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

NCT ID: NCT05185830

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2022-06-01

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.

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.

Conditions

Pediatric Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interactive robot

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

Group Type: EXPERIMENTAL

Interactive robots

Intervention Type: OTHER

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

Control group

Children in the control group will be mobilized with nurses

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interactive robots

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Koç University

OTHER

Sponsor Role: collaborator

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Sacide Yildizeli Topcu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sacide YILDIZELİ TOPÇU, PhD

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

Remziye Semerci

Edirne, Center, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020.17

Identifier Type: -

Identifier Source: org_study_id