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Comparison of the effects of the use of tablet computer and midazolam to suppress surgical stress of children

The effect of using tablet computer on surgical stress .

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000750987
Enrollment
120
Registered
2020-07-21
Start date
2020-08-10
Completion date
2020-09-11
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Anxiety is a typical response expected from a child in an unusual circumstance. Pharmacological methods and non-pharmacological methods have been used to reduce the child’s anxiety. We investigate the effects of the pharmacological method of oral midazolam with the non-pharmacological method of playing games on a tablet computer on children with and without anxiety.

Interventions

In the study, we aim to compare the effects of oral midazolam and tablet computer for premedication in patients with anxiety and non-anxiety in children planned for operations under general anesthesia with the diagnosis of circumcision desire, inguinal hernia, hydrocele, and undescended testes. All these interventions will be managed by anesthesiologists. 1- Lego Juniors, Talking Tom Cat, Racing Penguin, Subway surfers, Air hockey, Cut the Rope games will be offered for children ages 4-10. 2- Pa

In the study, we aim to compare the effects of oral midazolam and tablet computer for premedication in patients with anxiety and non-anxiety in children planned for operations under general anesthesia with the diagnosis of circumcision desire, inguinal hernia, hydrocele, and undescended testes. All these interventions will be managed by anesthesiologists. 1- Lego Juniors, Talking Tom Cat, Racing Penguin, Subway surfers, Air hockey, Cut the Rope games will be offered for children ages 4-10. 2- Participants will be given a tablet computer 30 minutes before the operation. After that 30 minutes, the pediatric patient will be evaluated in his/her room. And then, the pediatric patient will be re-evaluated when leaving the family to go to the operating room. Finally, when inhalation induction is performed, its response to the anesthesia mask of the pediatric patient will be assessed again. When the child who is given a tablet computer to play games is seen by the nurse that the child does not play games with the tablet computer, this child is excluded from the study. When a child given peroral midazolam does not agree to take midazolam or is seen by the nurse, who is removed from the mouth, this child is excluded from the study.

Sponsors

University of Health Sciences Izmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

Age 4-10 years American Society of Anesthesiologists score 1 or 2 Children will be anesthetized for the first time for surgical procedures due to one of the following conditions: circumcision, inguinal hernia, hydrocele, undescended testis, hypospadias.

Exclusion criteria

Patients will not be included some circumstances where those had previous surgery, motor, and mental retardation, or chronic diseases, had been using psychiatric medication, had been planned to undergo more than one operation in the same session, had emergency surgery, or had an ASA score of 3 or 4.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026