The Effect Of Interactive Robot on Children's After The Surgery

October 19, 2022 updated by: Sacide Yildizeli Topcu, Trakya University

The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery

This project will be conducted with 5-10-year-old children who will undergo an outpatient surgery in Trakya University Health Research and Application Center at Pediatric Surgery Clinic and their parents. It is reported in the literature that technology-based applications and robot use are promising innovations in reducing pain, anxiety, and fear in children. This was the main starting point in the planning of the study. In this study, by using interactive robot, it was aimed to reduce postoperative mobilization anxiety, to increase frequency / duration of the mobilization and to increase parental satisfaction of the children undergoing outpatient surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of interactive robots is expected to reduce the child's anxiety by ensuring that the child is physically, psychologically, and socially optimal. It is foreseen that the child with reduced anxiety will be willing to mobilize with the interactive robot and it will increase the mobilization time and the frequency of the mobilization during the day. Decreasing the anxiety of children and increasing the desire for mobilization will increase the satisfaction of the families.

The study will be conducted with 84 children (42 Experiment + 42 Control) aged 5-10 years. The study was planned as a randomized controlled study. Data will be collected by "Questionnaire Form" and "Child Anxiety Scale-State Anxiety" and Parental Satisfaction Scoring-Visual Analog Scale" and "Mobilization Chart". Families will be informed about the research and before the surgery, families, and children in both groups will be informed about the benefits of mobilization. Two hours after the operation, just before the mobilization, the children in the experimental group will be introduced to the robot, and the children in the control group will be asked to mobilize with their parents.

When the child is first mobilized at the time recommended by the physician for all groups after the surgery, the child's anxiety for mobilization will be assessed using the Child Anxiety Scale (State Anxiety). The mobilization time of the children will be measured by stopwatch and recorded in the Mobilization Schedule together with the frequency of mobilization. Parental Satisfaction Scale- Visual Analogue Scale will be applied to evaluate the satisfaction of the parents towards the application.

Study Type

Interventional

Enrollment (Actual)

84

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
    • Center
      • Edirne, Center, Turkey, 22030
        • Remziye Semerci

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

5 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergo day surgery,
  • Speaking Turkish,
  • Being a volunteer to participate in the study,
  • Being 5-10 aged,
  • Do not have a visual, auditory, or mental problem and their parents will be included in the research.

Exclusion Criteria:

  • No undergo day surgery,
  • No Speaking Turkish,
  • Not being a volunteer to participate in the study,
  • Not being 5-10 aged,
  • Have a visual, auditory, or mental problem and their parents will be included in the research.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interactive robot
Children in the interactive robot will be mobilized for the first time with interactive robots.
Other: Interactive robots
Children will mobilize with the interactive robot when control group will mobilize with nurse.
NO_INTERVENTION: Control group
Children in the control group will be mobilized with nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety assessment by the Child Anxiety Scale-State Anxiety
Time Frame: Baseline (Before the mobilization)
The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.
Baseline (Before the mobilization)
Parental Satisfaction assessment by Parental Satisfaction Scoring-Visual Analog Scale
Time Frame: After the postop children's mobilization up to 6 hours
Parental Satisfaction Score-Visual Analog Scale is scored as "0-not satisfied at all", "10-very satisfied". It will be used to evaluate the satisfaction of the parents of the children in the whole group towards post-operative nursing care.
After the postop children's mobilization up to 6 hours
Mobilization duration assessment by the Mobilization Chart
Time Frame: walking time at the child's first mobilization up to 6 hours
The mobilization schedule created by the researchers ensures that the time the child was mobilized on the first and second days after the surgery and the standing/walking time during each mobilization were recorded. The chart will be filled by the nurses. A stopwatch will be used to calculate the standing time. The stand-up period will start with the child getting up from the bed and will end when he/she goes back to bed.
walking time at the child's first mobilization up to 6 hours
Mobilization frequency assessment by the Mobilization Chart
Time Frame: through study completion, an average of 6 hours
The mobilization schedule created by the researchers ensures that the time the child was mobilized on the first and second days after the surgery and the standing/walking time during each mobilization were recorded. The chart will be filled by the nurses. A stopwatch will be used to calculate the standing time. The stand-up period will start with the child getting up from the bed and will end when he/she goes back to bed.
through study completion, an average of 6 hours

Collaborators and Investigators

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

Sponsor

Trakya University

Collaborators

Koç University

Investigators

  • Principal Investigator: Sacide Yildizeli Topcu, PhD, Trakya 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)

January 29, 2021

Primary Completion (ACTUAL)

May 30, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 10, 2022

First Posted (ACTUAL)

January 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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