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Salivary Cortisol level to assess Anxiety of children before surgery with the use or not of medicine

Salivary Cortisol and preoperative Anxiety level of children with the use or not of pre-medication: clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-6kzpwyk
Enrollment
Unknown
Registered
2024-06-28
Start date
2024-10-01
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

This is a three-arm, unblinded, randomized controlled clinical study. Participants will be randomized using software, organized by a researcher who is not part of this research and each participant wi

Sponsors

Instituto de Medicina Integral Professor Fernando Figueira
Lead Sponsor
Instituto de Medicina Integral Professor Fernando Figueira
Collaborator

Eligibility

Age
2 Years to 9 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 9 years; both genders; indication of small and medium-sized elective surgery; literate responsible

Exclusion criteria

Exclusion criteria: Children who receive chronic medications that depress the central nervous system, such as for the treatment of autism spectrum disorder, attention deficit hyperactivity disorder; american society of anesthesia classification greater than II; use of corticosteroids; carrying out dental treatment in the 24 hours before surgery; surgeries performed after 10 am, a time defined due to the circadian cycle, which causes a bias in the collection of salivary cortisol

Design outcomes

Primary

MeasureTime frame
It is expected to find a reduction in anxiety of around 40% in the group that will undergo drug intervention, observed through comparison with the other two groups, control and intervention through videos. Descriptive statistics will be performed on the data with frequency and percentage for qualitative variables and mean, standard deviation, median and minimum and maximum values ??for quantitative variables. To verify the association between groups and categorized explanatory variables, a Chi-square or Fisher's Exact Test will be performed when necessary.

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactCarlos Guarana

Instituto de Medicina Integral Professor Fernando Figueira

viniciusguarana@hotmail.com+55-81-2122-4756

Outcome results

None listed

Source: REBEC (via WHO ICTRP)