Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT07164820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Su Jok Therapy on Pain During Heel LanceProcedure in Newborn
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
The Effect of Su Jok Therapy on Pain During Heel LanceProcedure in Newborn
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: