PainNCT05462964
Reducing Pain During Orogastric Tube Insertion in Newborns: Use of Pacifiers and Pacifiers Sweetened With 25% Dextrose
A study testing Pacifiers Group (İntervention Group 1) and Pacifier group sweetened with 25% dextrose (İntervention Group 2) in people with Pain, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 38 to 42 weeks
- Conditions the study is for
- Pain
- What is being tested?
- Pacifiers Group (İntervention Group 1) and Pacifier group sweetened with 25% dextrose (İntervention Group 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2018to 18 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies are term newborns with 38-42 weeks of gestation,
- Having a newborn for whom only OGT insertion will be attempted,
- Having a newborn who did not receive any painful stimuli until 30 minutes before the intervention,
- The parent's volunteering for the newborn to participate in the study formed the inclusion criteria.
Who cannot join
- Newborns with any congenital anomalies of the face or oral cavity,
- Newborns with 3rd and 4th degree intraventricular hemorrhage,
- Newborns receiving muscle relaxants, analgesics, and sedation formed the exclusion criteria of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Use of Pacifier and Pacifier With Dextrose on Reducing Pain During Orogastric Tube Insertion in Newborns: A Randomized Controlled Trial
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.
Read the detailed description
Painful and invasive procedures for follow-up, diagnostic and therapeutic purposes are an inevitable part of care in the neonatal intensive care unit. Effective pain management is at the core of nursing care and is based on a comprehensive assessment of the infant and its pain. Nurses and the interdisciplinary healthcare team have a responsibility to prevent or minimize pain during these procedures. Studies to reduce pain during OGT insertion were generally performed in premature newborns, but there are few studies performed in term newborns. It has been observed that there are not enough studies on OGT that focus on NGT placement in the studies. In the studies examined, the use of dextrose and pacifier alone, which are non-pharmacological methods in reducing pain, were generally discussed, and no studies involving the combined use were found. It is thought that our study will be useful in terms of the fact that feeding tube placement, which is known to be a painful and stressful procedure, will be performed in term newborns, presenting new evidence to nurses for reducing pain and stress, and supporting the existing study results.
This study is a randomized controlled experimental study to examine the effect of using pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement in newborns, as well as to evaluate behavioral responses and physiological changes 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. Ethical approval was obtained from the Bursa Uludağ University Faculty of Medicine Clinical Research Ethics Committee before starting the study. In order to start the research after the approval of the ethics committee, T.C. Permissions were obtained from the Istanbul Provincial Health Directorate and the Istanbul Tuzla State Hospital management. In addition, written consent was obtained from the families of the newborns in the control and intervention groups, with an informed consent form. The research was carried out in Turkey/Istanbul Tuzla State Hospital neonatal intensive care unit between April-December 2019. The population consisted of term newborns who were hospitalized in the neonatal intensive care unit of Istanbul Tuzla State Hospital, whose OGT placement procedure was deemed clinically appropriate, and legal permission was obtained from their families. Of these newborns, a total of 60 newborns, 20+20 in the intervention group and 20 in the control group, were included in the sample group. The first intervention group consisted of 20 newborns given a pacifier alone, the second intervention group consisted of 20 newborns given a pacifier sweetened with 25% dextrose, and 20 newborns in the control group. Randomization was provided by the researcher for babies who met the inclusion criteria of the study during weekday neonatal intensive care unit working hours. For this; During working hours, the first newborn to be fitted with OGT was in the control group, the second newborn was given a pacifier only, and the third newborn was in the pacifier intervention group sweetened with 25% dextrose. When there was not enough OGT indication (less than 3) on the same day, the application continued in the same order in the next clinical shift. It was applied in the same way for each group before the procedure. Information about the baby and the mother in the baby and mother introduction form, which was prepared by using the literature, was filled in before the procedure. The newborns were placed under a radiant warmer in an open bed 5 minutes before the procedure. In newborns who could not be placed under a radiant heater, the application was performed in an incubator. After the preparation of the necessary materials before the application, the OGT measurement to be placed was made and the marking process was carried out. A saturation probe was placed in the baby to monitor heart rate and oxygen saturation. The newborn was prepared for the procedure by adjusting the camera monitor focused on the baby's face in the field of view. 2 minutes before OGT insertion, 20 babies in the intervention groups were given pacifiers alone, and 20 babies were given pacifiers sweetened with 25% dextrose. The procedure was carried out by leaking the tube from the pacifiers. In the control group, routine OGT placement was performed without giving anything. The data collection process was recorded with a camera. After the evaluation period was completed and the baby was comfortable, the recording was stopped. However, the recording continued without any time constraint to monitor the crying time of the baby who continued to cry during the insertion. The dependent variables of the study were the score from the NIPS pain scale, oxygen saturation, heart rate, and crying time.
- Conditions
- Pain
- Being tested
- Pacifiers Group (İntervention Group 1), Pacifier group sweetened with 25% dextrose (İntervention Group 2)
- Keywords
- Neonatal, Orogastric tube, Pacifiers, %25 Dextrose, NIPS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacifiers Group (İntervention Group 1)Behavioural
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.
Pacifier group sweetened with 25% dextrose (İntervention Group 2)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Newborns in this group were started to camera recording 2 minutes before the procedure and routine OGT placement was performed. 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.After OGT insertion, a light touch was provided if necessary to ensure routine comfort of the baby for ethical reasons. |
| İntervention Group 1 | Experimental | Only a pacifier was given to the newborn. Receives: Behavioral: Pacifiers Group (İntervention Group 1) |
| İntervention Group 2 | Experimental | The newborn was given a pacifier sweetened with 25% dextrose. Receives: Behavioral: Pacifier group sweetened with 25% dextrose (İntervention Group 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
Measured: Pre-procedure
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
Measured: During the procedure
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
Measured: 1st minute after OGT placement.
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
Measured: 3rd minute after OGT placement.
Secondary outcomes (7)
Highest Heart Rate
Nellcor Bedside Console Type Pulse Oximeter Device was used to monitor heart rate. The recording was made by adjusting the camera focused on the baby's face to show the pulse oximeter device within the field of view. Highest heart rate was evaluated from camera recordings within 15 seconds before OGT insertion, during the procedure, and at 3 minutes after insertion.
Measured: Within 15 seconds before OGT insertion
Highest Heart Rate
Nellcor Bedside Console Type Pulse Oximeter Device was used to monitor heart rate. The recording was made by adjusting the camera focused on the baby's face to show the pulse oximeter device within the field of view. Highest heart rate was evaluated from camera recordings within 15 seconds before OGT insertion, during the procedure, and at 3 minutes after insertion.
Measured: During the procedure
Highest Heart Rate
Nellcor Bedside Console Type Pulse Oximeter Device was used to monitor heart rate. The recording was made by adjusting the camera focused on the baby's face to show the pulse oximeter device within the field of view. Highest heart rate was evaluated from camera recordings within 15 seconds before OGT insertion, during the procedure, and at 3 minutes after insertion.
Measured: 3 minutes after insertion
Lowest Oxygen Saturation
Nellcor Bedside Console Type Pulse Oximeter Device was used to monitor heart rate. The recording was made by adjusting the camera focused on the baby's face to show the pulse oximeter device within the field of view. The lowest oxygen saturation was evaluated from camera recordings within 15 seconds before OGT insertion, during the procedure, and at 3 minutes after insertion.
Measured: Within 15 seconds before OGT insertion
Lowest Oxygen Saturation
Nellcor Bedside Console Type Pulse Oximeter Device was used to monitor heart rate. The recording was made by adjusting the camera focused on the baby's face to show the pulse oximeter device within the field of view. The lowest oxygen saturation was evaluated from camera recordings within 15 seconds before OGT insertion, during the procedure, and at 3 minutes after insertion.
Measured: During the procedure
Lowest Oxygen Saturation
Nellcor Bedside Console Type Pulse Oximeter Device was used to monitor heart rate. The recording was made by adjusting the camera focused on the baby's face to show the pulse oximeter device within the field of view. The lowest oxygen saturation was evaluated from camera recordings within 15 seconds before OGT insertion, during the procedure, and at 3 minutes after insertion.
Measured: 3 minutes after insertion
Crying Time
Focusing on the baby's face, the camera also records sound. During the procedure, the recording continued without time constraint to monitor the crying time of the baby. The crying time during the procedure was evaluated by listening to the camera recording audibly.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start25 Dec 2018
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Akkaya Gul, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462964
- Sponsor's protocol ID
- UludagUniversity-AKKAYAGUL
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akkaya-Gul A, Ozyazicioglu N. Effect of pacifier and pacifier with dextrose in reducing pain during orogastric tube insertion in newborns: a randomized controlled trial. J Perinatol. 2024 May;44(5):717-723. doi: 10.1038/s41372-024-01948-w. Epub 2024 Mar 29.
PubMed 38553602
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of Pacifier and Pacifier With Dextrose on Reducing Pain During Orogastric Tube Insertion in Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05462964
- Acronym / sponsor ID
- UludagUniversity-AKKAYAGUL
- Conditions
- Pain
- Keywords
- Neonatal, Orogastric tube, Pacifiers, %25 Dextrose, NIPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Painful and invasive procedures for follow-up, diagnostic and therapeutic purposes are an inevitable part of care in the neonatal intensive care unit. Effective pain management is at the core of nursing care and is based on a comprehensive assessment of the infant and its pain. Nurses and the interdisciplinary healthcare team have a responsibility to prevent or minimize pain during these procedures. Studies to reduce pain during OGT insertion were generally performed in premature newborns, but there are few studies performed in term newborns. It has been observed that there are not enough studies on OGT that focus on NGT placement in the studies. In the studies examined, the use of dextrose and pacifier alone, which are non-pharmacological methods in reducing pain, were generally discussed, and no studies involving the combined use were found. It is thought that our study will be useful in terms of the fact that feeding tube placement, which is known to be a painful and stressful procedure, will be performed in term newborns, presenting new evidence to nurses for reducing pain and stress, and supporting the existing study results.
This study is a randomized controlled experimental study to examine the effect of using pacifiers and dextrose pacifiers on pain reduction during orogastric tube placement in newborns, as well as to evaluate behavioral responses and physiological changes 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. Ethical approval was obtained from the Bursa Uludağ University Faculty of Medicine Clinical Research Ethics Committee before starting the study. In order to start the research after the approval of the ethics committee, T.C. Permissions were obtained from the Istanbul Provincial Health Directorate and the Istanbul Tuzla State Hospital management. In addition, written consent was obtained from the families of the newborns in the control and intervention groups, with an informed consent form. The research was carried out in Turkey/Istanbul Tuzla State Hospital neonatal intensive care unit between April-December 2019. The population consisted of term newborns who were hospitalized in the neonatal intensive care unit of Istanbul Tuzla State Hospital, whose OGT placement procedure was deemed clinically appropriate, and legal permission was obtained from their families. Of these newborns, a total of 60 newborns, 20+20 in the intervention group and 20 in the control group, were included in the sample group. The first intervention group consisted of 20 newborns given a pacifier alone, the second intervention group consisted of 20 newborns given a pacifier sweetened with 25% dextrose, and 20 newborns in the control group. Randomization was provided by the researcher for babies who met the inclusion criteria of the study during weekday neonatal intensive care unit working hours. For this; During working hours, the first newborn to be fitted with OGT was in the control group, the second newborn was given a pacifier only, and the third newborn was in the pacifier intervention group sweetened with 25% dextrose. When there was not enough OGT indication (less than 3) on the same day, the application continued in the same order in the next clinical shift. It was applied in the same way for each group before the procedure. Information about the baby and the mother in the baby and mother introduction form, which was prepared by using the literature, was filled in before the procedure. The newborns were placed under a radiant warmer in an open bed 5 minutes before the procedure. In newborns who could not be placed under a radiant heater, the application was performed in an incubator. After the preparation of the necessary materials before the application, the OGT measurement to be placed was made and the marking process was carried out. A saturation probe was placed in the baby to monitor heart rate and oxygen saturation. The newborn was prepared for the procedure by adjusting the camera monitor focused on the baby's face in the field of view. 2 minutes before OGT insertion, 20 babies in the intervention groups were given pacifiers alone, and 20 babies were given pacifiers sweetened with 25% dextrose. The procedure was carried out by leaking the tube from the pacifiers. In the control group, routine OGT placement was performed without giving anything. The data collection process was recorded with a camera. After the evaluation period was completed and the baby was comfortable, the recording was stopped. However, the recording continued without any time constraint to monitor the crying time of the baby who continued to cry during the insertion. The dependent variables of the study were the score from the NIPS pain scale, oxygen saturation, heart rate, and crying time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Newborns in this group were started to camera recording 2 minutes before the procedure and routine OGT placement was performed. 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.After OGT insertion, a light touch was provided if necessary to ensure routine comfort of the baby for ethical reasons. |
| İntervention Group 1 | Experimental | Behavioral: Pacifiers Group (İntervention Group 1)Only a pacifier was given to the newborn. |
| İntervention Group 2 | Experimental | Behavioral: Pacifier group sweetened with 25% dextrose (İntervention Group 2)The newborn was given a pacifier sweetened with 25% dextrose. |
Who may qualify
- Ages
- 38 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Babies are term newborns with 38-42 weeks of gestation,
- Having a newborn for whom only OGT insertion will be attempted,
- Having a newborn who did not receive any painful stimuli until 30 minutes before the intervention,
- The parent's volunteering for the newborn to participate in the study formed the inclusion criteria.
Key exclusion criteria (3 listed)
- Newborns with any congenital anomalies of the face or oral cavity,
- Newborns with 3rd and 4th degree intraventricular hemorrhage,
- Newborns receiving muscle relaxants, analgesics, and sedation formed the exclusion criteria of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | İntervention Group 1 |
| 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. | Behavioural | İntervention Group 2 |
Primary outcome
Neonatal Infant Pain Scale (NIPS)
Time frame: Pre-procedure
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
Neonatal Infant Pain Scale (NIPS)
Time frame: During the procedure
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
Neonatal Infant Pain Scale (NIPS)
Time frame: 1st minute after OGT placement.
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
Neonatal Infant Pain Scale (NIPS)
Time frame: 3rd minute after OGT placement.
The Neonatal Infant Pain Scale (NIPS) scale was used for pain assessment.The primary outcome was the pain score assessed with NIPS scale, a validated and widely used tool to measure procedural pain in infants. NIPS is a measurement tool that includes five behavioral groupings (facial expression, crying, movements of arms and legs, state of alertness) and one physiological parameter (respiration pattern). Of the indicators, only crying is scored between 0 and 2, while the other indicators are scored as 0 or 1. Evaluation results in a possible total score between 0 and 7. A high score indicates an increase in the severity of pain.NIPS pain assessment: pre-procedure, during the procedure, 1st minute and 3rd minute after OGT placement.
7 secondary outcomes
Highest Heart Rate
Time frame: Within 15 seconds before OGT insertion
Highest Heart Rate
Time frame: During the procedure
Highest Heart Rate
Time frame: 3 minutes after insertion
Lowest Oxygen Saturation
Time frame: Within 15 seconds before OGT insertion
Lowest Oxygen Saturation
Time frame: During the procedure
Lowest Oxygen Saturation
Time frame: 3 minutes after insertion
Crying Time
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Derived from this study: PubMed 38553602Akkaya-Gul A, Ozyazicioglu N. Effect of pacifier and pacifier with dextrose in reducing pain during orogastric tube insertion in newborns: a randomized controlled trial. J Perinatol. 2024 May;44(5):717-723. doi: 10.1038/s41372-024-01948-w. Epub 2024 Mar 29.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacifiers Group (İntervention Group 1) and Pacifier group sweetened with 25% dextrose (İntervention Group 2) in people with Pain, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale (NIPS) (time frame: Pre-procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.