Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000612516
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
10/05/2024
Date last updated
10/05/2024
Date data sharing statement initially provided
10/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of preoperative informational pamphlet on perioperative anxiety in children
Scientific title
Effects of preoperative informational pamphlet on perioperative anxiety in children
Secondary ID [1] 310937 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 331998 0
Condition category
Condition code
Mental Health 328737 328737 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children aged 5-17 years, undergoing elective surgery were enrolled. During the anesthesiological visit that was conducted at least one day before surgery, the physician will give one brochure to the patient and one brochure to the caregivers. The patient's brochure contains pictures to color and it is written in a very simple (italian) language. We created two brochures based on the age of the patients (4-7 years considered as children or 8-17 years considered as adolescents). they explain how to best deal with the hospitalization period before surgery and after surgery. Similarly, in a more formal language, the parents' brochure helps them address the most common fears and questions regarding the time in hospital before and after their child's surgery. Anxiety was evaluated in children and parents during the anesthesiologic visit, before entering the operating room (at the time of separation), and before induction of anesthesia.
Intervention code [1] 327365 0
Treatment: Other
Comparator / control treatment
Children aged 5-17 years, with American Society of Anesthesiologist physical status I-II, undergoing elective surgery were enrolled. The control group received the standard preparation during the preoperative visit, where parents can have answers to their questions, and they can receive explanations from the anesthesiologists.
Control group
Active

Outcomes
Primary outcome [1] 336548 0
child's preoperative anxiety level.
Timepoint [1] 336548 0
during the anesthesiologic visit (primary timepoint) , before entering the operating room (at the time of separation from caretakers), and before induction of anesthesia.
Secondary outcome [1] 434340 0
parents preoperative anxiety level
Timepoint [1] 434340 0
during the anesthesiologic visit, before entering the operating room (at the time of separation from caretakers)

Eligibility
Key inclusion criteria
They were children aged between 5-17 undergoing general anesthesia, classified according to the American Association of Anesthesiologists as ASA I-II, who will undergo surgery at the Complex Operative Units (UOC) of Pediatric Surgery of the AOU Federico II. Parents should understand and speak Italian language.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were children with proven behavioral and cognitive impairment; use of psychoactive drugs; history of seizures, mental illness, or chronic pain

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/03/2024
Date of last participant enrolment
Anticipated
20/06/2024
Actual
Date of last data collection
Anticipated
26/06/2024
Actual
Sample size
Target
40
Accrual to date
36
Final
Recruitment outside Australia
Country [1] 25962 0
Italy
State/province [1] 25962 0
campania

Funding & Sponsors
Funding source category [1] 315420 0
Self funded/Unfunded
Name [1] 315420 0
Country [1] 315420 0
Primary sponsor type
University
Name
university of Naples Federico II
Address
via sergio pansini 5 80131 italy
Country
Italy
Secondary sponsor category [1] 318127 0
None
Name [1] 318127 0
Address [1] 318127 0
Country [1] 318127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314124 0
Federico II University Ethics Committee
Ethics committee address [1] 314124 0
Ethics committee country [1] 314124 0
Italy
Date submitted for ethics approval [1] 314124 0
16/04/2020
Approval date [1] 314124 0
22/04/2020
Ethics approval number [1] 314124 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130494 0
Miss serena nappi
Address 130494 0
via sergio pansini 5 Naples Italy 80131 - University Hospital Federico II
Country 130494 0
Italy
Phone 130494 0
+39 3409097225
Fax 130494 0
Email 130494 0
[email protected]
Contact person for public queries
Name 130495 0
serena nappi
Address 130495 0
via sergio pansini 5 Naples Italy 80131 - University Hospital Federico II
Country 130495 0
Italy
Phone 130495 0
+39 3409097225
Fax 130495 0
Email 130495 0
[email protected]
Contact person for scientific queries
Name 130496 0
serena nappi
Address 130496 0
via sergio pansini 5 Naples Italy 80131 - University Hospital Federico II
Country 130496 0
Italy
Phone 130496 0
+39 3409097225
Fax 130496 0
Email 130496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.