Effect of Leg and Heel Massage on Pain During Heel Blood Collection Newborns

Not Applicable

Recruiting

• Conditions: Infant ALL; Pain
• Interventions: Other: Baby Foot and Leg Massage

• Registration Number: NCT06567093
• Lead Sponsor: Bartın Unıversity

Brief Summary

This study was planned to evaluate the effect of leg and heel massage on newborns, the pain experienced during heel blood collection, and the effects on physiological parameters.

H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group.

H2: Heart rates are lower in leg and heel massage group than control group. H3: Oxygen saturation levels are higher in leg and heel massage group than control group.

Detailed Description

In this study, there will be two groups as the intervention (who will receive leg and heel massage) and the control group (who will receive routine care). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 30 cases in each group would be sufficient for 80% power. Infants who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The heel blood collection will be applied to both the intervention and control groups. For children in the massage group, the massage will be applied to both legs and heels of the baby. Immediately before the procedure, each leg and heel will be massaged for three minutes. The control group will receive heel blood collection with routine care. A researcher and a nurse were employed for the heel blood collection both for the intervention and control groups. A pediatric nurse performed the heel blood collection for all infants and the other researcher helped the children to assess their pain, heart rates and Oxygen saturation. Measurements 5 minutes before the heel prick procedure, during the procedure (1st minute) and 5 minutes after the heel prick application. The heel blood collection will be performed by the same nurse both in the intervention and control groups.

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-15
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-05-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Gestational age is 38-41 weeks,
• The birth weight of the newborn is >2500 g
• Vital signs should be stable before the procedure,
• Postanatal age is between 2-28 days,
• There are no contraindications for the application of massage
• Delivery of the newborn to the mother after birth
• Permission of the parents of the newborn participating in the research
• Fasting period less than 3 hours/fed 30 minutes before
• A newborn who does not cry before heel blood is taken

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Exclusion Criteria

• Newborns who need respiratory support,
• Newborns with any neurological disorders (seizures)
• Newborns using opioids or babies born to mothers using opioids
• Newborns taking muscle relaxants, sedatives, analgesics
• Babies with major congenital anomalies
• Babies with an APGAR score of less than 7 in 5 minutes,
• Newborns who have undergone any surgery
• Newborns with birth trauma (especially rapid births)
• There are situations that may prevent communication with parents (e.g. language problems).
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• Newborns planned to be transferred to another hospital

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Baby Foot and Leg Massage	All registered participants in the intervention group, will receive the leg and heel massage before the the heel blood collection.

Primary Outcome Measures

Name	Time	Method
Difference of the mean score of the "Newborn Infants Pain Scale" between intervention and control groups	9 months	Pain assessment will be made with the "Newborn Infants Pain Scale". The "Newborn Infants Pain Scale" will be measured again during the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick. At the end of the study, the change of the mean score of "Newborn Infants Pain Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.

Secondary Outcome Measures

Name	Time	Method
Difference of the mean score of the heart rate peak between intervention and control groups	9 months	Heart rate peak, which is a physiological parameter, will be evaluated. During the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick application, the heart rate will be measured again. At the end of the study, the change of the mean score of "peak heart rate" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Difference of the mean score of the oxygen saturation between intervention and control groups	9 months	Oxygen saturation value, which is a physiological parameter, will be evaluated. Oxygen saturation will be measured again during the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick application. At the end of the study, the change of the mean score of "oxygen saturation" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.

Trial Locations

Locations (1)

Bartın University; 🇹🇷 Bartın, Province, Turkey