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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763292
• Other study ID #: REK2018/1830
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: July 3, 2020

Study information

• Verified date: July 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 3, 2020
• Est. primary completion date: July 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Consumer Satisfaction

Intervention

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.

Locations

Country	Name	City	State
Norway	Sykehus Levanger	Levanger

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Levanger Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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