The Effect Of Interactive Robot on Children's After The Surgery

Pediatric Surgery Clinical Trial

Official title:

The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05185830
• Other study ID #: 2020.17
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 1, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Surgery

Intervention

Other:
• Interactive robots
Children will mobilize with the interactive robot when control group will mobilize with nurse.

Locations

Country	Name	City	State
Turkey	Remziye Semerci	Edirne	Center

Sponsors (2)

Lead Sponsor	Collaborator
Trakya University	Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety assessment by the Child Anxiety Scale-State Anxiety	The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.	Baseline (Before the mobilization)
Primary	Parental Satisfaction assessment by Parental Satisfaction Scoring-Visual Analog Scale	Parental Satisfaction Score-Visual Analog Scale is scored as "0-not satisfied at all", "10-very satisfied". It will be used to evaluate the satisfaction of the parents of the children in the whole group towards post-operative nursing care.	After the postop children's mobilization up to 6 hours
Primary	Mobilization duration assessment by the Mobilization Chart	The mobilization schedule created by the researchers ensures that the time the child was mobilized on the first and second days after the surgery and the standing/walking time during each mobilization were recorded. The chart will be filled by the nurses. A stopwatch will be used to calculate the standing time. The stand-up period will start with the child getting up from the bed and will end when he/she goes back to bed.	walking time at the child's first mobilization up to 6 hours
Primary	Mobilization frequency assessment by the Mobilization Chart	The mobilization schedule created by the researchers ensures that the time the child was mobilized on the first and second days after the surgery and the standing/walking time during each mobilization were recorded. The chart will be filled by the nurses. A stopwatch will be used to calculate the standing time. The stand-up period will start with the child getting up from the bed and will end when he/she goes back to bed.	through study completion, an average of 6 hours