Interactive Robot on Pre-operative Anxiety and Fear of Children

November 20, 2023 updated by: Tuba Arpacı, Karamanoğlu Mehmetbey University

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

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of interactive robots can be preferred as a remarkable method of communication with hospitalized children. In this way, it will be easier for the children to understand the procedure and they will be able to communicate easily with healthcare professionals. Children may develop a sense of control and the level of anxiety and fear they experience may decrease when they interact with robots. It is reported in the literature that children show more interest in robots than they do in adults. In addition, children see social robots as living creatures, not as devices, and children who spend time with them for a long time adopt them as friends. In a study, a social humanoid robot was used to prepare children aged 7-12 (n = 11) regarding the cancer diagnosis process and interventional procedures. According to the results of the study, the children's stress, depression, and anger during the treatment decreased significantly. Interactive robots positively affect postoperative mobilization in children undergoing day surgery and reduce the anxiety level of children before mobilization. As a result, it may be easier for children to cope with stress with the use of interactive and humanoid robots. Also, interactive robots can facilitate cooperation between the child and the nurse by playing an intermediary role in communication with children. Determining the effects of interactive robots on children by using them before the surgical procedure is important to ensure the active participation of children in the surgical process in pediatric surgery clinics. It is thought that this research is important in terms of interventions which appropriate to the supportive care role of nurses and will contribute to the literature.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Karaman, Turkey, 70200
        • Karaman education and research hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.
Other: interactive robot group
Intervention group will receive one day pre-operative preparation intervention applied by researcher. Preparation will be 30-40 minutes long

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: one day
Children's State Anxiety Scale: Validated scale used for evaluation of 4-10 aged children's anxiety level. Scale score ranges between 0-10.
one day
Fear
Time Frame: one day
Children's Fear Scale: Validated scale used for evaluation of 5-10 aged children's fear level. Scale score ranges between 0-4.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karamanoğlu Mehmetbey University

Investigators

  • Principal Investigator: Tuba ARPACI, PhD, Karamanoglu Mehmetbey University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

November 18, 2023

Study Completion (Actual)

November 18, 2023

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KMU-SBF-TA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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