Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438731
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-27
Brief Title:
Comparison of Two Methods in Pain Caused by Orogastric Tube Placement in Preterm Newborns
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
The Effect of Breast Milk and Knitted Octopus on the Pain Caused by Orogastric Tube Insertion in Preterm Newborns
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Aim This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns
Method This study was planned as a randomized controlled trial The study group will consist of 66 preterms with a gestational age of 32-34 weeks fed by orogastric tube Informed Consent Form Preterm Newborn Introduction Form Physiologic Parameters Measurement Form and Premature Infant Pain Profile PIPP will be used in the study The research will be conducted in the Neonatal Intensive Care Unit of a university hospital in Denizli province Newborns in the breast milk group will be given oral breast milk before the procedure Newborns in the knitted octopus group will be provided with the octopus touching various parts of their bodies as a tactile stimulation before the procedure No intervention will be performed on newborns in the control group Data will be obtained by the researcher from camera recording and patient file In evaluating the data continuous variables will be given as mean standard deviation and categorical variables will be given as number and percentage Parametric and non-parametric tests will be used to examine the differences between groups
Hypothesis It is expected to contribute to the development of a new approach in the pain management of preterm newborns by evaluating the effectiveness of breast milk and knitted octopus in reducing the pain caused by orogastric tube insertion in preterm newborns
Method This study was planned as a randomized controlled trial The study group will consist of 66 preterms with a gestational age of 32-34 weeks fed by orogastric tube Informed Consent Form Preterm Newborn Introduction Form Physiologic Parameters Measurement Form and Premature Infant Pain Profile PIPP will be used in the study The research will be conducted in the Neonatal Intensive Care Unit of a university hospital in Denizli province Newborns in the breast milk group will be given oral breast milk before the procedure Newborns in the knitted octopus group will be provided with the octopus touching various parts of their bodies as a tactile stimulation before the procedure No intervention will be performed on newborns in the control group Data will be obtained by the researcher from camera recording and patient file In evaluating the data continuous variables will be given as mean standard deviation and categorical variables will be given as number and percentage Parametric and non-parametric tests will be used to examine the differences between groups
Hypothesis It is expected to contribute to the development of a new approach in the pain management of preterm newborns by evaluating the effectiveness of breast milk and knitted octopus in reducing the pain caused by orogastric tube insertion in preterm newborns
Detailed Description:
İNTRODUCTİON Preterm babies experience many problems in the postnatal period because they are anatomically and physiologically immatureNutritional problems have an important place among these problemsIn the first days of life they are fed enterally via orogastric tube Enteral nutrition is the process of giving the newborns nutrition through a nasogastric NG orogastric OG or transpyloric tubeBaby feeding tube insertion causes painAlthough in the past years it was said that the newborn did not feel pain the prenatal starts to feel it from the 20th week When pain is not detected the growth and development of the newborn is negatively affectedThere are pharmacological and non-pharmacological methods in pain management
Touch is considered the most basic communication and is well developed Breast milk increases immunity and ensures growth and developmentThe sense of taste is highly developed even in premature babies
There is no study in the literature comparing breast milk and the knitting octopus method togetherConsidering that orogastric tube application in newborns is a common clinical practice it is important to minimize the side effects of this treatment method and increase the comfort of babies
Aim of the study This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm neonates
Materials and Methods
Type of Research The research will be conducted as a randomized controlled study
Location Characteristics and Time Where the Research Was Conducted The study will be conducted between March 2024 and March 2026 in preterm neonates who received an orogastric tube in the neonatal intensive care unit of a university hospital in a province in the western region of Turkey In the hospital where the study was conducted there are level 3 level 2 and maternal adaptation room in the neonatal intensive care unit Approximately 31 nurses and 2 specialist doctors work in the neonatal intensive care unit
Population and Sample of the Study The study population will consist of newborns who received treatment and care in the Neonatal Intensive Care Unit of a university hospital in a province in the western region of Turkey between March 2024 and March 2026 and who meet the case selection criteria
The study sample will consist of preterm newborns with a gestational age of 32-34 weeks treated in the Neonatal Intensive Care Unit of the same hospital Infants fed with orogastric catheter in the neonatal intensive care unit will be included in the sample The effect size obtained in the reference study was found to be strong F0695 Şener Taplak and Erdem 2017 Assuming that a lower effect size F04 could be obtained as a result of the power analysis performed for 3 groups it was calculated that 80 power could be obtained at 95 confidence level when at least 66 infants at least 22 infants for each group were included in the study
Randomization Randomization in the research will be provided by the sealed envelope method In the case of an infant meeting the sampling criteria after obtaining signed informed consent from the parent the researcher will give the newborn a letter placed in a sealed envelope and the newborns will be randomly assigned to groups Which letter will represent which group will be determined at the beginning of the study using the closed opaque envelope method Accordingly letter C will be used for the control group letter B for the knitted octopus group and letter A for the breast milk group
Blinding Single blinding participants will be used in the study Participants will not be informed about which group they are in
Research Inclusion Criteria
Gestational week between 32-34 weeks
Postnatal age 37 weeks
Having breast milk
Weighing 1000 grams or more
Spontaneous breathing
Being fed with an orogastric tube
Not being exposed to a painful procedure at least half an hour before the interventions
Parental consent for the newborn to participate in the study
Criteria for Exclusion from the Study
Having received ventilator support may have received it before
Any congenital anomaly of the face or oral cavity
Grade 3 and 4 intraventricular hemorrhage
Taking opioid or non-opioid analgesics
Repeated orogastric tube placement
Application
After the parents accept the study and complete the Informed Consent Form the Preterm Newborn Introduction Form will be completedPain level will be evaluated by interpreting the camera image in accordance with the physiologic parameters measurement form and Premature Infant Pain Profile
Orogastric tube application is applied in neonatal intensive care unit to babies who cannot take by mouthOrogastric tubes can be changed daily or during the day according to the needs of the newborn
Since the pain level of breast milk knitted octopus and control group will be recorded with a camera during the orogastric catheter insertion procedure the procedure will be performed only once
Breast Milk Group Preterm newborns in this group will be administered their own mothers milk with a sterile syringe as 1 ml single dose 2 minutes before orogastric tube insertion During administration the baby will not be allowed to suck the tip of the syringe and breast milk will be dripped onto the tongue Nothing oral will be given 30 minutes before the procedure Preterm newborn will be monitored by camera recording for 5 minutes before during and 5 minutes after the procedure
Knitted Octopus Group The knitted octopus method will be applied to preterm newborns in this group before orogastric tube insertion The arms of the knitted octopus will wrap around the babys arms and legs and its head will be on the babys body The preterm newborn will be monitored by camera recording for 5 minutes before the procedure and for 5 minutes during and after the procedure
Control Group For preterm newborns in this group no method will be applied before orogastric tube insertion and routine procedures will be performed The preterm will be monitored for 5 minutes before birth during the procedure cycle and then by camera recording for 5 minutes
Data Collection Tools
Informed Consent Form Annex 1 It will include information such as the purpose of the research that participation is voluntary and that personal information will be kept confidential
Preterm Newborn Introduction Form Annex 2 The form prepared by the researcher will include the group in which the newborn is included mode of delivery 1st and 5th minute apgar score birth weight gender gestational age postnatal age and duration of orogastric catheter insertion
