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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant: A Randomized Controlled Study

Conditions
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Infant, Pain

Intervention / Treatment
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* Behavioral: Sensory Interventions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (mother's voice)<br>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. | Behavioral: Sensory Interventions<br>* Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure. Group 3 will be skin contact with mother's before, during and after the procedure.<br>|
| Experimental: Group 2 (mother's milk)<br>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 | Behavioral: Sensory Interventions<br>* Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure. Group 3 will be skin contact with mother's before, during and after the procedure.<br>|
| Experimental: Group 3 (skin to skin contact)<br>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 | Behavioral: Sensory Interventions<br>* Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure. Group 3 will be skin contact with mother's before, during and after the procedure.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIPS scale | Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases. | Expecting during procedure | 
| NIPS scale | Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases. | 5 minutes after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, pain, mother's milk, mother's voice, skin contact