Effect of Leg and Heel Massage on Pain During Heel Blood Collection Newborns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorBartın Unıversity
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Baby Foot and Leg Massage
Other interventionBaby 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
9 monthsSecondary outcomes
1
Difference of the mean score of the heart rate peak between intervention and control groups
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.
Time frame
9 months2
Difference of the mean score of the oxygen saturation between intervention and control groups
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.
Time frame
9 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov