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CompletedNCT03763292Updated Jul 7, 2020

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

An interventional study of Specific information brochure in Anxiety and Consumer Satisfaction, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety
  • Consumer Satisfaction

Keywords

  • Parents
  • Patient Education as Topic
  • Preoperative Care
  • Pamphlets
03

In context

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Parents who do not speak nor read Norwegian.
  • Parents who do not want to participate
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
45 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralSpecific 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 10 minutes

  2. 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)

    Time frame: 10 minutes

Secondary outcomes

  1. 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.

    Time frame: 10 minutes

07

Study locations

1 site
  • Sykehus Levanger
    Levanger, Norway
08

References and documents

Individual participant data

Plan to share: Yes — Anonymous participant data plotted in a SPSS file can be shared on request.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03763292
Lead sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF
Responsible party
Sponsor
First posted
Dec 4, 2018
Start date
Dec 10, 2018
Primary completion
Jul 3, 2020
Completion
Jul 3, 2020
Last update
Jul 7, 2020

Study contacts

Siri Forsmo, phd prof
study director · Norwegian University for Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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