Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628232
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Effect of Nursing Interventions on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Giving a Pacifier Dipped in Breast Milk Heel Warming and Applying Both Together on Pain and Salivary Cortisol Levels During Heel Stick in Preterm Newborns Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Babies born before the thirty-seventh gestational week are called preterm or premature Most preterm newborns require Neonatal Intensive Care Unit NICU care depending on their gestational age and clinical condition Although many painful invasive procedures are usually performed on newborns in the NICU the most common procedure is heel prick Heel prick is a painful and stressful procedure for the newborn Neonates do not respond to pain verbally they respond physiologically behaviorally and hormonally Physiologic responses of preterm infants to pain include increased heart and respiratory rate increased blood pressure and intracranial pressure decreased oxygenation and sweating of palms Among the hormonal symptoms caused by stress in newborns the most commonly used biochemical method is the measurement of cortisol level It is reported that there is a significant correlation between salivary and plasma cortisol levels and salivary cortisol level reflects plasma cortisol level This method is particularly preferred because saliva sampling is much less stressful
Detailed Description:
Health professionals should be able to evaluate pain reduce or eliminate pain in pain management of neonates in interventional applications Pharmacologic and nonpharmacologic methods are used in pain management When these methods are applied together their effectiveness increases in pain related to invasive interventions Pharmacologically opioid analgesics sedatives and local anesthetics are used Nonpharmacologic methods include breastfeeding pacifier oral sucrose music warm application massage therapeutic touch and positioning such as nesting fetal positioning swaddling kangaroo care rocking and holding
In many studies nonpharmacologic interventions have been applied and compared to reduce pain during heel prick in preterm newborns In the routine of the clinic heel prick blood collection from preterm newborns is performed by hugging the mother in her lap The swaddling procedure for preterm newborns in the control group is recommended by the American Academy of Pediatrics The swaddling method supports flexion and lateral posture which is the developmental position of the newborn With this position the newborn comes to its position in the uterus which is familiar to it ensuring its physiological stability and improving its capacity In a systematic review of 3396 participants preterm newborns were calmed and immediately stabilized by kangaroo care non-nutritive sucking and swaddling methods Since these methods reduce pain and stress in preterm newborns they are also reported to be included in Individualized Supportive Developmental Care practices
Many studies have shown that giving pacifiers to newborns is effective in reducing pain In addition oral administration of breast milk alone without breastfeeding has been found to reduce pain during heel prick nasopharyngeal aspiration venipuncture and retinopathy examination in preterms In the study conducted by Lan et al breast milk was sniffed to the newborn during heel prick blood collection or tasted by dropping into the newborns mouth with a syringe As a result they reported that sniffing and plus tasting breast milk was effective in alleviating pain in newborns
In the literature it is emphasized that the pain that occurs during heel blood collection is closely related to the squeezing of the heel to collect blood not during the needle insertion into the heel and it is thought that keeping the newborn in an upright position during heel blood collection may facilitate blood flow through gravity and reduce the amount of squeezing required to obtain the sample However there are studies showing that heel warming is effective in reducing pain in newborns It has been stated that with warm application to the heel -with the effect of vasodilation- fewer needling is performed in the heel the amount of blood required for the procedure increases and the procedure is completed in a shorter time It is predicted that the heel of the newborn will be squeezed less thanks to the warm application
However there is a very limited number of studies evaluating the effectiveness of different nonpharmacologic interventions during heel prick blood collection and measuring the stress marker cortisol In addition no study was found to investigate the effectiveness of other interventions heel warming and giving a pacifier dipped in breast milk in combination with wrapping among nonpharmacological interventions
This study aimed to reduce pain during heel prick blood collection in preterm newborns by swaddling the baby in the mothers lap control group swaddling in the mothers lap together with giving a pacifier dipped in breast milk pacifier with breast milk group swaddling in the mothers lap together with local dry heat application heel heating group and all interventions combined swaddling in the mothers lap together with giving a pacifier dipped in breast milk and heel heating-combined intervention group In addition it was planned as a randomized controlled experimental design to determine and compare the effects of these nursing interventions on the newborns physiological parameters pain salivary cortisol level crying and procedure time
Place and Time to Conduct the Research
The research will be carried out between November 2024 and August 2025 in the Neonatal Intensive Care Unit of Tekirdag Namik Kemal University Hospital
Population and Sample of the Study
The study population will consist of infants who meet the inclusion criteria in the NICU of Tekirdağ Namik Kemal University between 01112024-01082025
The sample size of the study was determined by power analysis The study comparing non-nutritive suction sucrose and combination interventions in heel prick blood collection in newborns with the control group was taken as a basis According to the PIPP pain assessment scale used in the study the 1st experimental group had a mean score of 93 13 the 2nd experimental group 101 2 the 3rd group 44 15 and the control group 133 16 In this study it was determined that a total of 88 infants 22 in each group should be included in the study in the sample number calculation made in the GPower 3192 program with a 5 alpha margin of error two-way and 80 power predicting that the PIPP score mean difference would have a large effect size 95 large effect the effect size was found to be 274
