Pediatric Surgery Clinical Trial
Official title:
The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery
NCT number | NCT05185830 |
Other study ID # | 2020.17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 29, 2021 |
Est. completion date | June 1, 2022 |
Verified date | October 2022 |
Source | Trakya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Remziye Semerci | Edirne | Center |
Lead Sponsor | Collaborator |
---|---|
Trakya University | Koç University |
Turkey,
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 |
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