Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing

August 10, 2026 updated by: Atiye Karakul, Tarsus University

The Effect of Watching Cartoons and Using a Stress Ball on Fear, Anxiety, Pain, and Satisfaction During Allergy Testing in Children

This randomized controlled trial aims to evaluate and compare the effects of watching cartoons and using a stress ball on levels of fear, anxiety, pain, and satisfaction among 90 children aged 4-10 undergoing skin prick testing at the Pediatric Allergy Outpatient Clinic of Çukurova University Balcalı Hospital. Participants will be randomly allocated via a computer algorithm into three equal groups ($n = 30$ each): a cartoon-watching intervention group, a stress ball intervention group, and a control group receiving routine pediatric care. Data will be gathered using a Demographic Information Form, the Children's Fear Scale, the Children's Anxiety Scale-State, the Wong-Baker FACES Pain Rating Scale, and a Child Satisfaction Form at three time points-2 minutes prior to the test, immediately after the procedure, and at the 15th-minute post-test evaluation-through child, parent, and observer nurse assessments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study proposal outlines a randomized controlled trial (RCT) designed to investigate the effects of two non-pharmacological distraction techniques-watching cartoons and using a stress ball-on fear, anxiety, pain, and satisfaction levels in children aged 4 to 10 undergoing skin prick allergy testing at the Pediatric Allergy Outpatient Clinic of Çukurova University Balcalı Hospital between August 2026 and June 2027. A sample of 90 children undergoing their first allergy test without physical, visual, auditory, or cognitive impairments will be recruited based on power analysis calculations and randomly assigned via a computer program into three equal groups of 30: a cartoon-watching group, a stress ball group, and a control group receiving standard care with parent presence. The primary objective is to test the hypotheses ($H_1$ and $H_2$) that active or passive distraction significantly reduces procedural distress and enhances satisfaction, against the null hypothesis ($H_0$) of no effect. Data will be gathered using a Demographic Information Form, the Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-S), the Wong-Baker FACES Pain Rating Scale, and a Child Satisfaction Form. Assessments will be reported by the child, parent, and observer nurse at three specific timeline stages: 2 minutes prior to the test, immediately following the procedure while the child is in the procedure chair, and 15 minutes post-procedure during the evaluation of skin reactions. Ultimately, this research aims to establish evidence-based nursing interventions to improve pediatric comfort during invasive diagnostic procedures, with target outputs including presentations at national and international conferences and publication in SCI/SCI-Expanded indexed journals.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Tarsus, Turkey (Türkiye)
        • Recruiting
        • Tarsus University
        • Contact:
          • Atiye Karakul Assoc. Prof., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 4-10 years
  • Undergoing an allergy test for the first time
  • Voluntary participation by both the child and the parent

Exclusion Criteria:

  • The child must not have taken any medication prior to the skin test
  • The child must have a visual, hearing, or intellectual disability
  • The child must have a physical condition that would prevent them from using the stress ball

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cartoon-watching group
Children in this group will engage in passive distraction by watching cartoons.
Other: cartoon-watching group
Children in this group will engage in passive distraction by watching cartoons.
Experimental: stress ball group
Children in this group will engage in active physical distraction by using a stress ball.
Other: stress ball group
Children in this group will engage in active physical distraction by using a stress ball.
No Intervention: control group
Children in this group will receive the standard clinical care provided by the outpatient clinic without any specific non-pharmacological distraction interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain level
Time Frame: 1 hour
Wong Baker Pain Scale: It was developed by Donna Wong and Connie Morain Baker in 1980 and adapted again in 1983 to measure the pain levels of paediatric patients. There are 6 facial expressions scored between 0-5. In the Wong-Baker Scale, there are facial expressions indicating the degree of pain increasing from 0 to 5 from left to right.
1 hour
anxiety level
Time Frame: 1 hour
Child Anxiety Scale-Dispositional Scale (CAS-D): It was developed by Ersig et al. (2013) to measure the anxiety levels of children aged 4-10 years. The CAS-D scale is shaped like a thermometer with a light bulb at the bottom and horizontal lines with intervals going upwards. In this scale for children aged 4-10 years, children are asked 'Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer' or 'If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are'. In order to measure state anxiety (CAS-D), the child is asked to tick how he/she feels 'right now'. The score can range from 0-10.
1 hour
fear level
Time Frame: 1 hour
Child Fear Scale: The scale was developed by Thurillet et al. It was developed to evaluate children's fears based on self-report of children aged 4-12 years. The scale consists of six facial expressions. The scale grades fear with a score ranging from 0 to 10 (gradually graded two by two) consistent with pain rating scales. The first facial expression shows that there is no fear, the fear increases as you go from right to left, and the sixth facial expression shows that the level of fear is the highest. A statistically significant positive and very high correlation was obtained between the Fear Scale and the Child Fear Scale (r=0.973; p;0.001). The high correlation value between the two forms shows that the child form is valid.
1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
satisfaction level
Time Frame: 1 hour
The Child Satisfaction Scale was developed by researchers in line with the literature in a way that child patients can easily understand. The numbers between 0 and 10, which children will indicate by circling the point corresponding to their satisfaction with the education provided, are placed on a horizontal line. A score of 0 on the scale indicates "not satisfied at all" and a score of 10 indicates "extremely satisfied". In addition, there is a visual reflecting the degree of satisfaction in the places where the points are located.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tarsus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026/112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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