AnxietyNCT04049201
Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
A study testing elective surgery, Midazolam and Interactive Tablet in people with Anxiety, run by Hôpital d'enfants Béchir-Hamza at 1 site in Tunisia.
Trial summary
preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders. to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Anxiety
- What is being tested?
- elective surgery, Midazolam and Interactive Tablet
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTunisia
- Study dates
- 4 May 2018to 19 May 2019
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-10 years old children
- elective surgery
- ASA PS I/II
Who cannot join
- Parental refusal
- Emergency procedure
- Behavioral or psychiatric disorders
- allergy or hypersensitivity to midazolam
Trial locations and contacts
1 site in 1 country.
About this study
preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders.
to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet.
the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery
Read the detailed description
this study is a prospective,randomized, active treatment controlled trial.It enrolls 100 children .
after written and informed consent,the study participants were randomly assigned using a computer generated table to one of two treatment groups prior to elective surgery.
Group T: will receive an interactive tablet containing many cartoon's videos 20 minutes before the parental separation and until the anesthesia induction Group MD:will receive oral midazolam 20 minutes before parental separation with 0.5 mg/kg (max 20mg) Anxiety assessement was done using the Modified Yale Perioperative Anxiety Scale( MYPAS) at the separation of parents,the admission in the operating room and the anesthesia induction.
Facial mask acceptance,post operative agitation (PAEDS score: Pediatric Anesthesia Emergence of Delirium) and parental satisfaction were also assessed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective surgeryProcedure or surgery
Also called we will study the acceptance of the facial mask,the post operative delirium and the parents satisfaction
investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
MidazolamDrug
Oral Midazolam
Interactive TabletDevice
interactive Tablet containing many cartoon's videos
| Study group | Role | What they receive |
|---|---|---|
| Group tablet | Experimental | group T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction Receives: Procedure: elective surgery; Device: Interactive Tablet |
| Group Midazolam | Active comparator | group Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation Receives: Procedure: elective surgery; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety
preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale (MYPAS)at different time prior to elective surgery .the averaged score range from 24.9: no anxiety to 100 very anxious
Measured: 20 minutes after tablet was given
Preoperative anxiety
preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery .the averaged score ranges from 24.9 no anxiety to 100 very anxious
Measured: 25 minutes after tablet was given
Preoperative anxiety
preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery.the averaged score range from 24.9 no anxiety to 100 very anxious
Measured: 30 minutes after tablet was given
Secondary outcomes (3)
the acceptance of Facial mask
the acceptance of facial mask by an established score
Measured: 30 minutes after tablet was given
post operative agitation
post operative agitation was assessed using PAEDS which was calculated 10 to 15 minutes after the anesthetic wake up.
Measured: 10 to 15 minutes after wakeup of anesthesia
the parental satisfaction
by an established score
Measured: 1 hour after the wake up of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start4 May 2018
- Primary completion19 May 2019
- Study completion19 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital d'enfants Béchir-Hamza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sonia ben khalifa (PhD), Hôpital d'enfants Béchir-Hamza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049201
- Sponsor's protocol ID
- 02/2019
- Status last verified
- May 2019
- First submitted
- 18 Mar 2019
- Last updated
- 8 Aug 2019
- 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 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children
- ClinicalTrials.gov ID
- NCT04049201
- Acronym / sponsor ID
- 02/2019
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hôpital d'enfants Béchir-HamzaUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 19 May 2019 (actual)
- Study completion
- 19 May 2019 (actual)
- First posted
- 8 Aug 2019 (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.
preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders.
to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet.
the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery
Detailed description
this study is a prospective,randomized, active treatment controlled trial.It enrolls 100 children .
after written and informed consent,the study participants were randomly assigned using a computer generated table to one of two treatment groups prior to elective surgery.
Group T: will receive an interactive tablet containing many cartoon's videos 20 minutes before the parental separation and until the anesthesia induction Group MD:will receive oral midazolam 20 minutes before parental separation with 0.5 mg/kg (max 20mg) Anxiety assessement was done using the Modified Yale Perioperative Anxiety Scale( MYPAS) at the separation of parents,the admission in the operating room and the anesthesia induction.
Facial mask acceptance,post operative agitation (PAEDS score: Pediatric Anesthesia Emergence of Delirium) and parental satisfaction were also assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group tablet | Experimental | Procedure: elective surgery, Device: Interactive Tabletgroup T will receive interactive Tablet containing many cartoon's videos 20 minutes before parental separation until the anesthesia induction |
| Group Midazolam | Active comparator | Procedure: elective surgery, Drug: Midazolamgroup Midazolam will receive oral midazolam 0.5 mg/kg (max 20 mg) 20 minutes before the parental separation |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 3-10 years old children
- elective surgery
- ASA PS I/II
Key exclusion criteria (4 listed)
- Parental refusal
- Emergency procedure
- Behavioral or psychiatric disorders
- allergy or hypersensitivity to midazolam
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 |
|---|---|---|
| elective surgeryAlso: we will study the acceptance of the facial mask,the post operative delirium and the parents satisfactioninvestigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery | Procedure or surgery | Group Midazolam, Group tablet |
| MidazolamOral Midazolam | Drug | Group Midazolam |
| Interactive Tabletinteractive Tablet containing many cartoon's videos | Device | Group tablet |
Primary outcome
Preoperative anxiety
Time frame: 20 minutes after tablet was given
preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale (MYPAS)at different time prior to elective surgery .the averaged score range from 24.9: no anxiety to 100 very anxious
Preoperative anxiety
Time frame: 25 minutes after tablet was given
preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery .the averaged score ranges from 24.9 no anxiety to 100 very anxious
Preoperative anxiety
Time frame: 30 minutes after tablet was given
preoperative anxiety will be measured by the modified Yale Perioperative Anxiety Scale(MYPAS)at different time prior to elective surgery.the averaged score range from 24.9 no anxiety to 100 very anxious
3 secondary outcomes
the acceptance of Facial mask
Time frame: 30 minutes after tablet was given
post operative agitation
Time frame: 10 to 15 minutes after wakeup of anesthesia
the parental satisfaction
Time frame: 1 hour after the wake up of anesthesia
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 8 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 elective surgery, Midazolam and Interactive Tablet in people with Anxiety, run by Hôpital d'enfants Béchir-Hamza at 1 site in Tunisia.
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 3 inclusion and 4 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 8 Aug 2019. 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 Tunisia. 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?
Preoperative anxiety (time frame: 20 minutes after tablet was given). The study lists 3 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 8 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.