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

Primary Purpose

Premature, Orogastric Tube, Oral Sucrose

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wrapping + Breastmilk Group
Sponsored by
Ayse Sonay Turkmen, Prof.Dr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature focused on measuring Premature, orogastric tube, oral sucrose, Wrapping

Eligibility Criteria

1 Day - 30 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KaramanogluMehmetbeyU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Wrapping + Breastmilk Group

Wrapping + Oral Sucrose Group

Fetal Position + Breastmilk Group

Fetal Position + Oral Sucrose Group

Arm Description

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.

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).

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.

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.

Outcomes

Primary Outcome Measures

heart rate
heart rate before, during and after the procedure (1st and 2nd min.)
oxygen saturation values
oxygen saturation values before, during and after the procedure (1st and 2nd min.)
PIPP Scale
pain scores before, during and after the procedure (1st and 2nd min.)
comfort scale score
comfort scores before, during and after the procedure (1st and 2nd min.)

Secondary Outcome Measures

Full Information

First Posted
December 17, 2021
Last Updated
November 8, 2022
Sponsor
Ayse Sonay Turkmen, Prof.Dr
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1. Study Identification

Unique Protocol Identification Number
NCT05180058
Brief Title
Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol With Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose
Acronym
OGT
Official Title
Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol With Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ayse Sonay Turkmen, Prof.Dr

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Orogastric Tube, Oral Sucrose
Keywords
Premature, orogastric tube, oral sucrose, Wrapping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wrapping + Breastmilk Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wrapping + Oral Sucrose Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Fetal Position + Breastmilk Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Fetal Position + Oral Sucrose Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Wrapping + Breastmilk Group
Other Intervention Name(s)
Wrapping + Oral Sucrose Group, Fetal Position + Breastmilk Group, Fetal Position + Oral Sucrose Group
Intervention Description
Interventions applied during orogastric tube insertion
Primary Outcome Measure Information:
Title
heart rate
Description
heart rate before, during and after the procedure (1st and 2nd min.)
Time Frame
5 minutes
Title
oxygen saturation values
Description
oxygen saturation values before, during and after the procedure (1st and 2nd min.)
Time Frame
5 minutes
Title
PIPP Scale
Description
pain scores before, during and after the procedure (1st and 2nd min.)
Time Frame
5 minutes
Title
comfort scale score
Description
comfort scores before, during and after the procedure (1st and 2nd min.)
Time Frame
5 minutes

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
premature newborns who gestational week is between 32 and 34 weeks
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
KaramanogluMehmetbeyU
City
Karaman
ZIP/Postal Code
70100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol With Combination of Wrapping, Fetal Position, Breastmilk, and Sucrose

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