Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611085
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Cold Application Vibration and Vibrating Ice on Pain Fear and Satisfaction Level in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Cold Application Vibration and Vibrating Ice on Pain Fear and Satisfaction Level in Children Aged 7-12 Years Who Underwent Blood Glucose Level Measurement
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:
The aim of this study was to determine the effects of cold application vibration and vibrating ice on pain fear and satisfaction levels in children aged 7-12 years who underwent blood glucose level measurementThe population of the study will consist of children aged 7-12 years who receive treatment and care in the pediatric ward of the Ministry of Health University of Health Sciences Izmir Tepecik Training and Research Hospital between July 2024 and July 2025 Descriptive Information Form Child Fear Scale Numerical Pain Scale and Child Satisfaction Scale will be used to collect the research data
Detailed Description:
Pain and painful experiences make the child more vulnerable to pain Since it is not possible to eliminate the feeling of pain in pediatric patients effective pain management has an important place This study aimed to determine the effects of cold application vibration and vibrating ice on pain fear and satisfaction levels in children aged 7-12 years who underwent blood glucose level measurementThe population of the study will consist of children aged 7-12 years who receive treatment and care in the pediatric ward of the Ministry of Health University of Health Sciences Izmir Tepecik Training and Research Hospital between July 2024 and July 2025 Collection of Research Data The study will be started after ethics committee approval and written institutional authorisation
Data will be collected before blood glucose measurement according to the clinical routine and the time of blood glucose measurement of the child In the collection of data pediatric patients admitted to the paediatric ward and their parents who meet the inclusion criteria of the study and agree to participate in the study will be informed about the purpose of the study and the study and their verbal and written permissions will be obtained
Data collection forms Descriptive Information Form Fear Scale will be applied to the children and parents in the sample group Fear assessment of the child will be done by the child nurse and parent
The hand to be used for intervention will be determined by lottery Cards labelled right and left will be prepared and the child will be asked to draw from the envelope in a closed manner
After determining the hands for intervention and control measurements will be made according to the clinical routine for the first control In clinical routine practice in the measurement of blood glucose level a puncture is performed with a lancet pen then the first blood is wiped off and the second blood is measured with a glucometer
Intervention
The index finger of the child will be used in the cold application group In this group cold application will be performed by placing the index finger of the designated hand on a 10 x 10 cm ice pack for 30 seconds and then removing the ice pack immediately
In the vibration group the middle finger of the child will be used In this group vibration was applied by targeting the tip of the middle finger area using a vibrator device measuring 2x1x3 cm The insertion of the needle will coincide with the application of the vibration stimulation
In the vibration and ice group cold and vibration stimulation will be applied to the child simultaneously The ring finger of the designated hand was placed on a 10x10 cm ice pack for 30 seconds and subjected to cold application Simultaneously vibration stimulation will be applied to the tip of the middle finger area using a vibrator device with dimensions of 3x1 cm and 2x1 cm After 30 seconds the ice bag will be removed and the lancet pen will be adjusted for drilling from the fingertip while vibration stimulation continues
After blood glucose measurement Fear Scale Numerical Pain Scale and Child Satisfaction Scale will be applied after each non-pharmacological intervention Fear and pain assessment of children will be done by the child nurse and parent
Data will be collected before blood glucose measurement according to the clinical routine and the time of blood glucose measurement of the child In the collection of data pediatric patients admitted to the paediatric ward and their parents who meet the inclusion criteria of the study and agree to participate in the study will be informed about the purpose of the study and the study and their verbal and written permissions will be obtained
Data collection forms Descriptive Information Form Fear Scale will be applied to the children and parents in the sample group Fear assessment of the child will be done by the child nurse and parent
The hand to be used for intervention will be determined by lottery Cards labelled right and left will be prepared and the child will be asked to draw from the envelope in a closed manner
After determining the hands for intervention and control measurements will be made according to the clinical routine for the first control In clinical routine practice in the measurement of blood glucose level a puncture is performed with a lancet pen then the first blood is wiped off and the second blood is measured with a glucometer
Intervention
The index finger of the child will be used in the cold application group In this group cold application will be performed by placing the index finger of the designated hand on a 10 x 10 cm ice pack for 30 seconds and then removing the ice pack immediately
In the vibration group the middle finger of the child will be used In this group vibration was applied by targeting the tip of the middle finger area using a vibrator device measuring 2x1x3 cm The insertion of the needle will coincide with the application of the vibration stimulation
In the vibration and ice group cold and vibration stimulation will be applied to the child simultaneously The ring finger of the designated hand was placed on a 10x10 cm ice pack for 30 seconds and subjected to cold application Simultaneously vibration stimulation will be applied to the tip of the middle finger area using a vibrator device with dimensions of 3x1 cm and 2x1 cm After 30 seconds the ice bag will be removed and the lancet pen will be adjusted for drilling from the fingertip while vibration stimulation continues
After blood glucose measurement Fear Scale Numerical Pain Scale and Child Satisfaction Scale will be applied after each non-pharmacological intervention Fear and pain assessment of children will be done by the child nurse and parent
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