Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646848
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Effects of Vibration Heel Warming and Shotblocker on Pain Levels During Heel Blood Collection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Vibration Heel Warming and Shotblocker on Pain Levels During Heel Blood Collection A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Vibration Heel Warming and Shotblocker on pain levels during heel blood collection on healthy term newborns
Detailed Description:
Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn Practices such as reducing environmental stimuli individualized developmental care music therapy breast milk pacifier giving sucrose non-nutritive sucking oral sucrose kangaroo care facilitated tucking position and sweet solutions massage and touching positioning nesting kangaroo care fetal positioning are included
This study is a prospective randomized and controlled trial In this study aim the effect of Vibration Heel Warming and Shotblocker during heel blood collection on the pain levels in healthy term newborns will be examined
Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method
Newborns were divided into four groups Vibration group n50 Heel Warming group n50 Shotblocker group n50 and Control group n50
Data were collected using the Infant-family Information Form and NIPS - Neonatal Infant Pain Scale Data collection All blood sampling was performed in a quiet nursery room between 0900 AM and 1100 AM 1-2 hours after breastfeeding the normal time when infants undergo heel stick for routine blood collection for metabolic screening Blood collection was performed in a standardized manner by the same nurse who has a minimum of 5 years experience in the performance heel stick and had no conflict of interest A pediatrician made the clinical decision for heel stick
Before the procedure the newborns were kept in a quiet room far away from the cries of other babies The infants diapers were changed before procedure For the heel stick procedure the antiseptic solution 70 alcohol heel stick method heel region for sampling the outer right side of the ball needle 21-G needle and environmental factors such as heat light and noise were all standardized The whole procedure was video-recorded until three minutes after the procedure
At the beginning of the study the parents of the newborns were informed about the aim and content of the research and parental approval was obtained Neonatal and family demographics were collected using self-report information forms which included medical history mothers gestational age neonatal age sex birth weight duration of sampling total crying time processing time and the time from the start of the first cry to the first crying during the process
All blood sampling in the study was performed for clinical purposes such as newborn metabolic screening tests which were taken on the second to third days following birth The standard protocol for blood sampling involved swabbing the heel with a small gauze pad with disinfectant lancing the heel and then gently squeezing the heel intermittently until the amount of blood required for clinical use was collected
All procedures performed in the experimental and control groups were video recorded by the researcher from the beginning of the procedure After the procedure the newborns pain levels and crying duration were evaluated using the video recordings Assessment of pain was conducted independently by the investigator and the nurse using NIPS At the same time the newborns total procedural crying time the duration of the procedure and the first calming time were recorded The total crying time of the newborns was measured from the start of crying due to heel stick to the complete cessation of crying The time of the procedure was measured from the beginning to the end of the heel stick procedure The calming time was measured from the time of the first cry to the first calming time
This study is a prospective randomized and controlled trial In this study aim the effect of Vibration Heel Warming and Shotblocker during heel blood collection on the pain levels in healthy term newborns will be examined
Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method
Newborns were divided into four groups Vibration group n50 Heel Warming group n50 Shotblocker group n50 and Control group n50
Data were collected using the Infant-family Information Form and NIPS - Neonatal Infant Pain Scale Data collection All blood sampling was performed in a quiet nursery room between 0900 AM and 1100 AM 1-2 hours after breastfeeding the normal time when infants undergo heel stick for routine blood collection for metabolic screening Blood collection was performed in a standardized manner by the same nurse who has a minimum of 5 years experience in the performance heel stick and had no conflict of interest A pediatrician made the clinical decision for heel stick
Before the procedure the newborns were kept in a quiet room far away from the cries of other babies The infants diapers were changed before procedure For the heel stick procedure the antiseptic solution 70 alcohol heel stick method heel region for sampling the outer right side of the ball needle 21-G needle and environmental factors such as heat light and noise were all standardized The whole procedure was video-recorded until three minutes after the procedure
At the beginning of the study the parents of the newborns were informed about the aim and content of the research and parental approval was obtained Neonatal and family demographics were collected using self-report information forms which included medical history mothers gestational age neonatal age sex birth weight duration of sampling total crying time processing time and the time from the start of the first cry to the first crying during the process
All blood sampling in the study was performed for clinical purposes such as newborn metabolic screening tests which were taken on the second to third days following birth The standard protocol for blood sampling involved swabbing the heel with a small gauze pad with disinfectant lancing the heel and then gently squeezing the heel intermittently until the amount of blood required for clinical use was collected
All procedures performed in the experimental and control groups were video recorded by the researcher from the beginning of the procedure After the procedure the newborns pain levels and crying duration were evaluated using the video recordings Assessment of pain was conducted independently by the investigator and the nurse using NIPS At the same time the newborns total procedural crying time the duration of the procedure and the first calming time were recorded The total crying time of the newborns was measured from the start of crying due to heel stick to the complete cessation of crying The time of the procedure was measured from the beginning to the end of the heel stick procedure The calming time was measured from the time of the first cry to the first calming time
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