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

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ClinicalTrials.gov Identifier: NCT03763292
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Levanger Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE November 30, 2018
First Posted Date  ICMJE December 4, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE December 10, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2018)
  • 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)
  • Preparedness for the OR 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)
Change History Complete list of historical versions of study NCT03763292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2018)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery
Official Title  ICMJE Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery on the Parents' Preparedness for Anesthesia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety
  • Consumer Satisfaction
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mari Liaklev Trønnes +47 45505194 mariliak@stud.ntnu.no
Contact: Sigrid Nakrem, phd prof +47 73412163 sigrid.nakrem@ntnu.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03763292
Other Study ID Numbers  ICMJE REK2018/1830
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE Levanger Hospital
Investigators  ICMJE
Study Director: Siri Forsmo, phd prof Norwegian University for Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP