Breast Milk Odor on the Pain and Stress Level of the Newborn Endotracheal Aspiration Procedure

NCT05331846 | Completed

• 1 other identifier: B.30.2.ATA.O.oı.OO/l 8
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aims to determine the effect of breast milk odor on pain and stress in the application of endotracheal aspiration in newborns hospitalized in the Neonatal Intensive Care Unit. The research is planned experimentally with a pretest posttest randomized control group. The research will be carried out in Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022. The population of the study will consist of patients aged 30-28 days who were hospitalized in the Şanlıurfa Training and Research Hospital Neonatal Intensive Care Unit between March-December 2022 and received mechanical ventilation treatment. The research sample; Babies of families who are hospitalized on the dates specified with the probability sampling method and meet the research criteria and volunteer to participate in the research will be formed. Questionnaire Form, Neonatal Pain and Stress Assessment Scale, and Follow-up Form will be used to collect research data. The scent of breast milk will be used as an intervention tool in the research.

Conditions

Endotracheal Aspiration

Outcome Measures

Primary Outcomes (1)

• ALPS Neo Neonatal Pain and Stress Rating Scale

  In 2014, the "Newborn Pain and Stress Rating Scale" was developed based on the individualized developmental care of the newborn in order to evaluate pain and stress in premature and term newborns. In 2017, this scale was adapted to Turkish and validity and reliability studies were conducted. ALPS Neo "Newborn Pain and Stress Assessment Scale" is a 3-point Likert-type scale consisting of 5 items, including "facial expression, breathing pattern, tone of extremities, hand/foot activities and activity level" of the newborn, and measurements are made by observation. As the scores obtained increase, pain and stress increase in the newborn. As a result of the evaluation, "3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress".

  9 MONTHS

Study Arms (2)

SMELL OF BREAST MILK

EXPERIMENTAL

the smell of breast milk will reduce pain and stress

Behavioral: the smell of breast milk

control

NO INTERVENTION

pain and stress will not decrease

Interventions

the smell of breast milk BEHAVIORAL

Smell of breast milk during endotracheal aspiration will reduce pain and stress

SMELL OF BREAST MILK

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being a term newborn,
• to be between 0-28 days,
• Receiving mechanical ventilation support,
• Not taking opioids or sedatives 4 hours before the procedure.

You may not qualify if:

• not be between 0-28 days,
• Not receiving mechanical ventilation support,
• Taking opioids or sedatives 4 hours before the procedure.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Study Officials

• ARZU SARIALİOĞLU, PHD

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 18, 2022
• Study Start: March 19, 2022
• Primary Completion: August 27, 2022
• Study Completion: December 19, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)