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Comparative study between the effect of pharmacological and non-pharmacological measures on preoperative anxiety in preschoolers undergoing outpatient surgeries

Comparative study between the effect of pharmacological and non-pharmacological measures on preoperative anxiety in pediatric patients undergoing elective outpatient surgeries: prospective, randomized, blinded study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4d9d42n
Enrollment
Unknown
Registered
2023-02-08
Start date
2021-12-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Anxiety

Interventions

A short film (video) will be developed in cartoon format whose main character will be a child who will playfully tell the patient what will happen from his arrival at the hospital to the trip to the s

Sponsors

Casa de saúde assistência médica infantil de urgência
Lead Sponsor
Casa de saúde assistência médica infantil de urgência
Collaborator

Eligibility

Sex/Gender
Male
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: Patients who will undergo circumcision; aged between 2 and 7 years; with physical status according to the American Society of Anesthesiologists (ASA) I and II

Exclusion criteria

Exclusion criteria: Patients with Autism Spectrum Disorder (ASD); Attention Deficit Hyperactivity Disorder (ADHD); Patients with a previous history of paradoxical effect of Midazolam or hypersensitivity to any of its components; patient with serious diseases in organs such as kidney, liver, lung, heart, brain and bone marrow; patients who use psychostimulant drugs or antidepressants Serious diseases in organs such as kidney, liver, lung, heart, brain and bone marrow. Use of psychostimulant or antidepressant drugs

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: It was expected that the preoperative use of video in cartoon format would be able to promote anxiolysis in pediatric patients in a similar way to the effect of midazolam oral solution.To assess anxiety, the Yale scale was used.;Outcome found 1: Anxiety was quantified using the YALE scale. It was observed that children who watched the video were less anxious than children in the medication group and those in the control group. (p-value = 0.027).

Secondary

MeasureTime frame
Expected outcome 2: It is expected to find a shorter hospital stay in children in the control group and in the group that watched the video. To measure hospital stay, the interval between leaving the operating room and hospital discharge was considered.;Outcome found 2: It was observed that the children who watched the video were discharged more quickly, which resulted in a shorter hospital stay (p-value = 0.027).;Expected outcome 3: It was expected to observe that children who used midazolam solution would present more delirium when waking up from anesthesia compared to children in the control group and children who watched the video. Delirium on awakening was assessed using the PAED scale.;Outcome found 3: The percentage of children who showed delirium when waking up from anesthesia was higher in the group that used midazolam in relation to the control group and the group that watched the video (p-value < 0.0001). Delirium was measured using the PAED scale.

Countries

Brazil

Contacts

Public ContactLivia Berardinelli

Universidade Federal Fluminense

liliberardinelli@yahoo.com.br+55-021-99766-1654

Outcome results

None listed

Source: REBEC (via WHO ICTRP)