Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06567093

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bartın University

Bartın, Province, 74100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Aylin Kurt, PhD

CONTACT

[email protected]

+905382087211

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aylin Kurt, PhD

CONTACT

[email protected]

+905382087211

Sponsors and collaborators

Lead sponsor

Bartın Unıversity

Other

Registry information

Official study title

Effect of Leg and Heel Massage on Pain Experienced During Heel Blood Collection and Physiological Parameters in Newborns: Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.