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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03763292|
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Consumer Satisfaction||Behavioral: Specific information brochure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||July 2019|
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.
- 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)
- 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.
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
|Contact: Mari Liaklev Trønnes||+47 firstname.lastname@example.org|
|Contact: Sigrid Nakrem, phd prof||+47 email@example.com|
|Contact: Mari Liaklev Trønnes +47 45505194 firstname.lastname@example.org|
|Study Director:||Siri Forsmo, phd prof||Norwegian University for Science and Technology|