Physiological Parameters Measurement Form Annex 3 This form prepared by the researcher will help evaluate the pain heart rate and oxygen saturation value while the orogastric tube is inserted This form is preterm It was created to record the babys heart rate and oxygen saturation value During orogastric tube insertion heart rate and oxygen saturation will be recorded 1 minute before the procedure during the procedure and 1 and 2 minutes after the procedure
Premature Infant Pain Profile PIPP Appendix 4 Stevens et al Premature Baby Pain Scale Premature by 1996 baby Pain Profile - PIPP has been developed Stevens et al 1996 found the Cronbach alpha value to be 071 for all items of the PIPP Apaydın Cırık 2019 Turkish validity and reliability study was conducted by Akcan and Yiğit 2015 In the study conducted by Akcan and Yiğit on preterm newborns between 26-36 weeks and 0-28 days old the PIPP score was 40 150 and 70 before during and after invasive intervention They found consistency between PIPP elements to be between 068 and 078 and homogeneity to be between 048 and 095 Akcan and Yiğit 2015
In order to evaluate the babys pain the PIPP scale questions 7 items such as gestational age behavioral status highest heart rate value lowest oxygen saturation value forehead wrinkling squinting of the eyes and widening of the nose wings Each item It is scored as 0 1 2 and 3 from best to worst According to the Premature Baby Pain Profile the babys pain is evaluated based on the total score Accordingly the highest is 21 points and the lowest is 0 points If the Premature Baby Pain Profile is between 0 and 6 points the pain is considered mild between 7 and 12 points it is considered moderate and between 13 and 21 points the pain is considered severe
Preterm recorded with a camera device The behavioral responses of newborns at the 1st minute before the procedure during the procedure and at the 1st and 2nd minute after the procedure will be evaluated with PIPP
Tools and equipment to be used in the study Camera Pulse Oximeter Device Oxygen Saturation Probe Injector Knitted Octopus
Knitted octopus The material must be washable and sterilizable so that the octopus can share the same space with the babies in the incubator octopus parts such as eyes and mouth should be sewn not plastic Knitted octopuses must be crocheted from cotton yarns 100 cotton 84 or 88 cotton acrylic washable at 60C and must be hypoallergenic fiber-filled 30 mm or 35 mm in size and protected from accidents To avoid this it is recommended that the tentacles Junior Coelho 2020 be 20 to 22 centimeters long and consist of 8 tentacles with a head of 8 to 10 centimeters Siqueira 2019 In line with this data it is planned to knit 3 octopuses initially and use them alternately after appropriate cleaning methods
Ethical Dimension Ethical approval for the conduct of the research was received from Pamukkale University Non-Interventional Clinical Research Ethics Committee 10012024 Decision number E-60116787-020-474228 Institutional permission was obtained from Pamukkale University Hospital for the intensive care unit where the study will be conducted
Analysis Data will be analyzed with the SPSS 250 IBM SPSS Statistics 25 software Armonk NY IBM Corp package programContinuous variables will be given as mean standard deviation and categorical variables will be given as number and percentage In examining the differences between groups the significance test of the difference between two means and one-way analysis of variance will be used when parametric test assumptions are met and Mann Whitney U test and Kruskal Wallis Analysis of Variance will be used when parametric test assumptions are not met Differences between categorical variables will be examined with Chi square analysis p 005 will be considered statistically significant
Hypothesis
This study aims to investigate the effect of breast milk and knitted octopus on pain caused by orogastric tube insertion in premature newborns
However there is no study in the literature comparing breast milk and the octopus knitting method together Considering that orogastric tube application in newborns is a common clinical practice it is important to minimize the side effects of this treatment method and increase the comfort of babies After the completion of the study it is thought that breast milk and knitted octopus will reduce the pain during orogastric tube insertion and can be used as a common practice in the clinic
Touch is considered the most basic communication and is well developed Breast milk increases immunity and ensures growth and developmentThe sense of taste is highly developed even in premature babies
There is no study in the literature comparing breast milk and the knitting octopus method togetherConsidering that orogastric tube application in newborns is a common clinical practice it is important to minimize the side effects of this treatment method and increase the comfort of babies
