Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600763
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Ice Pack and Lukewarm Gel Pad Use on Pain Anxiety Level and Physiological Parameters
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Ice Pack and Lukewarm Gel Pad Use on Pain Anxiety Level and Physiological Parameters of the Child During Surgical Drain Removal in Children Aged 9-18 Years
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:
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain anxiety level and physiological parameters of children aged 9-18 years
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist Mostly acute abdomen intra-abdominal mass excision hypospadias surgery and congenital megacolon surgeries are performed
The clinic provides outpatient and emergency services on a 247 basis Data Collection In the study children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study
Application
1 Phase The necessary ethics committee and institutional permission will be obtained before starting the study
2 Stage The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician
3 Stage After obtaining written informed consent from the childamp39s parents for the drain removal procedure the researcher will explain the drain removal procedure and what will be done during the procedure to the parents Then the descriptive information form will be filled
4 Stage Physiological parameters pulse blood pressure respiration SPO2 of the children will be measured by the researcher before and after the procedure
5 Before the procedure the necessary materials ice pack or warm gel ice infrared thermometer gloves saline scalpel clamp sterile sponge plaster and scissors will be prepared and the drainage system will be clamped
6 The parent and nurse will assess and record the childamp39s pain score 15 minutes before during and 15 minutes after the procedure The child will be asked to make the same assessments and the results will be recorded
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist Mostly acute abdomen intra-abdominal mass excision hypospadias surgery and congenital megacolon surgeries are performed
The clinic provides outpatient and emergency services on a 247 basis Data Collection In the study children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study
Application
1 Phase The necessary ethics committee and institutional permission will be obtained before starting the study
2 Stage The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician
3 Stage After obtaining written informed consent from the childamp39s parents for the drain removal procedure the researcher will explain the drain removal procedure and what will be done during the procedure to the parents Then the descriptive information form will be filled
4 Stage Physiological parameters pulse blood pressure respiration SPO2 of the children will be measured by the researcher before and after the procedure
5 Before the procedure the necessary materials ice pack or warm gel ice infrared thermometer gloves saline scalpel clamp sterile sponge plaster and scissors will be prepared and the drainage system will be clamped
6 The parent and nurse will assess and record the childamp39s pain score 15 minutes before during and 15 minutes after the procedure The child will be asked to make the same assessments and the results will be recorded
Detailed Description:
Non-pharmacologic methods can be used to reduce pain during drain removal One of these methods is cold application Cold application shows a local anesthetic effect in the application area by increasing the release of endogenous opioids by stimulating touch receptors based on the gate control theory and the pain felt is reduced as a result of these mechanisms
It is thought that ice pack and warm gel ice applications to be used during drain removal in pediatric patients may be a non-pharmacologic method for surgical drain removal and will contribute to comprehensive research on this subject
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain anxiety level and physiological parameters of children aged 9-18 years
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist Mostly acute abdomen intra-abdominal mass excision hypospadias surgery and congenital megacolon surgeries are performed
The clinic provides outpatient and emergency services on a 247 basis Data Collection In the study children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study
Application
1 Phase The necessary ethics committee and institutional permission will be obtained before starting the study
2 Stage The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician
3 Stage After obtaining written informed consent from the childamp39s parents for the drain removal procedure the researcher will explain the drain removal procedure and what will be done during the procedure to the parents Then the descriptive information form will be filled
4 Stage Physiological parameters pulse blood pressure respiration SPO2 of the children will be measured by the researcher before and after the procedure
5 Before the procedure the necessary materials ice pack or warm gel ice infrared thermometer gloves saline scalpel clamp sterile sponge plaster and scissors will be prepared and the drainage system will be clamped
6 The parent and nurse will assess and record the child pain score 15 minutes before during and 15 minutes after the procedure The child will be asked to make the same assessments and the results will be recorded
Ice pack application group An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication The temperature of the area where the ice pack is applied will be measured at one minute intervals and when the relevant area reaches a temperature of 136 0C the physician will be informed and the drain removal procedure will be initiated The child will be asked to mark the degree of pain felt before during and after the procedure
Warm gel pad application group Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end in a sheath designed to wrap around the drain After waiting for 10 minutes in the application area the drainage system will be removed by the physician
Control group The integrated drainage system will be withdrawn by the physician The child will not receive any non-pharmacologic intervention before during or after the procedure
It is thought that ice pack and warm gel ice applications to be used during drain removal in pediatric patients may be a non-pharmacologic method for surgical drain removal and will contribute to comprehensive research on this subject
The study was planned as a randomized controlled experimental study to determine the effect of cold application used during surgical drain removal on pain anxiety level and physiological parameters of children aged 9-18 years
The study will be conducted between July 2024 and April 2025 in the Pediatric Surgery Service of Adana City Training and Research Hospital Pediatric Surgery Service has a capacity of 24 beds and 14 nurses work on a roster basis with 5 nurses during the day and 3 nurses at night The clinical physician staff consists of 8 pediatric surgery specialists and 1 pediatric urologist Mostly acute abdomen intra-abdominal mass excision hypospadias surgery and congenital megacolon surgeries are performed
The clinic provides outpatient and emergency services on a 247 basis Data Collection In the study children treated in pediatric surgery and followed up with drainage system after abdominal surgery will be evaluated in terms of sampling criteria and children who do not meet the criteria will be excluded from the study
Application
1 Phase The necessary ethics committee and institutional permission will be obtained before starting the study
2 Stage The decision to remove the drainage system after the end of function or end of indication is communicated to the investigator by the physician
3 Stage After obtaining written informed consent from the childamp39s parents for the drain removal procedure the researcher will explain the drain removal procedure and what will be done during the procedure to the parents Then the descriptive information form will be filled
4 Stage Physiological parameters pulse blood pressure respiration SPO2 of the children will be measured by the researcher before and after the procedure
5 Before the procedure the necessary materials ice pack or warm gel ice infrared thermometer gloves saline scalpel clamp sterile sponge plaster and scissors will be prepared and the drainage system will be clamped
6 The parent and nurse will assess and record the child pain score 15 minutes before during and 15 minutes after the procedure The child will be asked to make the same assessments and the results will be recorded
Ice pack application group An ice pack kept in the refrigerator and having a temperature of -10 degrees Celsius will be wrapped in sterile gauze and applied to the drain area of the pediatric patient who is decided to end the surgical drain indication The temperature of the area where the ice pack is applied will be measured at one minute intervals and when the relevant area reaches a temperature of 136 0C the physician will be informed and the drain removal procedure will be initiated The child will be asked to mark the degree of pain felt before during and after the procedure
Warm gel pad application group Gel pads kept at room temperature will be applied to the drain area of the pediatric patient whose surgical drain indication is decided to end in a sheath designed to wrap around the drain After waiting for 10 minutes in the application area the drainage system will be removed by the physician
Control group The integrated drainage system will be withdrawn by the physician The child will not receive any non-pharmacologic intervention before during or after the procedure
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