EFFECTS OF TWO PAİN MANAGEMENT EDUCATİON METHODS DURİNG HEEL PRİCK PROCEDURES ON MATERNAL ANXİETY AND NEONATAL PAİN

THE EFFECT OF TWO DİFFERENT PAİN MANAGEMENT EDUCATİON METHODS PROVİDED FOR HEEL PRİCK PROCEDURES ON MOTHERS' USE OF NONPHARMACOLOGİCAL METHODS, ANXİETY LEVELS, AND NEONATAL PAİN

The aim of this research is to evaluate the effects of two different methods of education (verbal instruction + written brochure and verbal instruction + AI-assisted video presentation) given to new mothers on neonatal pain management, their use of non-pharmacological methods, anxiety levels, and neonatal pain, and to examine the relationship between them.

Research Questions Do two different pain management education methods affect mothers' use of nonpharmacological methods? Do two different pain management education methods affect mothers' anxiety levels? Do two different pain management education methods affect neonatal pain during heel prick procedures? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of mothers' use of nonpharmacological methods? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of maternal anxiety levels? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of neonatal pain during heel prick procedures? Is there a relationship between mothers' use of nonpharmacological methods and their anxiety levels? Is there a relationship between mothers' use of nonpharmacological methods and neonatal pain levels?

Study Overview

• Status: Completed
• Conditions: Infant; Postpartum Anxiety; Newborn Pain; Infant Care; İnfant Comfort; Nonpharmacological Interventions
• Intervention / Treatment: Other: verbal and brochure-based education; Other: verbal and AI-supported video training

Detailed Description

The International Association for the Study of Pain has defined pain as "an unpleasant sensory and emotional experience associated with actual or potential injury" (IASP, 1979). However, it has been noted that this definition is insufficient in newborns, who lack verbal communication, as they cannot express pain and have no opportunity to refuse treatment (Anand & Craig 1996), and later, pain was redefined as an unpleasant sensory and emotional experience associated with or similar to actual or potential tissue damage (Raja et al. 2020). Newborns are frequently exposed to painful procedures during diagnostic and therapeutic processes such as routine newborn screenings, blood glucose measurement, and immunization (WHO, 2017). It has been reported that painful interventions experienced in early childhood can lead to short-term physiological changes as well as neurodevelopmental consequences (AAP 2016; Hatfield & Ely, 2015). Furthermore, it has been shown that exposure to painful stimuli in early life may be associated with stress responses and behavioral changes later in life (Taddio et al. 1997). The first step in pain management is the accurate assessment of pain. Therefore, it is important to use validated scales in the assessment of pain in newborns and to apply appropriate pain management methods (Costa et al. 2017; Rocha et al. 2021). Although pharmacological methods are frequently used in pain management in infants, interest in non-pharmacological methods has increased in recent years due to the physiological immaturity of newborns and possible side effects of drugs (Allegaert and van den Anker, 2017). Methods such as holding, non-nutritive sucking, breastfeeding, sucrose/glucose solutions, skin-to-skin contact, and swaddling are reported to be effective in reducing pain scores during short-term painful procedures (Mangat et al. 2018). The American Academy of Pediatrics recommends that families be actively involved in the prevention and management of pain in newborns (American Academy of Pediatrics, 2016). Within the framework of the family-centered care approach, parental participation in the care of their babies is encouraged, and it is reported that the education given to parents increases the use of pain management methods (Taddio et al. 2013; Campbell-Yeo et al. 2017; Chambers et al. 2020). However, studies that evaluate the effects of different education methods given to mothers during heel prick blood sampling, one of the frequently performed painful procedures in newborns, on mothers' anxiety levels, non-pharmacological method use, and newborn pain are limited. Therefore, this study aimed to determine mothers' approaches to pain management during heel prick blood sampling performed within the scope of newborn screening and to evaluate the effects of two different education methods given before the procedure on mothers' use of non-pharmacological methods, anxiety levels, and newborn pain.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • İ̇zmi̇t
    • Kocaeli, İ̇zmi̇t, Turkey (Türkiye)
      • Kocaeli University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Being 19 years of age or older Being a primiparous mother Voluntarily agreeing to participate in the study Not having a psychiatric diagnosis Having a healthy term newborn baby (born at 38-42 gestational weeks) Having a blood sample taken for the Guthrie screening test

Exclusion Criteria:

Lack of Turkish reading and comprehension skills in the participant Incomplete completion of the survey form Having a baby with a congenital anomaly Having received any analgesia before the procedure Refusal to have a blood sample taken for the Guthrie screening test History of the baby staying in intensive care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The mothers underwent the clinic's routine procedure.
Experimental: verbal and brochure-based education; Mothers were given training on non-pharmacological pain management through verbal and brochure education.	Other: verbal and brochure-based education; Non-pharmacological pain management methods for newborns were explained to mothers verbally and through brochures during heel prick blood tests.
Experimental: verbal and AI-assisted video training; Mothers were given training in non-pharmacological pain management through verbal instruction and AI-assisted video training.	Other: verbal and AI-supported video training; Non-pharmacological pain management methods for newborns were explained to mothers through verbal and AI-supported video training during heel prick blood sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mothers' anxiety	Those scoring between 20 and 80 points indicate anxiety.	between 24 and 72 hours after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn Pain Scale (NIPS)	The scale consists of six parameters: facial expression, crying, breathing, arm movements, leg movements, and sleep-wake status.	between 24 and 72 hours after birth

Collaborators and Investigators

• Sponsor: Kocaeli University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): May 1, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024/256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No