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Clinical Trials/NCT03763292
NCT03763292CompletedNot Applicable

Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery on the Parents' Preparedness for Anesthesia

Norwegian University of Science and Technology1 site in 1 country45 target enrollmentStarted: December 10, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Satisfaction with information

Study Overview

Brief Summary

Children who will have surgery and need anesthesia, and their parents are often anxious and show signs of stress and discomfort. A main reason for concern and anxiety is fear of anesthesia and surgery, and lack of knowledge of what is going to happen. The purpose of the study is to see if a specific preoperative information brochure aimed at the parents will make the parents feel better prepared for the procedures.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Parents with children undergoing ear-nose-throat surgery in the study period

Exclusion Criteria

  • Parents who do not speak nor read Norwegian.
  • Parents who do not want to participate

Outcomes

Primary Outcomes

Satisfaction with information

Time Frame: 10 minutes

Self-reported satisfaction with provided information on a 5 point Likert scale where 1 is less satisfied and 5 is high satisfaction (range 1-5). In total four questions (sum score range 4-20)

Preparedness for the operating room setting

Time Frame: 10 minutes

Self-reported to what degree parents feel prepared as to what will happen before/during induction of anaesthesia on a 5 point Likert scale where 1 is less prepared and 5 is very well prepared (range 1-5). In total two questions (sum score range 2-10)

Secondary Outcomes

  • Perceived Stress Score (PSS-14)(10 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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