Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
Study NCT ID:
NCT06608550
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2024-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre-procedure Short Movie Video Training on the Child's Fear, Anxiety and Satisfaction
Sponsor:
Tarsus University
Organization:
Study Overview
Official Title:
The Effect of Pre-procedure Short Movie Video Training on the Child's Fear, Anxiety and Satisfaction Level in Children Undergoing Endoscopy Procedure
Status:
RECRUITING
Status Verified Date:
2025-05
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 was planned as a randomized controlled experimental study to examine the effect of short film video training before the endoscopy procedure on the child's fear, anxiety and satisfaction level in children who will undergo endoscopy procedure. The study will be conducted with children aged 9-12 years who applied to Mersin University Hospital Pediatric Gastroenterology Outpatient Clinic for endoscopy procedure. After obtaining written informed consent from the parents of the child who will undergo endoscopy, what will be done before the endoscopy procedure will be explained to the parent. Then a descriptive information form will be filled. Physiologic parameters (pulse, blood pressure, respiration, SPO2) will be measured before and after the procedure. The parent, nurse and the child themselves will evaluate the fear and anxiety score before and after the procedure, the satisfaction level will be determined by the child himself/herself and recorded on the follow-up form.
Detailed Description:
For the child, the process of illness and hospitalization and the unknowns are the main cause of fear. In order to minimize children's fears, the procedures to be performed, the hospital environment should be introduced and the family should be informed about the process. Since the child's fear will also affect the family, involving the family in all processes enables the child and family to manage the current situation well. In the endoscopy procedure, in addition to the fear and anxiety caused by the procedure, opening an IV line before the procedure, not recognizing the environment where the procedure will be performed, being separated from the parents, not having information about the procedure, and receiving sedation are among the factors that will cause stress. For this reason, informing about the procedure, introducing the environment where the procedure will be performed, informing about the procedures before and during the procedure will ensure that this process is well managed and thus reduce fear and anxiety. Considering that fear and anxiety negatively affect the surgical procedure process, the rate of complications in the postoperative period of the child increases and the hospital stay is prolonged accordingly. It was planned as a randomized controlled experimental study to examine the effect of short film video training before the endoscopy procedure on the child's fear, anxiety and satisfaction level in children who will undergo endoscopy procedure.
The population of the study, which is planned as a randomized controlled experimental type study, will consist of children aged 9-12 years who apply to the pediatric gastroenterology outpatient clinic of Mersin University Hospital and will undergo endoscopy procedure. It was calculated that a total of 84 children, at least 41 in each group, should be included in the study with an effect size = 0.735, 95% confidence interval, and 95% power. Considering the possibility of drop outs and confounding variables in the research process, the number in the groups was increased by 10%. The sample of the study was determined as 90 children in total, 45 children in each group.
Randomization: In the study, 90 children in the sample will be randomly assigned to the control and short film viewing groups. Random assignment will be ensured by using a computer program to determine the group of 90 children in the sample.The data of the study will be collected using the following data collection tools:Introductory Information Form,Child Fear Scale,State Anxiety Scale for Children,Child Satisfaction Scale.
The population of the study, which is planned as a randomized controlled experimental type study, will consist of children aged 9-12 years who apply to the pediatric gastroenterology outpatient clinic of Mersin University Hospital and will undergo endoscopy procedure. It was calculated that a total of 84 children, at least 41 in each group, should be included in the study with an effect size = 0.735, 95% confidence interval, and 95% power. Considering the possibility of drop outs and confounding variables in the research process, the number in the groups was increased by 10%. The sample of the study was determined as 90 children in total, 45 children in each group.
Randomization: In the study, 90 children in the sample will be randomly assigned to the control and short film viewing groups. Random assignment will be ensured by using a computer program to determine the group of 90 children in the sample.The data of the study will be collected using the following data collection tools:Introductory Information Form,Child Fear Scale,State Anxiety Scale for Children,Child Satisfaction Scale.
Study Oversight
Has Oversight DMC:
False
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?: