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

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

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 Overview

• Status: Completed
• Conditions: Anxiety; Consumer Satisfaction
• Intervention / Treatment: Behavioral: Specific information brochure

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Levanger, Norway
    • Sykehus Levanger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Information brochure; 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; 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.
No Intervention: Information as usual; 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?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Helse Nord-Trøndelag HF
• Investigators: Study Director: Siri Forsmo, phd prof, Norwegian University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Actual): July 3, 2020
• Study Completion (Actual): July 3, 2020

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Parents; Preoperative Care; Pamphlets; Patient Education as Topic
• Other Study ID Numbers: REK2018/1830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous participant data plotted in a SPSS file can be shared on request.
• IPD Sharing Time Frame: September 2019 - August 2024 (5 years)
• IPD Sharing Access Criteria: Request to contact persons.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No