Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant

Istanbul University - Cerrahpasa (IUC)

Status: Completed

Conditions: Infant; Pain

Treatments: Behavioral: Sensory Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT05526378

2022/94

Details and patient eligibility

About

Background: Healthy newborns undergo many painful procedures in the first hours of life. Damage caused by painful procedures can lead to structural and functional changes that can affect adult life. Various non-pharmacological methods have been reported in the literature for pain management. The aim of the study is to investigate the effect of the method that appeals to 3 different senses (mother's voice, breast milk smell, mother's contact) on the level of pain during heel blood collection.

Method: The population of the study consisted of babies who were hospitalized in a hospital's neonatal unit between December 2022 and May 2023 and who heel blood taken. The Neonatal-Infant Pain (NIPS) Scale and data collection form were used to obtain the data. 120 newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2 (n=30), group 3 (n=30), control group (n=30). All intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. The mother called her baby between 40 and 60 decibels loudness for group 1. Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm*2,5cm sterile gauze and the gauze was then placed close to the baby's nose wings for group 2. Skin-to-skin contact between mother and baby is provided for group 3. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure for all groups.

Enrollment: 120 patients

Sex: All

Ages: 24 to 48 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Born between 37+0/7 - 41+6/7 gestational weeks,
• Gestational age and birth weight are compatible,
• Healthy newborns with stable vital signs.

Exclusion criteria

• Hearing problems,
• Suction problem
• Congenital anomaly,
• Need hospitalization in the neonatal intensive care unit.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups

Group 1 (mother's voice)

Experimental group

Description:

The mother called her baby between 40 and 60 decibels loudness. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. Benetech brand GM1352 model decibel meter was used to measure the loudness.

Treatment:

Behavioral: Sensory Interventions

Group 2 (mother's milk)

Experimental group

Description:

Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm\*2,5cm sterile gauze. The gauze was then placed close to the baby's nose wings. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure

Treatment:

Behavioral: Sensory Interventions

Group 3 (skin to skin contact)

Experimental group

Description:

Skin-to-skin contact between mother and baby is provided. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure

Treatment:

Behavioral: Sensory Interventions

Control group

No Intervention group