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).
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.
Turkey (Türkiye)1 site
Mersin University
Mersin, 33343
Sümeyye Kocagil, sum93smk@gmail.com
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.
- Conditions
- Taking a Throat Swab
- 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 group | Role | What they receive |
|---|---|---|
| Animation video | Experimental | In this group, the children will be shown a video explaining the throat swab procedure Receives: Other: Animation video |
| therapeutic play | Experimental | In 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 group | No intervention | In 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.
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.
- First posted9 Jul 2026
- Study start25 Jul 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taking a Throat SwabStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SÜMEYYE KAYA KOCAGİL, Mersin University
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07693842
- Acronym / sponsor ID
- SKaya_003
- Conditions
- Taking a Throat Swab
- Keywords
- throat swab, therapeutic play, animation video, child, fear, emotional expression, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study will be conducted using a single-centre, three-arm, parallel-group, randomised controlled design.
| Arm | Type | Receives |
|---|---|---|
| Animation video | Experimental | Other: Animation videoIn this group, the children will be shown a video explaining the throat swab procedure |
| therapeutic play | Experimental | Other: Therapeutic PlayIn 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. |
| control group | No intervention | –In this group, throat swab tests will be carried out on children in the usual manner. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animation videoThe animated video will be produced as a short video explaining the process carried out by the researchers. | Other | Animation video |
| Therapeutic PlayTherapeutic play will be planned to incorporate elements of gamification. The child will be encouraged to carry out the activity using a toy. | Other | therapeutic play |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.