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

Sponsor
Trakya University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05185830
Collaborator
Koç University (Other)
84
1
2
18
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interactive robots
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Non-Randomized study with control groupNon-Randomized study with control group
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery
Actual Study Start Date :
Jan 29, 2021
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interactive robot

Children in the interactive robot will be mobilized for the first time with interactive robots.

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

No Intervention: Control group

Children in the control group will be mobilized with nurses

Outcome Measures

Primary Outcome Measures

  1. Anxiety assessment by the Child Anxiety Scale-State Anxiety [Baseline (Before the mobilization)]

    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.

  2. Parental Satisfaction assessment by Parental Satisfaction Scoring-Visual Analog Scale [After the postop children's mobilization up to 6 hours]

    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.

  3. Mobilization duration assessment by the Mobilization Chart [walking time at the child's first mobilization up to 6 hours]

    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.

  4. Mobilization frequency assessment by the Mobilization Chart [through study completion, an average of 6 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Remziye Semerci Edirne Center Turkey 22030

Sponsors and Collaborators

  • Trakya University
  • Koç University

Investigators

  • Principal Investigator: Sacide YILDIZELİ TOPÇU, PhD, Trakya University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sacide Yildizeli Topcu, Assistant Professor, Trakya University
ClinicalTrials.gov Identifier:
NCT05185830
Other Study ID Numbers:
  • 2020.17
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sacide Yildizeli Topcu, Assistant Professor, Trakya University

Study Results

No Results Posted as of Jan 11, 2022