Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05180058
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2021-12-17
Brief Title:
Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol With Combination of Wrapping Fetal Position Breastmilk and Sucrose
Sponsor:
Ayse Sonay Turkmen ProfDr
Organization:
Karamanoğlu Mehmetbey University
Study Overview
Official Title:
Development and Efficiency of Atraumatic Orogastric Tube Insertion Protocol With Combination of Wrapping Fetal Position Breastmilk and Sucrose
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OGT
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 reflexIn 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 02 mlkg 20 sucrose
Group 4 Fetal position breast milk 2 ml
Group 5 Fetal position oral sucrose 02 mlkg 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 p005
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 02 mlkg 20 sucrose
Group 4 Fetal position breast milk 2 ml
Group 5 Fetal position oral sucrose 02 mlkg 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 p005
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 Wrappingbreastmilk wrappingsucrose fetal positionsucrose and fetal positionbreastmilk 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 wrappingbreastmilk wrappingsucrose fetal positionsucrose and fetal positionbreastmilk 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
Group 1 Control Group Wrappingbreastmilk wrappingsucrose fetal positionsucrose and fetal positionbreastmilk 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 wrappingbreastmilk wrappingsucrose fetal positionsucrose and fetal positionbreastmilk 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None