Randomization
The sample will be randomly selected from the study population In the study randomization of premature newborns will be performed in a computer environment The newborns to be subjected to heel prick blood collection were placed in groups with a randomized controlled method with 18 babies in each group In the study randomization was performed by entering the number of cases through the program whose URL address is httpwwwrandomizerorg
Control swaddling from mothers lap 76 41 70 15 43 38 63 2 28 55 30 35 86 61 57 84 80 74 3 24 83 71 Experiment 2 swaddling from mothers lap pacifier 18 79 23 19 48 47 2 61 10 73 35 74 87 38 32 5 11 12 49 80 44 55 Experiment 3 swaddling from mothers lap heel warming 25 17 50 7 64 35 45 11 48 82 73 23 32 54 49 74 79 3 68 56 24 81 Experiment 4 swaddling from mothers lap pacifier heel warming 57 33 21 64 13 47 56 31 41 28 43 85 20 1 75 52 11 14 3 6 38 15
In many studies nonpharmacologic interventions have been applied and compared to reduce pain during heel prick in preterm newborns In the routine of the clinic heel prick blood collection from preterm newborns is performed by hugging the mother in her lap The swaddling procedure for preterm newborns in the control group is recommended by the American Academy of Pediatrics The swaddling method supports flexion and lateral posture which is the developmental position of the newborn With this position the newborn comes to its position in the uterus which is familiar to it ensuring its physiological stability and improving its capacity In a systematic review of 3396 participants preterm newborns were calmed and immediately stabilized by kangaroo care non-nutritive sucking and swaddling methods Since these methods reduce pain and stress in preterm newborns they are also reported to be included in Individualized Supportive Developmental Care practices
Many studies have shown that giving pacifiers to newborns is effective in reducing pain In addition oral administration of breast milk alone without breastfeeding has been found to reduce pain during heel prick nasopharyngeal aspiration venipuncture and retinopathy examination in preterms In the study conducted by Lan et al breast milk was sniffed to the newborn during heel prick blood collection or tasted by dropping into the newborns mouth with a syringe As a result they reported that sniffing and plus tasting breast milk was effective in alleviating pain in newborns
In the literature it is emphasized that the pain that occurs during heel blood collection is closely related to the squeezing of the heel to collect blood not during the needle insertion into the heel and it is thought that keeping the newborn in an upright position during heel blood collection may facilitate blood flow through gravity and reduce the amount of squeezing required to obtain the sample However there are studies showing that heel warming is effective in reducing pain in newborns It has been stated that with warm application to the heel -with the effect of vasodilation- fewer needling is performed in the heel the amount of blood required for the procedure increases and the procedure is completed in a shorter time It is predicted that the heel of the newborn will be squeezed less thanks to the warm application
However there is a very limited number of studies evaluating the effectiveness of different nonpharmacologic interventions during heel prick blood collection and measuring the stress marker cortisol In addition no study was found to investigate the effectiveness of other interventions heel warming and giving a pacifier dipped in breast milk in combination with wrapping among nonpharmacological interventions
This study aimed to reduce pain during heel prick blood collection in preterm newborns by swaddling the baby in the mothers lap control group swaddling in the mothers lap together with giving a pacifier dipped in breast milk pacifier with breast milk group swaddling in the mothers lap together with local dry heat application heel heating group and all interventions combined swaddling in the mothers lap together with giving a pacifier dipped in breast milk and heel heating-combined intervention group In addition it was planned as a randomized controlled experimental design to determine and compare the effects of these nursing interventions on the newborns physiological parameters pain salivary cortisol level crying and procedure time
Place and Time to Conduct the Research
The research will be carried out between November 2024 and August 2025 in the Neonatal Intensive Care Unit of Tekirdag Namik Kemal University Hospital
Population and Sample of the Study
The study population will consist of infants who meet the inclusion criteria in the NICU of Tekirdağ Namik Kemal University between 01112024-01082025
The sample size of the study was determined by power analysis The study comparing non-nutritive suction sucrose and combination interventions in heel prick blood collection in newborns with the control group was taken as a basis According to the PIPP pain assessment scale used in the study the 1st experimental group had a mean score of 93 13 the 2nd experimental group 101 2 the 3rd group 44 15 and the control group 133 16 In this study it was determined that a total of 88 infants 22 in each group should be included in the study in the sample number calculation made in the GPower 3192 program with a 5 alpha margin of error two-way and 80 power predicting that the PIPP score mean difference would have a large effect size 95 large effect the effect size was found to be 274
Randomization
The sample will be randomly selected from the study population In the study randomization of premature newborns will be performed in a computer environment The newborns to be subjected to heel prick blood collection were placed in groups with a randomized controlled method with 18 babies in each group In the study randomization was performed by entering the number of cases through the program whose URL address is httpwwwrandomizerorg
Control swaddling from mothers lap 76 41 70 15 43 38 63 2 28 55 30 35 86 61 57 84 80 74 3 24 83 71 Experiment 2 swaddling from mothers lap pacifier 18 79 23 19 48 47 2 61 10 73 35 74 87 38 32 5 11 12 49 80 44 55 Experiment 3 swaddling from mothers lap heel warming 25 17 50 7 64 35 45 11 48 82 73 23 32 54 49 74 79 3 68 56 24 81 Experiment 4 swaddling from mothers lap pacifier heel warming 57 33 21 64 13 47 56 31 41 28 43 85 20 1 75 52 11 14 3 6 38 15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None