The Effect of Non-pharmacological Methods on Pain

Summary

The research will be conducted using a randomized controlled experimental method.The preterm newborns included in the study will be randomized into three groups using the sealed envelope method. In the facilitated tucking position + oral breast milk group, preterm newborns will be placed in the facilitated tucking position 15 minutes before tape removal and given oral breast milk 2 minutes before. This position will be maintained until 2 minutes after tape removal. Preterm newborns in the kangaroo care + oral breast milk group will undergo kangaroo care 15 minutes before tape removal and receive oral breast milk 2 minutes before. Kangaroo care allows mother-baby interaction but no feeding. In the control group, newborns will undergo routine nesting with gentle touch and verbal comfort provided if they cry.This study is designed to evaluate the effect of the fetal position, oral breast milk administration, and kangaroo care on pain during tape removal in preterm newborns.

Conditions

• Pain
• Infant ALL
• Preterm

Interventions

PROCEDURE

Facilitated Tucking, Oral Breast Milk , Kangaroo Care

Before data collection, the researcher will inform families of newborns meeting the sample criteria about the study and obtain written consent from participating parents. Newborn and parent information will be recorded. Procedures will occur between 08:00 and 16:00, with one researcher, two nurses, and a preterm newborn present during tape removal. Tape removal will be done by the same nurse. Physiological and behavioral responses will be recorded before, during, and after tape removal. Breast milk will be orally administered during tape removal, with the amount adjusted based on gestational age. Measurements will be taken at specified time points, including heart rate, respiratory rate, oxygen saturation, and PIPP-R score. These procedures will also apply to the control group. PIPP-R scores will be recorded by two evaluators based on video recordings.

Sponsors & Collaborators

• Fenerbahce University

  lead OTHER

Principal Investigators

• Cana Genç, Ph.D student · Fenerbahce University

• Duygu Gözen, Ph.D · Koç University

• İrem Baylı, Ms.C · Medipol hospital

• Ayhan Taştekin, Dr · Medipol hospital

• Negarin Akbari · Department of Nursing, Faculty of Health Sciences, Fenerbahce University, Istanbul, Turkey

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Weeks

Max Age

36 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-08-10

Primary Completion

2025-02-10

Completion

2025-02-14

Countries

• Turkey (Türkiye)

Study Locations