Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05538039
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2022-09-08
Brief Title:
Reducing Anxiety of Children and Their Parents in the Pre-elective Surgery Process
Sponsor:
Isparta University of Applied Sciences
Organization:
Isparta University of Applied Sciences
Study Overview
Official Title:
Comparison of the Effectiveness of Two Different Distraction Interventions in Reducing Preoperative Anxiety of Children and Parents Who Are Scheduled for Elective Surgery A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced According to previous studies one way to reduce child and parent anxiety in the preoperative process is distraction interventions the child and family with preoperative family-centered activities Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety This study was planned to Comparison of the effectiveness of two different distraction interventions distraction with play dough- distraction with kaleidoscope in reducing preoperative anxiety of children and parents who are scheduled for elective surgery
Detailed Description:
Aim This study was planned to Comparison of the effectiveness of two different distraction interventions distraction with play dough- distraction with kaleidoscope in reducing preoperative anxiety of children and parents who are scheduled for elective surgery
Method This study was planned as a randomized controlled trial The sample of the study will consist of 105 children aged 5-12 who will be operated on at Akdeniz University Hospital and their parents Randomization result It was planned to include a total of 105 children and their parents in 3 groups distraction with play dough group intervention group 1 35 distraction with kaleidoscope group intervention group 2 35 and control group 35 children and parents
Child and parent information form will be used to collect data Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample and Spielberger State Anxiety Scale will be used to collect data in parent sample
Intervention and Data Collection Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent Immediately after the pre-test first measurement is given to the children assigned to intervention group 1 and their parents attempts to distract attention with play dough will be applied for 10 minutes If they wish the child and parents will be told that they can continue to play with the play dough until premedication Children assigned to intervention group 2 and their parents will be distracted with a kaleidoscope for 10 minutes immediately after the pre-test first measurement is done If they wish the child and parents will be told that they can continue to play with the kaleidoscope until premedication Participants randomized to the control group will be given routine standard nursing care The second measurement will be administered 15 minutes after the interventions before premedicationpost test and the control group 25 minutes after the first measurement before premedicationposttest Thus the effectiveness of the initiatives and their comparison with each other will be evaluated
The data of the research will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The process of evaluating the data will be carried out with the support of a statistician
Method This study was planned as a randomized controlled trial The sample of the study will consist of 105 children aged 5-12 who will be operated on at Akdeniz University Hospital and their parents Randomization result It was planned to include a total of 105 children and their parents in 3 groups distraction with play dough group intervention group 1 35 distraction with kaleidoscope group intervention group 2 35 and control group 35 children and parents
Child and parent information form will be used to collect data Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample and Spielberger State Anxiety Scale will be used to collect data in parent sample
Intervention and Data Collection Randomization will be performed after the purpose of the study is explained to the child and parent who agreed to participate in the study and after obtaining consent Immediately after the pre-test first measurement is given to the children assigned to intervention group 1 and their parents attempts to distract attention with play dough will be applied for 10 minutes If they wish the child and parents will be told that they can continue to play with the play dough until premedication Children assigned to intervention group 2 and their parents will be distracted with a kaleidoscope for 10 minutes immediately after the pre-test first measurement is done If they wish the child and parents will be told that they can continue to play with the kaleidoscope until premedication Participants randomized to the control group will be given routine standard nursing care The second measurement will be administered 15 minutes after the interventions before premedicationpost test and the control group 25 minutes after the first measurement before premedicationposttest Thus the effectiveness of the initiatives and their comparison with each other will be evaluated
The data of the research will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The process of evaluating the data will be carried out with the support of a statistician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None