Interactive Robot on Pre-operative Anxiety and Fear of Children

NCT06148844 | Completed

• 1 other identifier: KMU-SBF-TA-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgery

Keywords

minor surgical procedures; nursing; interactive robot; chlidren

Outcome Measures

Primary Outcomes (2)

• Anxiety

  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

  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

Study Arms (2)

Control Group

NO INTERVENTION

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.

Interactive robot group

EXPERIMENTAL

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

Interventions

interactive robot group OTHER

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

Interactive robot group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children have mental-cognitive problems,
• Children have hearing, vision and/or speech disabilities

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Karaman Education and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

Study Officials

• Tuba ARPACI, PhD

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Control group will receive conventional pre-operative preparation and intervention group will receive pre-operative preparation designed with interactive robot by researchers
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Model Details: Two group with conventional therapy control group

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: September 18, 2023
• Primary Completion: November 18, 2023
• Study Completion: November 18, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)