The Effect of Su Jok Therapy on Pain During Heel LanceProcedure in Newborn

NCT07164820 | Not Yet Recruiting

• 1 other identifier: Büşra KORKMAZ
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heel Lance Procedures; Pain Management

Keywords

pain; heel lance procedures; Su Jok Therapy; newborn

Outcome Measures

Primary Outcomes (2)

• 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

  12 months

• 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.

  12 months

Study Arms (2)

Su Jok Therapy

EXPERIMENTAL

For newborns who meet the inclusion criteria, the Data Collection Form and the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be completed prior to the procedure. Following the completion of these forms, Su Jok therapy will be applied for 5 minutes. Subsequently, a heel lance procedure will be performed. During and after the procedure, pain assessment will be conducted using the N-PASS.

Other: Su Jok Application

Routine Heel Lance

NO INTERVENTION

For newborns who meet the inclusion criteria, the Data Collection Form and the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be completed prior to the procedure. Following the completion of these forms, routine heel lance will be performed. During and after the procedure, pain assessment will be conducted using the N-PASS.

Interventions

Su Jok Application OTHER

Description: 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

Su Jok Therapy

Eligibility Criteria

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

You may qualify if:

• 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
• Whose parents provided written informed consent
• Who have not received analgesic or sedative medications

You may not qualify if:

• 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
• Infants for whom standardized data could not be collected due to protocol violations

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe AYDIN

  Ataturk University

  STUDY DIRECTOR

Central Study Contacts

Ayşe AYDIN

CONTACT

+905434668220; aysea@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistics expert, Participant
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)