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

NCT06567093 | Recruiting

• 1 other identifier: 2024-SBB-0076
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Infant ALL

Outcome Measures

Primary Outcomes (1)

• Difference of the mean score of the "Newborn Infants Pain Scale" between intervention and control groups

  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.

  9 months

Secondary Outcomes (2)

• Difference of the mean score of the heart rate peak between intervention and control groups

  9 months

• Difference of the mean score of the oxygen saturation between intervention and control groups

  9 months

Study Arms (2)

Experimental

EXPERIMENTAL

All registered participants in the intervention group, will receive the leg and heel massage before the the heel blood collection.

Other: Baby Foot and Leg Massage

Control

NO INTERVENTION

All registered participants in the intervention group, will receive the routine care before the leg and heel massage before the the heel blood collection.

Interventions

Baby Foot and Leg Massage OTHER

Baby Foot Massage stages * The baby is placed on his back, either on the bed or on the couch. * One of the baby's feet is lifted into the air by grasping the back of the ankle. * Start stroking with circular movements, starting from the heel and moving up to the toes. Stroking should be done with the thumb. * Here, it might be good to get between the toes. * The same procedure is applied to the other foot. * Massage is continued until it is noticed that the baby calms down. Baby Leg Massage stages * Start by lifting the leg to be massaged. * Here, the palms of both hands are used. The baby's leg is placed between both hands and the leg is stroked by moving the palms in opposite directions. This movement is continued from above the ankle to the hip. * The same procedure is applied to the other leg. * Massage is continued until the baby calms down.

Experimental

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Sites (1)

Bartın University

Bartın, Province, 74100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aylin Kurt, PhD

CONTACT

+905382087211; aylinkurt67@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: August 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 15, 2025
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months

Locations

TU (1)