Clinical trial NCT06148844: Interactive Robot on Pre-operative Anxiety and Fear of Children
Official title: The Effect of Interactive Robot on Pre-operative Anxiety and Fear of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: minor surgical procedures
nursing
interactive robot
chlidren
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 74
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group with conventional therapy control group
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: one day
measure: Fear
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Education and Research Hospital
Study officials:
affiliation: Karamanoğlu Mehmetbey University
name: Tuba ARPACI, PhD
role: PRINCIPAL_INVESTIGATOR
References: