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

NCT ID: NCT07125690

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2024-06-03

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.

Conditions

Neonatal Pain; Non-Pharmacological Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Local Heat Application to the Heel

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.

Group Type: ACTIVE_COMPARATOR

local heat application

Intervention Type: 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.

Oral Sucrose Administration

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.

Group Type: ACTIVE_COMPARATOR

oral sucrose

Intervention Type: 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

Local Heat and Oral Sucrose Application to the Heel

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.

Group Type: ACTIVE_COMPARATOR

mixed group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 31 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

FATMA GUL TAMER

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

fatma gul tamer

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

Erciyes University

Kayseri, Kayseri, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ErciyesU.FGTamer.01

Identifier Type: -

Identifier Source: org_study_id