Actively Recruiting

Phase Not Applicable
Age: 4Years - 8Years
All Genders
ID06600113

Evaluating Effectiveness of Different Educational Methods on the Anxiety of Children Undergoing Anaesthesia - a Randomized Controlled Trial

Led by University of Iceland · Updated on 2024-09-19

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how different educational methods affect anxiety in children aged 4 to 8 who are undergoing anesthesia. This randomized controlled trial compares an educational health game, a similar story-based educational material, and usual care to see which method best helps reduce children's anxiety before anesthesia. The study includes children and their parents, aiming to improve patient education through innovative computer games and provide valuable information on managing anxiety related to anesthesia. Participants are divided into three groups: one group plays a specially designed educational mobile game within one week before their medical procedure, which teaches them what to expect and coping strategies. Another group is read an illustrated story by their parents covering similar information. The third group receives the usual care, where they get information from health personnel as standard preparation. Data collection occurs at four time points including before the intervention, at the hospital during preparation for anesthesia, immediately before anesthesia induction, and a few days after the operation. During the study, parents complete questionnaires about their own anxiety and their child's temperament and experience. Nurses observe the child's anxiety levels in the hospital using a standard anxiety scale, as well as noting behaviors like crying or calmness upon waking. Medical records related to the procedure and premedication are also reviewed. The main outcome measured is the child's anxiety before anesthesia, assessed twice on the day of surgery. The study participation comprises multiple assessments to track anxiety and experiences over time.

CONDITIONS

Brief Title

Effect of Educational Intervention on Children's Anxiety

Who Can Participate

Age: 4Years - 8Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 4 to 8 years
  • Scheduled to undergo anesthesia for a medical procedure
  • Ability to understand Icelandic or Finnish
  • Parent or guardian available to complete questionnaires
Not Eligible

You will not qualify if you...

  • Does not understand Icelandic or Finnish language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Educational Intervention

Duration - Up to 1 week

Participants engage in one of three educational methods within one week before their medical procedure: playing an educational game, listening to a storytelling session, or receiving usual care information.

1 to 2 visits depending on educational method

Hospital Procedure Day

Duration - 1 day

Participants undergo anesthesia for their medical procedure. Anxiety assessments are conducted in the waiting room and just before induction of anesthesia. Nurses also observe the child's anxiety and behavior after waking up.

1 visit (in-person) on procedure day

Post-Anesthesia Follow-up

Duration - 2 to 4 days

Parents complete questionnaires about their child's experience with anesthesia 2 to 4 days after the operation.

1 follow-up visit or contact

Trial Site Locations

Total: 1 location

1

Laeknastofur Akureyrar

Akureyri, Iceland

Actively Recruiting

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Research Team

B

Brynja Ingadottir, Ph.D

A

Anna O. Sigurdardottir, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

3

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