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

NCT07125690 | Completed

• 1 other identifier: ErciyesU.FGTamer.01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Pain; Non-Pharmacological Pain Management

Keywords

neonatal; procedural pain; heel lancing; local heat applications; oral sucrose

Outcome Measures

Primary Outcomes (2)

• ALPS-Neo Pain and Stress Assessment Scale

  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).

  6 month

• Newborn Infant Pain Scale (NIPS)

  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.

  6 month

Study Arms (3)

Local Heat Application to the Heel

ACTIVE COMPARATOR

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: local heat application

Oral Sucrose Administration

ACTIVE COMPARATOR

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: oral sucrose

Local Heat and Oral Sucrose Application to the Heel

ACTIVE COMPARATOR

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.

Other: mixed group

Interventions

local heat application OTHER

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.

Local Heat Application to the Heel

oral sucrose OTHER

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

Oral Sucrose Administration

mixed group OTHER

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.

Local Heat and Oral Sucrose Application to the Heel

Eligibility Criteria

• Age: 3 Days - 31 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• fatma gul tamer

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: During the application, the family of the participating newborns does not know which group they will be included in. Experts who used pain scales to evaluate the videos used during the application. And they did not know which group the newborn were in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: The process will be explained using the consent forms distributed to births that meet the inclusion criteria, and written consent will be obtained from the families. A Newborn and Family Identifying Information Form was first completed for the babies to be included in the study.For all groups to be included in the study, before the heel blood was taken, the Newborn Infant Pain Scale (NIPS), ALPS-Neo and physiological parameters were recorded on video with the babies' entire bodies visible, starting 6 minutes before the procedure, continuing during the procedure and ending 2 minutes after the procedure.The heel prick blood collection procedure was performed by the same healthcare professional each time, with the babies in the same position, and the data collection was performed by the researcher.

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: December 11, 2023
• Primary Completion: December 11, 2023
• Study Completion: June 3, 2024
• Last Updated: August 15, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)