Aim of the study This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm neonates
Materials and Methods
Type of Research The research will be conducted as a randomized controlled study
Location Characteristics and Time Where the Research Was Conducted The study will be conducted between March 2024 and March 2026 in preterm neonates who received an orogastric tube in the neonatal intensive care unit of a university hospital in a province in the western region of Turkey In the hospital where the study was conducted there are level 3 level 2 and maternal adaptation room in the neonatal intensive care unit Approximately 31 nurses and 2 specialist doctors work in the neonatal intensive care unit
Population and Sample of the Study The study population will consist of newborns who received treatment and care in the Neonatal Intensive Care Unit of a university hospital in a province in the western region of Turkey between March 2024 and March 2026 and who meet the case selection criteria
The study sample will consist of preterm newborns with a gestational age of 32-34 weeks treated in the Neonatal Intensive Care Unit of the same hospital Infants fed with orogastric catheter in the neonatal intensive care unit will be included in the sample The effect size obtained in the reference study was found to be strong F0695 Şener Taplak and Erdem 2017 Assuming that a lower effect size F04 could be obtained as a result of the power analysis performed for 3 groups it was calculated that 80 power could be obtained at 95 confidence level when at least 66 infants at least 22 infants for each group were included in the study
Randomization Randomization in the research will be provided by the sealed envelope method In the case of an infant meeting the sampling criteria after obtaining signed informed consent from the parent the researcher will give the newborn a letter placed in a sealed envelope and the newborns will be randomly assigned to groups Which letter will represent which group will be determined at the beginning of the study using the closed opaque envelope method Accordingly letter C will be used for the control group letter B for the knitted octopus group and letter A for the breast milk group
Blinding Single blinding participants will be used in the study Participants will not be informed about which group they are in
Research Inclusion Criteria
Gestational week between 32-34 weeks
Postnatal age 37 weeks
Having breast milk
Weighing 1000 grams or more
Spontaneous breathing
Being fed with an orogastric tube
Not being exposed to a painful procedure at least half an hour before the interventions
Parental consent for the newborn to participate in the study
Criteria for Exclusion from the Study
Having received ventilator support may have received it before
Any congenital anomaly of the face or oral cavity
Grade 3 and 4 intraventricular hemorrhage
Taking opioid or non-opioid analgesics
Repeated orogastric tube placement
Application
After the parents accept the study and complete the Informed Consent Form the Preterm Newborn Introduction Form will be completedPain level will be evaluated by interpreting the camera image in accordance with the physiologic parameters measurement form and Premature Infant Pain Profile
Orogastric tube application is applied in neonatal intensive care unit to babies who cannot take by mouthOrogastric tubes can be changed daily or during the day according to the needs of the newborn
Since the pain level of breast milk knitted octopus and control group will be recorded with a camera during the orogastric catheter insertion procedure the procedure will be performed only once
Breast Milk Group Preterm newborns in this group will be administered their own mothers milk with a sterile syringe as 1 ml single dose 2 minutes before orogastric tube insertion During administration the baby will not be allowed to suck the tip of the syringe and breast milk will be dripped onto the tongue Nothing oral will be given 30 minutes before the procedure Preterm newborn will be monitored by camera recording for 5 minutes before during and 5 minutes after the procedure
Knitted Octopus Group The knitted octopus method will be applied to preterm newborns in this group before orogastric tube insertion The arms of the knitted octopus will wrap around the babys arms and legs and its head will be on the babys body The preterm newborn will be monitored by camera recording for 5 minutes before the procedure and for 5 minutes during and after the procedure
Control Group For preterm newborns in this group no method will be applied before orogastric tube insertion and routine procedures will be performed The preterm will be monitored for 5 minutes before birth during the procedure cycle and then by camera recording for 5 minutes
Data Collection Tools
Informed Consent Form Annex 1 It will include information such as the purpose of the research that participation is voluntary and that personal information will be kept confidential
