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

NCT ID: NCT06567093

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-06-15

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.

Conditions

Pain; Infant ALL

Study Design

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

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Baby Foot and Leg Massage

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Baby Foot and Leg Massage

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.

Intervention Type: OTHER

Eligibility Criteria

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

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).
• problem)
• Newborns planned to be transferred to another hospital

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bartın Unıversity

OTHER

Sponsor Role: lead

Responsible Party

Aylin Kurt

Asst. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bartın University

Bartın, Province, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Aylin Kurt, PhD

Role: CONTACT

aylinkurt67@gmail.com

+905382087211

Facility Contacts

Aylin Kurt, PhD

Role: primary

aylinkurt67@gmail.com

+905382087211

Other Identifiers

2024-SBB-0076

Identifier Type: -

Identifier Source: org_study_id