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

NCT05185830 | Completed

• 1 other identifier: 2020.17
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Surgery

Keywords

interactive robot; child; surgery; mobilization; anxiety; parental satisfaction

Outcome Measures

Primary Outcomes (4)

• Anxiety assessment by the Child Anxiety Scale-State Anxiety

  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

  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

  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

  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

Study Arms (2)

Interactive robot

EXPERIMENTAL

Children in the interactive robot will be mobilized for the first time with interactive robots.

Other: Interactive robots

Control group

NO INTERVENTION

Children in the control group will be mobilized with nurses

Interventions

Interactive robots OTHER

Children will mobilize with the interactive robot when control group will mobilize with nurse.

Interactive robot

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead
• Koç University: collaborator

Study Sites (1)

Remziye Semerci

Edirne, Center, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sacide YILDIZELİ TOPÇU, PhD

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Non-Randomized study with control group

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: January 29, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 1, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)