Children Under General AnaesthesiaTABLETNCT03531359
Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial
A study testing TIBD and Midazolam in people with Children Under General Anaesthesia, run by Universidad de Valparaiso at 1 site in Chile.
Trial summary
Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Children Under General Anaesthesia
- What is being tested?
- TIBD and Midazolam
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChile
- Study dates
- 4 Jul 2018to 30 Jul 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.
Who cannot join
- Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Carlos Van Buren
Valparaíso, 2341131
Nathalie Lopez, M.D., 2364000, nathalielopez.jq@gmail.com
Anamaria Correa, M.D., correanamaria@gmail.com
About this study
Official title: Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial
Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.
Read the detailed description
It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.
For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.
There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.
- Conditions
- Children Under General Anaesthesia
- Being tested
- TIBD, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIBDDevice
Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.
MidazolamDrug
Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.
| Study group | Role | What they receive |
|---|---|---|
| TIBD Tablet-based video distraction | Experimental | Children will receive of tablet-based interctive games in preoperatory room Receives: Device: TIBD |
| Midazolam | Active comparator | Children will be premedicated with usual treatmente (midazolam) Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
Difference between the measurement of the mYPAS-SF applied in the preoperative time and prior to induction.
The scale has 18 items in 4 categories. Maximum score is 100 points. The higher the score, the greater the anxiety.
Measured: 6 hours
Secondary outcomes (4)
Cooperation with the induction
Scale with 10 items, 1 point for each one. 0 points shows an induction with perfect cooperation.
This scale will be applied at the moment of the induction by the anesthesiologist
Measured: 30 minuts
Changes in postoperative behavior
The Post Behavioral Behavior Change Questionnaire (PHBQ) will be applied at the postoperative surgical control (7-10 days after the intervention). This survey will be applied by people trained by the hospital's pediatric psychiatry team The higher the score, the more behavioral changes in the postoperative period
Measured: 10 days
Emergence delirium
In the post-anesthesia recovery unit, the Emergency Delirium Scale for Pediatric Anesthesia (PAED) will be applied every 15 minutes during the first 30 minutes of their stay in the unit. Score goes from 0 to 20. Scores greater than 10 is considered as delirium.
Measured: 1 hour
Parents Satisfaction
A gradual scale will be applied to the parents of the patient upon discharge from hospital.
Measured: 10 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start4 Jul 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Under General AnaesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Tablet Group: They'll receive a tablet with content adapted to every group. It will be divided into 4 groups (2-4 years, 4-6 years, 6-8 years and 9-10 years). The first one will receive cartoons, the second will also have games; for the other two groups will be assigned appropriate video games depending on the age. Midazolam group: They'll receive 0,5mg/kg oral or it's equivalent in rectal administration 30 minutes to one hour prior to transfer to the theater. This patients will not be able to have contact with audiovisual devices.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Carlos Van Buren
- Responsible party
- Principal investigator, Nathalie Lopez, Universidad de Valparaiso
- Investigators
- Nathalie López, MD, Study director, Universidad de Valparaíso ChileAnamaria Correa, MD, Principal investigator, Universidad de Valparaíso Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531359
- Sponsor's protocol ID
- UV-1-2018
- Acronym
- TABLET
- Status last verified
- Sep 2018
- First submitted
- 30 Apr 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03531359
- Acronym / sponsor ID
- TABLET / UV-1-2018
- Conditions
- Children Under General Anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Hospital Carlos Van Buren
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 21 May 2018 (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.
Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.
Detailed description
It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.
For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.
There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Tablet Group: They'll receive a tablet with content adapted to every group. It will be divided into 4 groups (2-4 years, 4-6 years, 6-8 years and 9-10 years). The first one will receive cartoons, the second will also have games; for the other two groups will be assigned appropriate video games depending on the age. Midazolam group: They'll receive 0,5mg/kg oral or it's equivalent in rectal administration 30 minutes to one hour prior to transfer to the theater. This patients will not be able to have contact with audiovisual devices.
| Arm | Type | Receives |
|---|---|---|
| TIBD Tablet-based video distraction | Experimental | Device: TIBDChildren will receive of tablet-based interctive games in preoperatory room |
| Midazolam | Active comparator | Drug: MidazolamChildren will be premedicated with usual treatmente (midazolam) |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.
Key exclusion criteria (1 listed)
- Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections
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 |
|---|---|---|
| TIBDTable-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety. | Device | TIBD Tablet-based video distraction |
| MidazolamAdministration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater. | Drug | Midazolam |
Primary outcome
Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
Time frame: 6 hours
Difference between the measurement of the mYPAS-SF applied in the preoperative time and prior to induction. The scale has 18 items in 4 categories. Maximum score is 100 points. The higher the score, the greater the anxiety.
4 secondary outcomes
Cooperation with the induction
Time frame: 30 minuts
Changes in postoperative behavior
Time frame: 10 days
Emergence delirium
Time frame: 1 hour
Parents Satisfaction
Time frame: 10 minuts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Children Under General Anaesthesia
RecruitingObservational study
Clinical Performance and Failure Rates of Restorations Following Pediatric Dental Rehabilitation Under General Anesthesia
Pediatric Dental General Anesthesia, Restoration
Not yet recruiting
Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
Bite Force, Masseter Muscle
RecruitingPhase 4
Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
Pain, Postoperative
RecruitingPhase 4
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified
Recruiting
BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia
Endotracheal Extubation, Airway Anesthesia
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.
Nathalie López, MD study director
Universidad de Valparaíso Chile
Anamaria Correa, MD principal investigator
Universidad de Valparaíso Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIBD and Midazolam in people with Children Under General Anaesthesia, run by Universidad de Valparaiso at 1 site in Chile.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2018. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie López, MD (2364000, nathalielopez.jq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF) (time frame: 6 hours). 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 5 Sep 2018.