Preterm Newborn Introduction Form Annex 2 The form prepared by the researcher will include the group in which the newborn is included mode of delivery 1st and 5th minute apgar score birth weight gender gestational age postnatal age and duration of orogastric catheter insertion
Physiological Parameters Measurement Form Annex 3 This form prepared by the researcher will help evaluate the pain heart rate and oxygen saturation value while the orogastric tube is inserted This form is preterm It was created to record the babys heart rate and oxygen saturation value During orogastric tube insertion heart rate and oxygen saturation will be recorded 1 minute before the procedure during the procedure and 1 and 2 minutes after the procedure
Premature Infant Pain Profile PIPP Appendix 4 Stevens et al Premature Baby Pain Scale Premature by 1996 baby Pain Profile - PIPP has been developed Stevens et al 1996 found the Cronbach alpha value to be 071 for all items of the PIPP Apaydın Cırık 2019 Turkish validity and reliability study was conducted by Akcan and Yiğit 2015 In the study conducted by Akcan and Yiğit on preterm newborns between 26-36 weeks and 0-28 days old the PIPP score was 40 150 and 70 before during and after invasive intervention They found consistency between PIPP elements to be between 068 and 078 and homogeneity to be between 048 and 095 Akcan and Yiğit 2015
In order to evaluate the babys pain the PIPP scale questions 7 items such as gestational age behavioral status highest heart rate value lowest oxygen saturation value forehead wrinkling squinting of the eyes and widening of the nose wings Each item It is scored as 0 1 2 and 3 from best to worst According to the Premature Baby Pain Profile the babys pain is evaluated based on the total score Accordingly the highest is 21 points and the lowest is 0 points If the Premature Baby Pain Profile is between 0 and 6 points the pain is considered mild between 7 and 12 points it is considered moderate and between 13 and 21 points the pain is considered severe
Preterm recorded with a camera device The behavioral responses of newborns at the 1st minute before the procedure during the procedure and at the 1st and 2nd minute after the procedure will be evaluated with PIPP
Tools and equipment to be used in the study Camera Pulse Oximeter Device Oxygen Saturation Probe Injector Knitted Octopus
Knitted octopus The material must be washable and sterilizable so that the octopus can share the same space with the babies in the incubator octopus parts such as eyes and mouth should be sewn not plastic Knitted octopuses must be crocheted from cotton yarns 100 cotton 84 or 88 cotton acrylic washable at 60C and must be hypoallergenic fiber-filled 30 mm or 35 mm in size and protected from accidents To avoid this it is recommended that the tentacles Junior Coelho 2020 be 20 to 22 centimeters long and consist of 8 tentacles with a head of 8 to 10 centimeters Siqueira 2019 In line with this data it is planned to knit 3 octopuses initially and use them alternately after appropriate cleaning methods
Ethical Dimension Ethical approval for the conduct of the research was received from Pamukkale University Non-Interventional Clinical Research Ethics Committee 10012024 Decision number E-60116787-020-474228 Institutional permission was obtained from Pamukkale University Hospital for the intensive care unit where the study will be conducted
Analysis Data will be analyzed with the SPSS 250 IBM SPSS Statistics 25 software Armonk NY IBM Corp package programContinuous variables will be given as mean standard deviation and categorical variables will be given as number and percentage In examining the differences between groups the significance test of the difference between two means and one-way analysis of variance will be used when parametric test assumptions are met and Mann Whitney U test and Kruskal Wallis Analysis of Variance will be used when parametric test assumptions are not met Differences between categorical variables will be examined with Chi square analysis p 005 will be considered statistically significant
Hypothesis
This study aims to investigate the effect of breast milk and knitted octopus on pain caused by orogastric tube insertion in premature newborns
However there is no study in the literature comparing breast milk and the octopus knitting method together Considering that orogastric tube application in newborns is a common clinical practice it is important to minimize the side effects of this treatment method and increase the comfort of babies After the completion of the study it is thought that breast milk and knitted octopus will reduce the pain during orogastric tube insertion and can be used as a common practice in the clinic
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