Animation, Cartoons, Preoperative Care, Anesthesia, PediatricNCT06382025
Preoperative Information With Storybook for Pediatric Anesthesia
A study testing showing cartoons -storybook and showing cartoons - standard in people with Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric
- What is being tested?
- showing cartoons -storybook and showing cartoons - standard
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2018to 29 May 2020
- 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
- Pediatric surgery patient including inguinal hernia repair, circumcision and tonsillectomy.
- without having previous emergency surgery and anesthetic experience,
Who cannot join
- Their parents reported developmental delays, mental retardation, or chronic illnesses of the children
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Storybook vs Standart Information on Anesthesia Anxiety in Preoperative Period in Pediatric Patients
Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period.
- Being tested
- showing cartoons -storybook, showing cartoons - standard
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
showing cartoons -storybookOther
A goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period
showing cartoons - standardOther
standard
| Study group | Role | What they receive |
|---|---|---|
| storybook | Active comparator | Not described Receives: Other: showing cartoons -storybook |
| standart | Placebo comparator | Not described Receives: Other: showing cartoons - standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative anxiety scale
Measured: baseline ( before induction of anesthesia)
State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents
Measured: baseline ( before induction of anesthesia)
Children's Hospital of Eastern Ontario Pain (CHEOP) Scale
Measured: Postoperative 0-24 hours
Pediatric Anesthesia Emergence Delirium (PAED) scale
Measured: Postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start9 Mar 2018
- Primary completion20 Feb 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Animation, Cartoons, Preoperative Care, Anesthesia, PediatricStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alkin Colak, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382025
- Sponsor's protocol ID
- Alkinstorybook
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Storybook vs Standart Information on Anesthesia Anxiety in Preoperative Period in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06382025
- Acronym / sponsor ID
- Alkinstorybook
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 24 Apr 2024 (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.
Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| storybook | Active comparator | Other: showing cartoons -storybook |
| standart | Placebo comparator | Other: showing cartoons - standard |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric surgery patient including inguinal hernia repair, circumcision and tonsillectomy.
- without having previous emergency surgery and anesthetic experience,
Key exclusion criteria (2 listed)
- Their parents reported developmental delays, mental retardation, or chronic illnesses of the children
- Emergency surgery
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 |
|---|---|---|
| showing cartoons -storybookA goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period | Other | storybook |
| showing cartoons - standardstandard | Other | standart |
Primary outcome
preoperative anxiety scale
Time frame: baseline ( before induction of anesthesia)
State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents
Time frame: baseline ( before induction of anesthesia)
Children's Hospital of Eastern Ontario Pain (CHEOP) Scale
Time frame: Postoperative 0-24 hours
Pediatric Anesthesia Emergence Delirium (PAED) scale
Time frame: Postoperative 1 hour
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 24 Apr 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing showing cartoons -storybook and showing cartoons - standard in people with Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric, 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 2 inclusion and 2 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 24 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
preoperative anxiety scale (time frame: baseline ( before induction of anesthesia)). 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 24 Apr 2024.