Pediatric SurgeryNCT05185830
The Effect Of Interactive Robot on Children's After The Surgery
A study testing Interactive robots in people with Pediatric Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Surgery
- What is being tested?
- Interactive robots
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery
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.
Read the 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.
- Conditions
- Pediatric Surgery
- Being tested
- Interactive robots
- Keywords
- interactive robot, child, surgery, mobilization, anxiety, parental satisfaction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive robotsOther
Children will mobilize with the interactive robot when control group will mobilize with nurse.
| Study group | Role | What they receive |
|---|---|---|
| Interactive robot | Experimental | Children in the interactive robot will be mobilized for the first time with interactive robots. Receives: Other: Interactive robots |
| Control group | No intervention | Children in the control group will be mobilized with nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Before the mobilization)
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.
Measured: After the postop children's mobilization up to 6 hours
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.
Measured: walking time at the child's first mobilization up to 6 hours
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.
Measured: through study completion, an average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start29 Jan 2021
- Primary completion30 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-Randomized study with control group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, Sacide Yildizeli Topcu, Trakya University
- Investigators
- Sacide YILDIZELİ TOPÇU, PhD, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185830
- Sponsor's protocol ID
- 2020.17
- Status last verified
- Oct 2022
- First submitted
- 21 Dec 2021
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery
- ClinicalTrials.gov ID
- NCT05185830
- Acronym / sponsor ID
- 2020.17
- Conditions
- Pediatric Surgery
- Keywords
- interactive robot, child, surgery, mobilization, anxiety, parental satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-Randomized study with control group
| Arm | Type | Receives |
|---|---|---|
| Interactive robot | Experimental | Other: Interactive robotsChildren in the interactive robot will be mobilized for the first time with interactive robots. |
| Control group | No intervention | –Children in the control group will be mobilized with nurses |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive robotsChildren will mobilize with the interactive robot when control group will mobilize with nurse. | Other | Interactive robot |
Primary outcome
Anxiety assessment by the Child Anxiety Scale-State Anxiety
Time frame: 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.
Parental Satisfaction assessment by Parental Satisfaction Scoring-Visual Analog Scale
Time frame: 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.
Mobilization duration assessment by the Mobilization Chart
Time frame: 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.
Mobilization frequency assessment by the Mobilization Chart
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sacide YILDIZELİ TOPÇU, PhD principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive robots in people with Pediatric Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety assessment by the Child Anxiety Scale-State Anxiety (time frame: Baseline (Before the mobilization)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.