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

NCT07693842 | Not Yet Recruiting

• 1 other identifier: SKaya_003
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Taking a Throat Swab

Keywords

throat swab; therapeutic play; animation video; child; fear; emotional expression; anxiety

Outcome Measures

Primary Outcomes (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.

  Before İntervention and after procedure(throat swab)

Study Arms (3)

Animation video

EXPERIMENTAL

In this group, the children will be shown a video explaining the throat swab procedure

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.

Other: Therapeutic Play

control group

NO INTERVENTION

In this group, throat swab tests will be carried out on children in the usual manner.

Interventions

Animation video OTHER

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

Animation video

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.

therapeutic play

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sümeyye Kaya Kocagil, PHD.

CONTACT

+9 5546546865; sumeyye93@mersin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the research, it is not possible to blind the researcher and the participants. Blinding will only be applied during the analysis of the research data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resarch Assistant

Model Details: The study will be conducted using a single-centre, three-arm, parallel-group, randomised controlled design.

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 9, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

TU (1)