Effect of Educational Intervention on Children's Anxiety

NCT ID: NCT06600113

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2025-05-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Education and teaching of coping strategies

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Education and teaching of coping strategies

Intervention Type: OTHER

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

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Undergoing anesthesia for medical procedure

Exclusion Criteria

• Does not understand Icelandic/Finnish

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iceland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brynja Ingadottir, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Iceland

Locations

Laeknastofur Akureyrar

Akureyri, , Iceland

Site Status: RECRUITING

Countries

Iceland

Central Contacts

Brynja Ingadottir, Ph.D

Role: CONTACT

brynjain@hi.is

+3548651817

Anna O. Sigurdardottir, Ph.D

Role: CONTACT

annaos@landspitali.is

Facility Contacts

Bjorn Gunnarsson, Ph.D

Role: primary

Other Identifiers

UI-2022-MINA

Identifier Type: -

Identifier Source: org_study_id