Interactive Robot on Pre-operative Anxiety and Fear of Children

Sponsor
Karamanoğlu Mehmetbey University (Other)
Overall Status
Completed
CT.gov ID
NCT06148844
Collaborator
(none)
74
1
2
2
36.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: interactive robot group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two group with conventional therapy control groupTwo group with conventional therapy control group
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Control group will receive conventional pre-operative preparation and intervention group will receive pre-operative preparation designed with interactive robot by researchers
Primary Purpose:
Supportive Care
Official Title:
The Effect of Interactive Robot on Pre-operative Anxiety and Fear of Children
Actual Study Start Date :
Sep 18, 2023
Actual Primary Completion Date :
Nov 18, 2023
Actual Study Completion Date :
Nov 18, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Anxiety [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.

  2. Fear [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karaman Education and Research Hospital Karaman Turkey 70200

Sponsors and Collaborators

  • Karamanoğlu Mehmetbey University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tuba Arpacı, Asisstant Professor, Karamanoğlu Mehmetbey University
ClinicalTrials.gov Identifier:
NCT06148844
Other Study ID Numbers:
  • KMU-SBF-TA-01
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tuba Arpacı, Asisstant Professor, Karamanoğlu Mehmetbey University

Study Results

No Results Posted as of Nov 28, 2023