- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148844
Interactive Robot on Pre-operative Anxiety and Fear of Children
The Effect of Interactive Robot on Pre-operative Anxiety and Fear of Children
The aim of this study is to determine the effect of preoperative preparation applied with an interactive robot on children's preoperative anxiety and fear levels.
Hypothesis;
H1: Pre-operative preparation with an interactive robot has an effect on the anxiety level of children H2: Pre-operative preparation with an interactive robot has an effect on the fear level of children H3: The anxiety levels of children in intervention and control groups are different after the pre-operative preparation H4: The fear levels of children in intervention and control groups are different after the pre-operative preparation
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Karaman, Turkey, 70200
- Karaman education and research hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those between the ages of 5-10,
- having planned day surgery,
- scheduled for general anesthesia
- have not had surgery before,
- Those who can speak Turkish
Exclusion Criteria:
- Children have mental-cognitive problems,
- Children have hearing, vision and/or speech disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control Group
The routine preparation procedure in this group in the hospital will be applied by the nurses responsible for preoperative preparation.
After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels.
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Experimental: Interactive robot group
In addition to the routine preparation procedure interactive robot will be used to preparation as a therapeutic approach.
The interactive robot will accompany to the child the preparation for the surgery.
Then, the features of the interactive robot will be explained to the children and parents and it will be introduced to the children.
The interactive robot will meet the child with its speech feature and the robot will accompany to child to the operating room entrance.
The child will be informed that he/she can request the interactive robot to follow him/her if he/she wishes.
The child will be transferred to the operating room accompanied by the nurse, researcher and robot.
After pre-operative preparation, the child, parent and nurse will be asked to fill out the anxiety and fear scales to evaluate the child's anxiety and fear levels.
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Intervention group will receive one day pre-operative preparation intervention applied by researcher.
Preparation will be 30-40 minutes long
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety
Time Frame: one day
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Children's State Anxiety Scale: Validated scale used for evaluation of 4-10 aged children's anxiety level.
Scale score ranges between 0-10.
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one day
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Fear
Time Frame: one day
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Children's Fear Scale: Validated scale used for evaluation of 5-10 aged children's fear level.
Scale score ranges between 0-4.
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one day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tuba ARPACI, PhD, Karamanoğlu Mehmetbey University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- KMU-SBF-TA-01
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
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