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

NCT03763292 | Completed

• 1 other identifier: REK2018/1830
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Consumer Satisfaction

Keywords

Parents; Patient Education as Topic; Preoperative Care; Pamphlets

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Perceived Stress Score (PSS-14)

  10 minutes

Study Arms (2)

Information brochure

EXPERIMENTAL

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

Information as usual

NO INTERVENTION

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.

Interventions

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.

Information brochure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Helse Nord-Trøndelag HF: collaborator

Study Sites (1)

Sykehus Levanger

Levanger, Norway

Location

MeSH Terms

Conditions

Anxiety Disorders; Consumer Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Siri Forsmo, phd prof

  Norwegian University for Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 4, 2018
• Study Start: December 10, 2018
• Primary Completion: July 3, 2020
• Study Completion: July 3, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: September 2019 - August 2024 (5 years)
• Access Criteria: Request to contact persons.

Locations

NO (1)