Interactive Robot on Pre-operative Anxiety and Fear of Children

Surgery Clinical Trial

Official title:

The Effect of Interactive Robot on Pre-operative Anxiety and Fear of Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06148844
• Other study ID #: KMU-SBF-TA-01
• Status: Completed
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: November 18, 2023

Study information

• Verified date: November 2023
• Source: Karamanoglu Mehmetbey University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 18, 2023
• Est. primary completion date: November 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
Turkey	Karaman Education and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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