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NCT Number: NCT06600113

Effect of Educational Intervention on Children's Anxiety

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laeknastofur Akureyrar

Akureyri, Iceland

Location status: Recruiting

Location contact

Bjorn Gunnarsson, Ph.D

CONTACT

About this study

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.

  • 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.
  • 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.
  • 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.
  • After the anesthesia (post 3) Questionnaire for parent: 2-4 days after the operation questions regarding the experience of anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing anesthesia for medical procedure

Exclusion criteria

  • Does not understand Icelandic/Finnish

Treatment and study plan

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna O. Sigurdardottir, Ph.D

CONTACT

[email protected]

Brynja Ingadottir, Ph.D

CONTACT

[email protected]

+3548651817

Sponsors and collaborators

Lead sponsor

University of Iceland

Other

Registry information

Official study title

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

Acronym: MINA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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