Inhalation Therapy; ComplicationsNCT05861232
The Effect of Watching Informative Animation on Fear and Anxiety in Children
A study testing Behavioral in people with Inhalation Therapy; Complications, run by Mukader Kaya at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. This project is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Inhalation Therapy; Complications
- What is being tested?
- Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2022to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child is 7-12 years of age
- The family's willingness to participate in the study
- The child's willingness to participate in the study
- The child does not have a chronic disease
Who cannot join
- The child has a chronic illness
- The child has a neurological or mental impairment
- The child is visually impaired
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Faculty of Nursing
Erzurum, Center, 25240
Mukader KAYA, WORK DIRECTOR, +905455853628, kader123300@gmail.com
About this study
Official title: THE EFFECT OF INFORMATIVE ANIMATION WATCHING ON ANXIETY AND FEAR DURING INHALATION THERAPY
The aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. This project is a randomized controlled trial. The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023. The sample of the study will consist of children and their parents who present to the clinic on the dates determined, who are willing to participate in the study, and meet the inclusion criteria. Probability sampling will be used to select the sample. ''Introductory Information Form'', ''Child Fear Scale'', ''Facial Expression Rating Scale'' and ''Informative Animation'' will be used for data collection.
Read the detailed description
Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:
The study will be conducted at Atatürk University Research Hospital Pediatric Emergency Department between July 2022 and July 2023.
Population and Sample of the Study: The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023.
- Conditions
- Inhalation Therapy; Complications
- Being tested
- Behavioral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralBehavioural
fear and anxiety during inhalation therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | informative animation, anxiety and fear Receives: Behavioral: Behavioral |
| No Intervention | No intervention | Control not anxiety and fear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale (CFS)
The Child Fear Scale was developed by McMurty et al. in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 Likert type scale showing five different faces, ranging from neutral (0 = no concern at all) to fearful (4 = severe anxiety).
Measured: 12 MONTHS
Secondary outcomes (1)
Facial Expressions Rating Scale
This visual facial scale is a practical method to assess the level of anxiety within a situation. There are six facial expressions, ranging from very happy to very unhappy, and children are asked to choose the one that comes closest to how they feel at that moment. The most positive face is scored as '0' and the most negative face is scored as '5'.
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start7 Jul 2022
- Primary completion7 Jul 2023 (estimated)
- Study completion7 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation Therapy; ComplicationsStudies of the same condition, open and under way.
- 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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mukader Kaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mukader Kaya, Ataturk University
- Investigators
- Mukader KAYA, graduate student, Principal investigator, ATATÜRK UNİVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861232
- Sponsor's protocol ID
- B.30.2.ATA.0.01.11/285
- Status last verified
- May 2023
- First submitted
- 11 Jan 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER PUBLICATION.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF INFORMATIVE ANIMATION WATCHING ON ANXIETY AND FEAR DURING INHALATION THERAPY
- ClinicalTrials.gov ID
- NCT05861232
- Acronym / sponsor ID
- B.30.2.ATA.0.01.11/285
- Conditions
- Inhalation Therapy; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mukader KayaUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 7 Jul 2023 (estimated)
- Study completion
- 7 Jul 2023 (estimated)
- First posted
- 16 May 2023 (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.
The aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. This project is a randomized controlled trial. The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023. The sample of the study will consist of children and their parents who present to the clinic on the dates determined, who are willing to participate in the study, and meet the inclusion criteria. Probability sampling will be used to select the sample. ''Introductory Information Form'', ''Child Fear Scale'', ''Facial Expression Rating Scale'' and ''Informative Animation'' will be used for data collection.
Detailed description
Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research:
The study will be conducted at Atatürk University Research Hospital Pediatric Emergency Department between July 2022 and July 2023.
Population and Sample of the Study: The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Behavioralinformative animation, anxiety and fear |
| No Intervention | No intervention | –Control not anxiety and fear |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child is 7-12 years of age
- The family's willingness to participate in the study
- The child's willingness to participate in the study
- The child does not have a chronic disease
Key exclusion criteria (3 listed)
- The child has a chronic illness
- The child has a neurological or mental impairment
- The child is visually impaired
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 |
|---|---|---|
| Behavioralfear and anxiety during inhalation therapy | Behavioural | Experimental |
Primary outcome
Child Fear Scale (CFS)
Time frame: 12 MONTHS
The Child Fear Scale was developed by McMurty et al. in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 Likert type scale showing five different faces, ranging from neutral (0 = no concern at all) to fearful (4 = severe anxiety).
1 secondary outcome
Facial Expressions Rating Scale
Time frame: 12 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER PUBLICATION.
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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. This study is not recruiting at the moment.
Mukader KAYA, graduate student principal investigator
ATATÜRK UNİVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral in people with Inhalation Therapy; Complications, run by Mukader Kaya 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mukader Kaya, graduate student (+905455853628, kader123300@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Fear Scale (CFS) (time frame: 12 MONTHS). 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 2 Jun 2023.