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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Consumer Satisfaction

Intervention / Treatment
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* Behavioral: Specific information brochure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information brochure<br>Intervention: The parents are given a specific information brochure that describes the procedures that the child is going through during anesthesia when it has been decided that the child is going to have the surgery. | Behavioral: Specific information brochure<br>* 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.<br>|
| No Intervention: Information as usual<br>Information as usual, i.e. oral information about the procedures to parents when they arrive at the hospital with the child that is going to have the surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with information | 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) | 10 minutes | 
| Preparedness for the operating room setting | 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) | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Score (PSS-14) | 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. | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parents, Patient Education as Topic, Preoperative Care, Pamphlets