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NCT Number: NCT07693842

The Effect of Animated Videos and Therapeutic Play Methods on Emotional Expression, Fear and Anxiety in Children Aged 4-8 Years During the Throat Swab Procedure

We planned a study to determine the effect of showing an animated video and using educational therapeutic play methods prior to throat swab procedures in children aged 4-8 years on the children's compliance with the procedure, as well as on their emotional expression, fear and anxiety levels, and to compare the superiority/effectiveness of these two methods against one another. The sample size for the study was determined using an a priori power analysis conducted with the G*Power (v3.1.9.7) programme. It is planned to include a total of 105 children, with at least 35 children in each group. The study will be conducted using a single-blind, parallel-group, three-group experimental design. By demonstrating the effects of two different modern approaches on children's compliance, fear, anxiety and emotional responses during the throat swab procedure, this study will contribute to the development of evidence-based, atraumatic care practices in paediatric clinics.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location contact

Sümeyye Kocagil

CONTACT

[email protected]

About this study

Hospital visits during childhood and the diagnostic and medical procedures carried out during these visits cause high levels of fear, anxiety and stress in children. The throat swab procedure, frequently used in the differential diagnosis of upper respiratory tract infections, is perceived by children as a threatening and invasive procedure due to the physical contact with the pharynx and the triggering of the gag reflex (Sajeev et al., 2021). Children aged 4-8, due to their developmental characteristics, may struggle to comprehend abstract concepts and may therefore interpret such procedures as punishment or an attack on their bodily integrity (Vakili et al., 2025). The intense anxiety and fear experienced during the procedure make it difficult for children to comply with treatment, leading to negative emotional expressions such as crying and resistance, and undermining the future healthcare professional-patient relationship (Şengül & Erkut, 2025).

In paediatric nursing and the philosophy of atraumatic care, minimising the psychological and physiological trauma children experience as a result of medical procedures is one of the primary objectives. The literature indicates that audiovisual distraction techniques using animated videos to reduce children's anxiety and fears, and instructional therapeutic play-which helps children learn by making the steps of a process tangible-are effective non-pharmacological methods (Suleiman-Martos et al., 2022; Altay et al., 2025). However, there are few randomised controlled trials directly comparing the effectiveness of the 'instructional animation video' method with that of 'therapeutic play'-which enables the child to experience the process and gain a sense of control-in a procedure such as a throat swab, which is sudden and highly uncomfortable.

This study will contribute to the development of evidence-based, atraumatic care practices in paediatric clinics by demonstrating the effect of two different modern approaches on children's compliance, fear, anxiety and emotional responses during the throat swab procedure.

Research Hypotheses:

H0: There is no difference in the levels of emotional expression, fear and anxiety among children who undergo the throat swab procedure following the use of animated videos and therapeutic play methods.

he study will utilise the Children's Emotional Expression Assessment Scale ,the Children's Fear Scale, the Children's Fear Scale.

The animation and therapeutic game (playing cards) to be created for the intervention group will be developed by the researchers and implemented following consultation with experts.

Randomisation: In the study, patients meeting the inclusion criteria will be allocated to groups using a simple randomisation method (randomizer.org) to the animation video and therapeutic game (game cards) groups. The allocation of groups will be concealed using sequentially numbered opaque envelopes. The study will be conducted as a single-blind trial during the data analysis phase. Descriptive data will be analysed using frequency, percentage, mean, standard deviation, minimum and maximum values. In the analysis of comparative data between the case and control groups, parametric or non-parametric tests will be used, depending on whether the data follow a normal distribution.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children whose parents have provided written informed consent, who have had a throat swab taken at a paediatric clinic, who have verbally agreed to participate in the study, aged between 4 and 8 years, with no cognitive or neurological differences, with no visual or hearing impairment.

Exclusion criteria

Children whose parents have not provided written informed consent, who have not had a throat swab taken at a paediatric clinic, who have not verbally agreed to participate in the study, younger than 4 years or older than 8 years, with cognitive or neurological differences, with visual or hearing impairment.

Treatment and study plan

Animation video

Other

The animated video will be produced as a short video explaining the process carried out by the researchers.

Therapeutic Play

Other

Therapeutic play will be planned to incorporate elements of gamification. The child will be encouraged to carry out the activity using a toy.

Primary outcomes

  1. Changes in children's scores on scales measuring anxiety, fear and emotional expression before and after the intervention

    Time frame: Before İntervention and after procedure(throat swab)

    Following the children's scores on the pre-intervention scales measuring anxiety, fear and emotional expression, the intervention will be carried out, followed by a throat swab. A second assessment will be conducted post-intervention to examine differences between the groups in changes to their scores on the scales.

Study contacts

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

Sümeyye Kaya Kocagil, PHD.

CONTACT

[email protected]

+9 5546546865

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

The Effect of Animated Videos and Therapeutic Play Methods on Emotional Expression, Fear and Anxiety in Children Aged 4-8 Years During the Throat Swab Procedure: A Randomised Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

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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