- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568197
Effect of Video- Assisted Preoperative Education on Fear, Anxiety, and Pain in Children Undergoing Tonsil Surgery
The Effect of Video-Assisted Preoperative Education on Fear, Anxiety, and Pain Levels in Children Undergoing Tonsillectomy: A Randomized Controlled Study
This study aims to evaluate the effect of video-assisted preoperative education on fear, anxiety, and postoperative pain in childern undergoing tonsil surgery. Preoperative anxiety and fear are common among pediatric patients and may negatively affect postoperative outcomes. providing structured and age-appropriate information through video-based education may help reduce these negative emotional responses.
ın this study, children scheduled for tonsil surgery will receive video-assisted preoperative education, and their levels of fear, anxiety, and pain wiil be assessed using standardized measurement tools. the results of this study are expected to contribute to improving preoperative preparation and postoperative outcomes in pediatric patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- VKV Amerikan Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Childern aged 4-10 years
- Scheduled for tonsil surgery
- living with both parents
- undergoing surgery for the first time
- Able to count from 1 to 10
Exclusion Criteria:
- children with delayed or impaired language development
- children with visual or hearing impairments that prevent completion of the assessmenttools
- children with a disgnosed psychiatric disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video-Assisted Education Group
Children receive video-assisted preoperative education before tonsil surgery in addition to routine care
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A structured video-based educational program provided to children before tonsil surgery.
The intervention aims to reduce fear and anxiety in the postoperative period, with outcomes assessed both before and after surgery.
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No Intervention: Control Group
Children receive routine preoperative care without video-assisted education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preopertive and Postoperative Fear, Anxiety, and Pain Levels
Time Frame: Baseline (1 day before surgery); immediately after the pre-anesthesia interview; orning of surger; 1 hour after surgery
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Baseline (1 day before surgery); immediately after the pre-anesthesia interview; orning of surger; 1 hour after surgery
|
|
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Fear, Anxiety, and Pain Levels
Time Frame: preoperative period and postoperative period (from before surgery to after surgery)
|
Fear, anxiety, and pain levels in children undergoing tonsil surgery are assesed using validated scales in the preoperative and postoperative periods.
|
preoperative period and postoperative period (from before surgery to after surgery)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TONSİL-VİDEO-TR-2023.220.IRBI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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