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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763292
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Helse Nord-Trøndelag HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Consumer Satisfaction Behavioral: Specific information brochure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery on the Parents' Preparedness for Anesthesia
Actual Study Start Date : December 10, 2018
Actual Primary Completion Date : July 3, 2020
Actual Study Completion Date : July 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Satisfaction with information [ Time Frame: 10 minutes ]
    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)

  2. Preparedness for the operating room setting [ Time Frame: 10 minutes ]
    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)


Secondary Outcome Measures :
  1. Perceived Stress Score (PSS-14) [ Time Frame: 10 minutes ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763292


Locations
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Norway
Sykehus Levanger
Levanger, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Helse Nord-Trøndelag HF
Investigators
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Study Director: Siri Forsmo, phd prof Norwegian University for Science and Technology
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03763292    
Other Study ID Numbers: REK2018/1830
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymous participant data plotted in a SPSS file can be shared on request.
Supporting Materials: Study Protocol
Time Frame: September 2019 - August 2024 (5 years)
Access Criteria: Request to contact persons.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Parents
Patient Education as Topic
Preoperative Care
Pamphlets