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

NCT ID: NCT07164820

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-09-01

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.

Detailed Description

This study aims to examine the effect of Su Jok therapy on pain experienced during the heel lance procedure in newborns. Reducing pain associated with heel lance, one of the most commonly performed invasive procedures in the neonatal period, is crucial for the health and comfort of infants. Su Jok therapy is a non-invasive and side-effect-free method applied by stimulating specific points on the hands and feet, and in this study, it is considered as an alternative approach for pain management during heel lance procedures.

The research will be conducted between July 1, 2025, and July 1, 2026, in Family Health Centers affiliated with the Rize Provincial Health Directorate. A total of 66 term newborns (≥37 gestational weeks), consisting of 33 infants in the intervention group and 33 infants in the control group, will be included. The study sample size was determined using G\*Power 3.1.9.7 software. Based on a two-group (experimental, control) and three-measurement (pretest, procedure test, posttest) design with Two-Way Mixed ANOVA analysis, an effect size of 0.20 (f = 0.20), an alpha of 0.05, and a power of 90% (1-β = 0.90) were used, resulting in a required sample of 28 per group. Considering potential data loss, the sample size was increased by 20% per group, leading to a final sample size of 33 per group, 66 in total.

**Inclusion criteria:**

• 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

**Exclusion criteria:**

• 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

From eligible newborns presenting to the centers during the study period, 66 infants will be randomly selected according to the sample size determined by power analysis. Using randomization software, 33 newborns will be assigned to the intervention group and 33 to the control group. Randomization will minimize bias in group allocation. Due to the nature of the study, blinding of the researcher will not be possible; however, blinding will be applied to participants and the statistician. Parents will not know the group allocation of their infants. After the study is completed, coded data from both groups (Group A and Group B) will be analyzed by an independent statistician to ensure objectivity. Thus, the study is planned as a double-blind randomized controlled trial.

**Data collection tools:**

1. **Newborn Introductory Information Form** - prepared by the researcher, including demographic and clinical data (Apgar score, gender, weight, height, head circumference, feeding method). It also records heart rate, oxygen saturation, and crying duration before, during, and after the procedure.

2. **Neonatal Pain/Agitation and Sedation Scale (N-PASS)** - developed for use in all neonates, both term and preterm. It can be used to assess both acute and chronic pain, as well as in infants receiving mechanical ventilator support. The scale includes five subdimensions: crying/irritability, behavior, facial expression, extremity tone, and vital signs. In this study, only the pain/agitation section will be used.

**Intervention procedure:** Newborns meeting inclusion criteria will first undergo baseline data collection (Introductory Information Form and N-PASS). In the intervention group, Su Jok therapy will be applied for 5 minutes immediately before heel lance. The procedure consists of gentle circular massage with mild pressure on specific reflex points on the hand by the researcher, while the newborn is kept in a comfortable position. After the intervention, heel lance will be performed, and pain will be assessed during and after the procedure using N-PASS.

In the control group, baseline forms will be completed, and routine heel lance will be performed without any Su Jok intervention. Pain will be assessed during and after the procedure with N-PASS.

Environmental conditions (room temperature 32-34°C, minimal lighting and noise) will be standardized. Sterile and hygienic practices will be followed, with strict hand hygiene before each application. In both groups, pain assessments will be supported by monitoring heart rate, oxygen saturation, and recovery time. All procedures will prioritize neonatal comfort, safety, and ethical compliance.

Conditions

Heel Lance Procedures; Pain Management

Study Design

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

Study Groups

Su Jok Therapy

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.

Group Type: EXPERIMENTAL

Su Jok Application

Intervention Type: 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

Routine Heel Lance

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Su Jok Application

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Aydin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşe AYDIN

Role: STUDY_DIRECTOR

Ataturk University

Locations

ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ayşe AYDIN

Role: CONTACT

aysea@atauni.edu.tr

+905434668220

Other Identifiers

Büşra KORKMAZ

Identifier Type: -

Identifier Source: org_study_id