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Taking a Throat SwabNCT07693842

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 study testing Animation video and Therapeutic Play in people with Taking a Throat Swab, run by Mersin University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 4 to 8 years
Conditions the study is for
Taking a Throat Swab
What is being tested?
Animation video and Therapeutic Play
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jul 2026to 15 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sümeyye Kaya Kocagil, PHD. contact

+9 5546546865

sumeyye93@mersin.edu.tr

Turkey (Türkiye)1 site
  • Mersin University

    Mersin, 33343

    Sümeyye Kocagil, sum93smk@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Animation video, Therapeutic Play
Keywords
throat swab, therapeutic play, animation video, child, fear, emotional expression, anxiety
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Animation videoOther

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

  • Therapeutic PlayOther

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

Study groups in NCT07693842
Study groupRoleWhat they receive
Animation videoExperimentalIn this group, the children will be shown a video explaining the throat swab procedure
Receives: Other: Animation video
therapeutic playExperimentalIn this group, the procedure will be explained to the children through therapeutic play incorporating gamification elements, during which they will undergo a throat swab test.
Receives: Other: Therapeutic Play
control groupNo interventionIn this group, throat swab tests will be carried out on children in the usual manner.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Before İntervention and after procedure(throat swab)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start25 Jul 2026 (estimated)
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be conducted using a single-centre, three-arm, parallel-group, randomised controlled design.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07693842
Sponsor's protocol ID
SKaya_003
Status last verified
Jul 2026
First submitted
5 Jul 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided. A final decision regarding individual participant data sharing has not yet been made. Any future sharing will take into account the protection of paediatric participants, ethical approval, confidentiality requirements, and applicable data protection regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Animation video and Therapeutic Play in people with Taking a Throat Swab, run by Mersin University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sümeyye Kaya Kocagil, PHD. (+9 5546546865, sumeyye93@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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