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Effect of psychological preparation in the preoperative anxiety in children undergoing ambulatory surgery

Effect of psychological intervention in the preoperative anxiety of preschool children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5jh9sf
Enrollment
Unknown
Registered
2016-05-23
Start date
2014-11-06
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 in anestthesia in child for ambulatory surgical procedures in children (anxiety, anesthesia, child, ambulatory surgical procedures)

Interventions

Intervention group: 50 children and their parents were cared for in a psychology section where questions were developed as fear of anesthesia of parents and children and the moment of separation of ch
Behavioural
F04.096.628.193

Sponsors

Faculdade de Medicina de Jundiaí
Lead Sponsor
Faculdade de Medicina de Jundiaí
Collaborator

Eligibility

Age
2 Years to 8 Years

Inclusion criteria

Inclusion criteria: Children of both gender, aged 2-8 years classified as ASA I according to the American Association of anesthesiology, which were attended in the pre-anesthetic assessment clinic of the University Hospital of Jundiaí Medical School and undergoing surgery outpatient at the same hospital.

Exclusion criteria

Exclusion criteria: children with previous surgeries, the ones with confirmed behavioral and cognitive changes, users of psychoactive drugs, patients with history of convulsion, mental illness and chronic pain.

Design outcomes

Primary

MeasureTime frame
This trial has the primary end point expected to assess the impact of psychological treatment in reducing preoperative anxiety in children 2 to 8 years undergoing outpatient surgery. According to the prediction of the project was expected to 50% prevalence of anxiety in children and that the proposed intervention could reduce by 20% the anxiety of children after a study with 20 children. The authors proposed using alpha error of 5%, 20% beta error and 95% confidence interval. After analyzing the results the number of patients was determined in 42 in each group, totaling 84 in the proposed study. To evaluate the anxiety of children was used YALE Preoperative Anxiety Scale modified (EAPYm) where the anxiety level is measured in numbers ranging from 23.4 to 100. It is considered the presence of anxiety when the value is greater than or equal to 30. the higher the score, the higher anxiety. ;Primary endpoint found: The assessment 50 children in each distinct group. Statistical analysis was performed with the help of STATA / SE 9.0 for Windows. In the analysis of groups, medians and percentiles were used as a measure of central tendency and variability due to non normal tendency of the fractionated sample groups. Comparisons between groups for continuous variables was performed using the Mann-Whitney test. After evaluation and comparison of groups, a significant reduction was observed (p = 0.04) in the degree of anxiety in the group receiving psychological preparation compared to the control group.

Secondary

MeasureTime frame
secondary end point: to evaluate the degree of anxiety of parents at the moments of pre-anesthetic consultation and the moment of surgery in both groups and compare them. For this evaluation, we used the Visual Analogue Scale (VAS). The expected result is that the parents of the psychological preparation group exhibit reduced anxiety level compared to the control group and it is expected that there is a correlation between the degree of anxiety of parents and children.;Secondary end point found: Statistical analysis of results was performed using the Mann-Whitney test with values expressed as medians and percentiles and parents of the psychological preparation group showed significant reduction compared to the parents of the control group at the time of surgery (p = 0.01). No correlation was found between anxiety of parents and children in the consultation moment (p = 0.58) and surgery moment (p = 0.78). The test Spearman correlation was used to evaluate the intensity relations of the variables ordinating each other.

Countries

Brazil

Contacts

Public ContactJosé Fernando Meletti

Faculdade de Medicina de Jundiaí

jfmeletti@gmail.com55 (11) 4587 1095

Outcome results

None listed

Source: REBEC (via WHO ICTRP)