The Effect of Su Jok Therapy on Pain During Heel LanceProcedure in Newborn
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-1
SponsorAtaturk University
About this trial
Objective: To determine the effect of Su Jok therapy on pain levels during the heel lance procedure in newborns. The study will be conducted as a randomized controlled experimental trial with a pretest-posttest control group design. The heel lance procedure will be video recorded, and pain assessment will be performed independently by an experienced neonatal intensive care nurse with 7 years of clinical expertise and a neonatologist, using validated pain assessment scales.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Term newborns (≥37 gestational weeks)
Without neurological disorders
Who have not undergone any painful procedure (e.g., injection, venipuncture) in the previous 24 hours
For whom heel lance for routine screening tests is planned
Disqualifiers
Clinically unstable infants before or during the procedure (e.g., respiratory distress, cardiac instability)
Infants whose position was changed, intervention was interrupted, or procedure repeated in a way that could affect pain perception
Parental withdrawal of consent during the procedure
Severe restlessness or sudden physiological changes preventing pain assessment
Trial design
Design model
Parallel
Treatments tested in this trial
Su Jok Application
Other interventionDescription: The newborn's hands will be used for the application. Su Jok therapy will be administered by applying massage and seeds to the corresponding reflection points on the hand prior to the he
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Su Jok TherapyExperimental treatment 1 intervention
Group B: Routine Heel LanceNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neonatal Pain/Agitation and Sedation Scale (N-PASS)
The Neonatal Pain/Agitation and Sedation Scale (N-PASS) was developed by Hummel et al. in 2003 for use in all neonates, both term and preterm. A further advantage of the N-PASS is that it can be used to assess both acute and chronic pain, as well as in infants receiving mechanical ventilator support. The scale was revised by Pat Hummel on October 2, 2009 (Hummel et al., 2008; Hummel et al., 2010). The Turkish adaptation of the scale was performed by Açıkgöz et al. in 2011, who reported Cronbach's Alpha internal consistency coefficients of 0.797 for the pre-procedure period and 0.917 for during and post-procedure. The scale consists of two distinct sections: one for assessing the level of sedation and another for the level of pain. The N-PASS comprises five sub-parameters. These are: crying and irritability, behavior/state, facial expression, extremities (arms/legs) and trunk tone, and vital signs. In pain assessment, each behavioral and physiological criterion
Time frame
12 months2
Neonatal Introductory Information Form
This form was developed by the researcher and includes introductory questions regarding the newborn. The Neonatal Introductory Information Form contains items such as Apgar score, sex, weight, length, head circumference, feeding type, and feeding route. In addition, it includes a section designed to record the newborn's heart rate, oxygen saturation, and crying duration before, during, and after the heel lance procedure.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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