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

NCT ID: NCT03763292

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2020-07-03

Brief Summary

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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

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Conditions

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Anxiety Consumer Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Specific information brochure

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siri Forsmo, phd prof

Role: STUDY_DIRECTOR

Norwegian University for Science and Technology

Locations

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Sykehus Levanger

Levanger, , Norway

Site Status

Countries

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Norway

Other Identifiers

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REK2018/1830

Identifier Type: -

Identifier Source: org_study_id

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