Reducing Pain During Orogastric Tube Insertion in Newborns: Use of Pacifiers and Pacifiers Sweetened With 25% Dextrose

NCT05462964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-18

No results posted yet for this study

Summary

Orogastric tube(OGT) placement, which is used for monitoring, diagnostic and therapeutic purposes, causes pain and stress in premature and term newborns. Non-pharmacological pain intervention with pacifiers and sweetener solutions (sucrose, dextrose, etc.) in newborns is a viable nursing approach to reduce pain. In the limited number of studies in the literature, it was seen that pacifiers and sucrose were used in nasogastric tube(NGT) applications and they were especially focused on premature babies. In our study, due to the fact that it was conducted in term newborns and, unlike the limited number of studies, OGT was placed in the stomach in the form of a pacifier and a 25% dextrose pacifier leaking from the rim. Our study was conducted as a randomized controlled experimental study to examine the effect of using pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement, and also to evaluate the effects on behavioral response and physiological parameters (heart rate, oxygen saturation) in newborns.In addition, it was thought that the fact that the study was carried out by passing a pacifier and a pacifier sweetened with 25% dextrose, would facilitate progress and reduce trauma by stimulating the swallowing reflex in newborns via a pacifier as in adults.The population of the study consisted of term newborns at 38-42 weeks of gestation who were hospitalized in the Neonatal Intensive Care Unit of a hospital in Turkey between April-December 2019. The sample group randomly consisted of 60 newborns (Control group: 20, Intervention group with only pacifiers:20, with dextrose flavored pacifiers:20). 20 babies in the intervention group were given only pacifiers and 20 babies were given a pacifiers flavored with dextrose 2 minutes before the OGT insertion. The procedure was performed by leaking the tube from the edge of the pacifiers. Routine OGT insertion was performed in the control group. The data collection process was recorded with a camera. The Neonatal Infant Pain Scale (NIPS), the highest heart rate and lowest oxygen saturation from physiological pain responses, and crying time from behavioral parameters were evaluated by the researcher by watching the camera recording. Variance analysis, Shapiro Wilk, Kruskal Wallis, Chi-square, Bonferro, and Wilcoxon tests were used in the statistical analysis of the study. The SPSS v22 package program was used for statistical analysis and the significance level was taken at α=0.05.

Conditions

Interventions

BEHAVIORAL

Pacifiers Group (İntervention Group 1)

Camera recording was started 2 minutes before OGT placement and only a pacifier was given to the newborn. After the pacifier in the OGT intervention group was placed in the mouth of the given baby in the form of leaking from the mouth, it was inserted by advancing the baby's swallowing reflex from the esophagus to the stomach. It was checked whether the orogastric tube was in the right place. After the evaluation period was completed and the baby was comfortable, the recording was stopped.

BEHAVIORAL

Pacifier group sweetened with 25% dextrose (İntervention Group 2)

Camera recording was started 2 minutes before OGT insertion and the newborn was given a pacifier sweetened with 25% dextrose. After the dextrose-sweetened pacifier in the OGT intervention group was placed in the mouth of the baby in the form of a leak from the mouth, it was inserted by advancing the baby's esophagus and then to the stomach with the swallowing reflex of the baby. It was checked whether the orogastric tube was in the right place. After the evaluation period was completed and the baby was comfortable, the registration was stopped.

Sponsors & Collaborators

  • Uludag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
38 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-25
Primary Completion
2020-02-18
Completion
2020-02-18

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05462964 on ClinicalTrials.gov