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OpenTrials
Completed

NCT Number: NCT03763292

Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Consumer Behavior Consumer Satisfaction Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sykehus Levanger

Levanger, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specific information brochure

Behavioral

A purpose-designed brochure about anesthesia and surgery in the ear in children is developed by the investigators. This brochure has photos and describes the procedures the child is going through.

Primary outcomes

  1. 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)

  2. 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

  1. Perceived Stress Score (PSS-14)

    Time frame: 10 minutes

    Self-reported perceived stress measured by 14 questions on a 5-point Likert scale where 1 is Never and 5 is very often. Range for the total score is 1-70.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Helse Nord-Trøndelag HF

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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