach's alpha coefficients for the scale were calculated as 0.95, 0.87, and 0.88 before, during, and after the intervention, respectively.

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Kayseri, Turkey