Preoperative AnxietyPhase 4EPPANCT03530670
Effect of Premedication Type on Preoperative Anxiety in Children
A Phase 4 study testing oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor. and Playing smartphone game in people with Preoperative Anxiety, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor. and Playing smartphone game
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Aug 2018to 30 Jun 2019
- Phase
- Phase 4
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA 1-2
- Elective surgery
Who cannot join
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
- Hearing/visual impairment
- History of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Three Different Interventions on Preoperative Anxiety in Children
Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy
Read the detailed description
Compare the effects of 0.5 mg/kg oral midazolam, watching film 'Suko is being operated' animation film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU , playing smartphone game ( subway surfers, snail Bob or angry birds) on preoperative anxiety by m-YPAS in the holding area, in the operating room and while induction of anesthesia.
Investigators also evaluated mask acceptance by Mask Acceptance Scale Investigators also evaluated post operative delirium by PAED (postanesthetic emergency delirium) scale at PACU at arrive and every 10 minutes.
- Conditions
- Preoperative Anxiety
- Being tested
- oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor., Playing smartphone game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral midazolamOther
Also called demizolam
0.5 mg/kg oral midazolam administered 20 minutes before anesthesia induction
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.Other
Patients will be watched a short movie (at URL:
http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) 20 minutes before induction.
Playing smartphone gameOther
Patients will be played with smartphone (angry birds, subway surfers or snail Bob) 20 minutes before induction
| Study group | Role | What they receive |
|---|---|---|
| oral midazolam (demizolam) | Active comparator | To prevent preoperative anxiety patient premedicated by 0.5 mg/kg oral midazolam.
In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale Receives: Other: oral midazolam |
| http://www.animaturk.com/animasyon/suko-ameliyat-oluyor. | Active comparator | To prevent preoperative anxiety by watching a short movie ( at http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.) In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale Receives: Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor. |
| playing smartphone game | Active comparator | To prevent preoperative anxiety by playing smartphone game ( angry birds, subway surfers, snail Bob) In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale Receives: Other: Playing smartphone game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in preoperative anxiety
Preoperative anxiety will be evaluated by mYPAS (modified Yale Preoperative Anxiety Scale) The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization and use of parents). The highest behavioral level observed in each of the five mYPAS categories is the score for that category. Partial weights were calculated and then added to a total score that ranged from 0 to 100. Cut off points were set to classify: a score of 23.4 to 30 for no anxiety, any score greater than 30 for anxiety.
Change in preoperative anxiety from premedication to 20 minutes after premedication, from 20 minutes after premedication to entrance to the operating room at anesthesia induction will be evaluated.
Measured: Before premedications, 20 minutes after premedications, in operating room, at anesthesia induction.
Secondary outcomes (2)
Emergence agitation
Emergence agitation will be evaluated by PAED scale (pediatric anesthesia emergence delirium) The PAED scale involves five items: eye contact, purposeful actions, awareness of the surroundings, restlessness, inconsolability. First three items are scored as follows: 4= not at all, 3= just a little, 2= quite a bit, 1= very much, 0= extremely. Last two items are scored as follows: 0= not at all, 1= just a little, 2= quite a bit, 3= very much, 4= extremely. The scores of each item will summed to obtain a total score. PAED scale score of 10 or more will be defined as emergence delirium.
Measured: Postoperative every 10 minutes from entrance to the recovery room until discharge. If there is not a problem, patients are watched 20 minutes in our hospital's recovery room.
Mask acceptance score while mask induction
Anaesthesia will be induced with sevoflurane 8% and N2O 50% in oxygen by mask ventilation. The child's reaction to the mask will be evaluated by a mask acceptance scale. Mask acceptance scale to be used when assessing the child's mask acceptance is:
- Excellent: not scared, accepts mask easily
- Good: slightly scared of mask, could be calmed down easily
- Moderate: scared of mask, could not be calmed down
- Poor: crying, movement of arms and legs, struggling
Measured: At anesthesia induction
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 start6 Aug 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bahar SAKIZCI UYAR, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530670
- Sponsor's protocol ID
- 42/05
- Acronym
- EPPA
- Status last verified
- Jul 2019
- First submitted
- 18 Apr 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sakizci Uyar B, Polat R, Bolat M, Donmez A. Which is good for pre-operative anxiety? Midazolam, video games or teaching with cartoons: A randomised trial. Eur J Anaesthesiol. 2021 Jul 1;38(7):744-750. doi: 10.1097/EJA.0000000000001384.
PubMed 33186304
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Interventions on Preoperative Anxiety in Children
- ClinicalTrials.gov ID
- NCT03530670
- Acronym / sponsor ID
- EPPA / 42/05
- Conditions
- Preoperative Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- 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.
Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy
Detailed description
Compare the effects of 0.5 mg/kg oral midazolam, watching film 'Suko is being operated' animation film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU , playing smartphone game ( subway surfers, snail Bob or angry birds) on preoperative anxiety by m-YPAS in the holding area, in the operating room and while induction of anesthesia.
Investigators also evaluated mask acceptance by Mask Acceptance Scale Investigators also evaluated post operative delirium by PAED (postanesthetic emergency delirium) scale at PACU at arrive and every 10 minutes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety
| Arm | Type | Receives |
|---|---|---|
| oral midazolam (demizolam) | Active comparator | Other: oral midazolamTo prevent preoperative anxiety patient premedicated by 0.5 mg/kg oral midazolam. In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale |
| http://www.animaturk.com/animasyon/suko-ameliyat-oluyor. | Active comparator | Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.To prevent preoperative anxiety by watching a short movie ( at http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.) In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale |
| playing smartphone game | Active comparator | Other: Playing smartphone gameTo prevent preoperative anxiety by playing smartphone game ( angry birds, subway surfers, snail Bob) In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA 1-2
- Elective surgery
Key exclusion criteria (7 listed)
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
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 |
|---|---|---|
| oral midazolamAlso: demizolam0.5 mg/kg oral midazolam administered 20 minutes before anesthesia induction | Other | oral midazolam (demizolam) |
| Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.Patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) 20 minutes before induction. | Other | http://www.animaturk.com/animasyon/suko-ameliyat-oluyor. |
| Playing smartphone gamePatients will be played with smartphone (angry birds, subway surfers or snail Bob) 20 minutes before induction | Other | playing smartphone game |
Primary outcome
Change in preoperative anxiety
Time frame: Before premedications, 20 minutes after premedications, in operating room, at anesthesia induction.
Preoperative anxiety will be evaluated by mYPAS (modified Yale Preoperative Anxiety Scale) The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization and use of parents). The highest behavioral level observed in each of the five mYPAS categories is the score for that category. Partial weights were calculated and then added to a total score that ranged from 0 to 100. Cut off points were set to classify: a score of 23.4 to 30 for no anxiety, any score greater than 30 for anxiety. Change in preoperative anxiety from premedication to 20 minutes after premedication, from 20 minutes after premedication to entrance to the operating room at anesthesia induction will be evaluated.
2 secondary outcomes
Emergence agitation
Time frame: Postoperative every 10 minutes from entrance to the recovery room until discharge. If there is not a problem, patients are watched 20 minutes in our hospital's recovery room.
Mask acceptance score while mask induction
Time frame: At anesthesia induction
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 26 Jul 2019.
- Derived from this study: PubMed 33186304Sakizci Uyar B, Polat R, Bolat M, Donmez A. Which is good for pre-operative anxiety? Midazolam, video games or teaching with cartoons: A randomised trial. Eur J Anaesthesiol. 2021 Jul 1;38(7):744-750. doi: 10.1097/EJA.0000000000001384.
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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 Phase 4 study testing oral midazolam, Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor. and Playing smartphone game in people with Preoperative Anxiety, run by Diskapi Yildirim Beyazit Education and Research Hospital 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 7 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 26 Jul 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in preoperative anxiety (time frame: Before premedications, 20 minutes after premedications, in operating room, at anesthesia induction.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03530670, which also lists 1 linked publication.
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 26 Jul 2019.