Effect of Educational Intervention on Children's Anxiety (MINA)

September 12, 2024 updated by: University of Iceland

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

The aim of this randomized controlled trial is to evaluate the effectiveness of an educational health game intervention for children undergoing anesthesia from the perspective of children's anxiety. Participants are divided into three groups: one plays an educational game, another gets similar educational material (story) on a website and the third receives usual care. Anxiety will be evaluated with a standard assessment tool at the medical centre and parents answer questionnaires about themselves and their child. The study is an important step into innovation in the field of patient education where computer games are used to disseminate information, teach salvation and promote faith in the child's own ability and courage. The study will provide important information on children's anxiety for anaesthesia and what the effects of the computer game are compared to other educational methods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled trial. This study will evaluate the effectiveness of an educational health game intervention for children undergoing anesthesia from the perspective of children's anxiety. The data will be collected from children (4-8 years old) and their parent or guardian at four different time points: the baseline, post1, post-2 and post 3-intervention.

The sample size was calculated by statistician using power calculations. According to the calculations, the targeted sample size is in total 150 children (50 per each arm) in Finland and Iceland.

Participants are recruited from daycare surgery wards in university hospitals or hospitals where children undergo various procedures under anesthesia. The recruitment will be agreed separately with the hospital and hospital workers.

Data will be collected in four different time points.

  1. Before the intervention, baseline. Questionnaires for parent: the child's temperament is measured with Child Behaviour Questionnaire (CBQ) (Rothbart et al 2001), the anxiety of parent is measured with the State-trait Anxiety Inventory (STAI, trait part) (Spielberger, 1983) and background information of the child and parents.
  2. After the baseline questionnaires children are randomized to three groups. Group A: plays an educational mobile game, Group B: similar educational material on a website than in the health game, and Group C: the usual care (receives information from the health personnel) for preparation for the anesthesia.
  3. At the hospital. Questionnaire for parent: Parents answers the anxiety of parent (STAI, state part). Nurse observes child's anxiety in hospital using The Modified Yale Preoperative Anxiety Scale, mYPAS short form, (mYPAS-SF) (Jenkins et al. 2014) in the waiting room before the anesthesia (post 1) while the child is prepared for anesthesia and right before the induction of anesthesia (post 2). Nurse 2 also observes weather the child is particularly crying or calm when waking up. The nurse will collect information from the child's medical records for the study, such as the procedure the child has had and the reason for the procedure, premedication etc.
  4. After the anesthesia (post 3) Questionnaire for parent: 2-4 days after the operation questions regarding the experience of anesthesia.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brynja Ingadottir, Ph.D
  • Phone Number: +3548651817
  • Email: brynjain@hi.is

Study Contact Backup

Study Locations

  • Iceland
      • Akureyri, Iceland
        • Recruiting
        • Laeknastofur Akureyrar
        • Contact:
          • Bjorn Gunnarsson, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing anesthesia for medical procedure

Exclusion Criteria:

  • Does not understand Icelandic/Finnish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Game playing
Children play a specially designed educational game within one week of their medical procedure. The game informs the child what to expect at the day of the procedure and teaching coping strategies
Other: Education and teaching of coping strategies
the intervention consists of patient education for children, the same content delivered through either an educational game and storytelling
Active Comparator: Story telling
Children are read an illustrated story by their parent within one week of their medical procedure. The story informs the child what to expect at the day of the procedure and teaching coping strategies
Other: Education and teaching of coping strategies
the intervention consists of patient education for children, the same content delivered through either an educational game and storytelling
No Intervention: Usual care
These children get the usual care, information from their parents or doctor before the medical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative anxiety of children
Time Frame: Through study completion, twice a day of surgery: In the waiting room before anesthesia and just before induction of anesthesia.
Anxiety is measured with short version of the modified Yale Preoperative Anxiety Scale (mYPAS-SF) with observational scores from 22.9, minimal anxiety, to 100, maximal anxiety
Through study completion, twice a day of surgery: In the waiting room before anesthesia and just before induction of anesthesia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iceland

Investigators

  • Principal Investigator: Brynja Ingadottir, Ph.D, University of Iceland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2022

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UI-2022-MINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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