Effect of Educational Intervention on Children's Anxiety

NCT06600113 | Recruiting

• 1 other identifier: UI-2022-MINA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Literacy; Anesthesia; Anxiety; Fear; Attitude; Child Behavior; Health Knowledge, Attitudes, Practice

Keywords

Children; Game; Anesthesia; Health literacy

Outcome Measures

Primary Outcomes (1)

• Preoperative anxiety of children

  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.

Study Arms (3)

Game playing

EXPERIMENTAL

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

Story telling

ACTIVE COMPARATOR

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

Usual care

NO INTERVENTION

These children get the usual care, information from their parents or doctor before the medical procedure

Interventions

Education and teaching of coping strategies OTHER

the intervention consists of patient education for children, the same content delivered through either an educational game and storytelling

Game playing; Story telling

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Undergoing anesthesia for medical procedure

You may not qualify if:

• Does not understand Icelandic/Finnish

Sponsors & Collaborators

• University of Iceland: lead

Study Sites (1)

Laeknastofur Akureyrar

Akureyri, Iceland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Behavior; Child Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Brynja Ingadottir, Ph.D

  University of Iceland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brynja Ingadottir, Ph.D

CONTACT

+3548651817; brynjain@hi.is

Anna O. Sigurdardottir, Ph.D

CONTACT

annaos@landspitali.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: September 19, 2024
• Study Start: November 21, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)