MedTrace Logo

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

NCT07125690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-15

No results posted yet for this study

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.

Conditions

  • Neonatal Pain
  • Non-Pharmacological Pain Management

Interventions

OTHER

local heat application

The newborns included in this group received local dry heat application 5 minutes before the heel prick procedure, with the newborn in the supine position. Local dry heat was applied using a thermometer heated with water between 40 and 45˚C. The temperature of the water inside the thermometer was measured before application. The thermometer was applied to the sole of the newborn's right foot. Contact with bare skin was prevented, and the thermometer was used in a protective cover.

OTHER

oral sucrose

In accordance with the Neonatal Pain and Treatment Guidelines, a total of 1 ml of sucrose at a 24% concentration recommended for full-term infants was prepared in a syringe. It was administered to the anterior tongue 2 minutes before the heel prick

OTHER

mixed group

Newborns included in the combined intervention group received local dry heat with a thermometer heated with water at 40-45˚C 5 minutes before blood collection, with the infant in the supine position. At the third minute of the local heating, 1 ml of 24% sucrose was applied to the anterior tongue over 1 minute. A stopwatch was used to monitor the procedure times.

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Principal Investigators

  • fatma gul tamer · TC Erciyes University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
31 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2023-12-11
Completion
2024-06-03

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07125690 on ClinicalTrials.gov