Clinical trial NCT05185830: The Effect Of Interactive Robot on Children's After The Surgery
Official title: The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Surgery
Keywords: interactive robot
child
surgery
mobilization
anxiety
parental satisfaction
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2022-01-11
Enrollment: 84
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-Randomized study with control group
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Anxiety assessment by the Child Anxiety Scale-State Anxiety
timeFrame: Baseline (Before the mobilization)
measure: Parental Satisfaction assessment by Parental Satisfaction Scoring-Visual Analog Scale
timeFrame: After the postop children's mobilization up to 6 hours
measure: Mobilization duration assessment by the Mobilization Chart
timeFrame: walking time at the child's first mobilization up to 6 hours
measure: Mobilization frequency assessment by the Mobilization Chart
timeFrame: through study completion, an average of 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Remziye Semerci
state: Center
Study officials:
affiliation: Trakya University
name: Sacide YILDIZELİ TOPÇU, PhD
role: PRINCIPAL_INVESTIGATOR
References: