The Effect of Non-pharmacological Methods on Pain

NCT06455631 | Completed DMC

• 1 other identifier: E-10840098-202.3.02-3029
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm Infant; Oral Breast Milk; Fetal Position; Kangaroo Care; Band Removal; Pain

Outcome Measures

Primary Outcomes (1)

• Pain in preterm infant

  We will assess newborns' pain using the PIPP-R tool before the procedure and at 13, 15, and 17 minutes after starting the procedure.

  Maximum 17 minutes

Secondary Outcomes (3)

• Heart rate

  Maximum 17 minutes

• Oxygen Saturation

  Maximum 17 minutes

• Respiratory rate

  Maximum 17 minutes

Study Arms (3)

Oral Breast Milk and Facilitated Tucking

EXPERIMENTAL

In the facilitated tucking position + oral breast milk group, preterm newborns will be placed in the facilitated tucking position by the researcher 15 minutes before the tape removal procedure and given oral breast milk 2 minutes before the tape removal procedure. The facilitated tucking position will be maintained until 2 minutes after the tape removal procedure. To prevent heat loss, the preterm newborns will be placed in the fetal position inside the incubator by using the incubator windows without opening the incubator lid.

Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo Care

Kangaroo Care and Oral Breast Milk Odor

EXPERIMENTAL

In the kangaroo care + oral breast milk group, preterm newborns will undergo kangaroo care 15 minutes prior to tape removal and receive oral breast milk 2 minutes before. During kangaroo care, mothers can interact with their babies but cannot feed them. After ensuring comfort, this position will be maintained for 15 minutes before tape removal. The nurse will then remove the tape while the baby is in kangaroo care, followed by an additional 2 minutes of kangaroo care. Kangaroo care can continue post-data collection based on maternal preference, baby's condition, and clinical circumstances.

Procedure: Facilitated Tucking, Oral Breast Milk , Kangaroo Care

Control

NO INTERVENTION

The newborns in the control group will undergo the routine nesting procedure of the clinic. All newborns will be placed in the lateral position. For ethical reasons, if babies cry during or after the procedure, gentle touch and verbal comfort will be provided to them.

Interventions

Facilitated Tucking, Oral Breast Milk , Kangaroo Care PROCEDURE

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.

Kangaroo Care and Oral Breast Milk Odor; Oral Breast Milk and Facilitated Tucking

Eligibility Criteria

• Age: 30 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age between 30 and 36+6 weeks
• The newborn not having undergone a painful procedure at least 1 hour before the intervention
• Not having received analgesic and/or sedative medication in the last hour
• Presence of maternal breast milk
• Not having received oral or enteral feeding in the last hour
• Not receiving continuous positive airway pressure (CPAP) or oxygen therapy

You may not qualify if:

• Having ventilator support
• Having a congenital anomaly
• Undergoing continuous sedative treatment
• Having a congenital malformation that could cause asphyxia and affect breathing
• Having intracranial hemorrhage

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahce University

Ataşehir, Istanbul, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Premature Birth

Interventions

Facilitated Tucking; Milk, Human

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Cana Genç, Ph.D student

  Fenerbahce University

  PRINCIPAL INVESTIGATOR

• Duygu Gözen, Ph.D

  Koç University

  STUDY CHAIR

• İrem Baylı, Ms.C

  Medipol hospital

  PRINCIPAL INVESTIGATOR

• Ayhan Taştekin, Dr

  Medipol hospital

  PRINCIPAL INVESTIGATOR

• Negarin Akbari

  Department of Nursing, Faculty of Health Sciences, Fenerbahce University, Istanbul, Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: August 10, 2024
• Primary Completion: February 10, 2025
• Study Completion: February 14, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)