Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol with Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose (OGT)

January 9, 2025 updated by: Ayse Sonay Turkmen, Prof.Dr

This study aimed to reduce the pain and increase comfort during the orogastric tube insertion (OGT) procedure, which is routinely applied to feed these babies at 32-34 weeks of age, in preterm newborns with a sucking reflex.In addition, this study also aimed to develop an atraumatic OGT attachment protocol by combining wrapping, fetal position, breast milk and oral sucrose combined therapy.

It was planned as a randomized double-blind and controlled experimental study to evaluate the efficacy of using In addition, this study also planned to develop the atraumatic OGT insertion procedure through combined therapy of wrapping, fetal position, breast milk, and oral sucrose. The population of the research consists of preterm babies who are treated in the Neonatal Intensive Care Unit of Selcuk University Hospital. Babies to be sampled are preterm babies who are between 32 and 34 weeks of gestation.

Preterm newborns will be randomly divided into five groups;

  • Group 1: Control
  • Group 2: Wrapping + breast milk (2 ml)
  • Group 3: Wrapping + oral sucrose (0.2 ml/kg 20% sucrose)
  • Group 4: Fetal position + breast milk (2 ml)
  • Group 5: Fetal position + oral sucrose (0.2 ml/kg 20% sucrose) In the NICU, OGT insertion will be performed by the clinical nurse as part of the treatment for preterm newborns, which the clinic physician deems necessary. The clinical nurse and clinician will be responsible for OGT insertion in preterm newborns. In this study, only wrapping, fetal positioning, oral breast milk and sucrose delivery methods will be applied to preterm newborns by the researcher. In this context, the responsibility of the researcher in the study will be to apply non-pharmacological methods to preterm newborns only before OGT insertion and to evaluate the pain symptoms in preterm newborns during and after OGT insertion.

The obtained data will be evaluated in SPSS-21 package program in computer environment. Normality tests, chi-square, t test, Anova, and advanced analysis will be used when necessary in the analysis of the data. The relationship between the mean score of the scale and other variables will be evaluated by correlation regression analysis. Significance will be accepted as p<0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ethical and institutional permissions were obtained before starting to collect the data. Written consent will be obtained from all parents via a voluntary consent form. Preterm newborns will be randomly selected into 5 groups.

  • Group 1 (Control Group); Wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk methods were not applied to preterms in the routine care group. However, in order to be an ethical practice and to provide ethical standard care intervention, verbal relaxation and soft touch applications were applied by the researcher in the procedure.
  • Group 2 (Wrapping + Breastmilk Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
  • Group 3 (Wrapping + Oral Sucrose Group); Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements).
  • Group 4 (Fetal Position + Breastmilk Group); The fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
  • Group 5 (Fetal Position + Oral Sucrose Group); The fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure.

Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.

Hypotheses (H1) There is a significant difference between the methods applied in the OGT insertion procedure (wrapping+breastmilk, wrapping+sucrose, fetal position+sucrose and fetal position+breastmilk) in terms of heart rate in preterms.

There is a significant difference between the methods applied in the (H2) OGT insertion procedure in terms of oxygen saturation of preterms.

(H3) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated pain score of preterms.

(H4) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the estimated distress score of preterms.

(H5) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the comfort level of preterms.

(H6) There is a significant difference between the methods applied in the OGT insertion procedure in terms of the mean of preterm pain in preterms.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Karaman, Turkey
        • Karamanoğlu Mehmetbey University
      • Karaman, Turkey, 70100
        • KaramanogluMehmetbeyU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gestational week is between 32 and 34 weeks
  • Having breast milk
  • Stable health status
  • Spontaneous breathing
  • Being fed by an orogastric tube
  • Not being exposed to a painful procedure at least half an hour before the interventions
  • Not taking opioid or non-opioid analgesics

Exclusion Criteria:

  • newborns who did not meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wrapping + Breastmilk Group
Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of breast milk will be given by the researcher with a sterile syringe 2 minutes before the OGT insertion to the same newborn. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
Other: Wrapping + Breastmilk Group
Interventions applied during orogastric tube insertion
Other Names:
  • Wrapping + Oral Sucrose Group
  • Fetal Position + Breastmilk Group
  • Fetal Position + Oral Sucrose Group
Experimental: Wrapping + Oral Sucrose Group
Preterm newborns will be wrapped by the researcher 10 minutes before OGT insertion. Then, 2 ml of 20% oral sucrose will be given to the same newborn by the researcher with a sterile syringe 2 minutes before OGT insertion. Oral sucrose will be slowly introduced into the mouth of the preterm newborn on the upper part of the tongue through an injector. Preterm newborns will be recorded with a video camera for 10 minutes before the procedure and for 5 minutes during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at 1 minute before the procedure, during and after the procedure at 1 minute and 2 minutes (4 measurements).
Other: Wrapping + Breastmilk Group
Interventions applied during orogastric tube insertion
Other Names:
  • Wrapping + Oral Sucrose Group
  • Fetal Position + Breastmilk Group
  • Fetal Position + Oral Sucrose Group
Experimental: Fetal Position + Breastmilk Group
The fetal position will be given to the preterm newborn immediately after 2 ml of breast milk is given by the researcher 3 minutes before OGT insertion. Breast milk will be given slowly into the mouth of the preterm newborn, on the upper part of the tongue, through an injector. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure. Newborns will be recorded with a video camera before, during and after the procedure. Then, using video recordings, the pain and comfort of newborns will be evaluated at the 1st minute before the procedure, at the 1st minute and 2nd minute (4 measurements) during and after the procedure.
Other: Wrapping + Breastmilk Group
Interventions applied during orogastric tube insertion
Other Names:
  • Wrapping + Oral Sucrose Group
  • Fetal Position + Breastmilk Group
  • Fetal Position + Oral Sucrose Group
Experimental: Fetal Position + Oral Sucrose Group
The fetal position will be given to the preterm newborn immediately after 2 ml of oral sucrose is given by the researcher 3 minutes before OGT insertion. Oral sucrose will be slowly injected into the mouth of the preterm newborn on the upper part of the tongue by means of an injector. At the end of the 3rd minute, the clinic nurse will insert the OGT as part of the treatment. The preterm newborn will remain in the fetal position for 5 minutes during and after the procedure.
Other: Wrapping + Breastmilk Group
Interventions applied during orogastric tube insertion
Other Names:
  • Wrapping + Oral Sucrose Group
  • Fetal Position + Breastmilk Group
  • Fetal Position + Oral Sucrose Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heart rate
Time Frame: 5 minutes
heart rate before, during and after the procedure (1st and 2nd min.)
5 minutes
oxygen saturation values
Time Frame: 5 minutes
oxygen saturation values before, during and after the procedure (1st and 2nd min.)
5 minutes
PIPP Scale
Time Frame: 5 minutes
pain scores before, during and after the procedure (1st and 2nd min.)
5 minutes
comfort scale score
Time Frame: 5 minutes
comfort scores before, during and after the procedure (1st and 2nd min.)
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ayse Sonay Turkmen, Prof.Dr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • oral nasogastric tube

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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