Therapeutic PlayNCT05415566
The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level
A study testing toy nebulizer and toy mask in people with Therapeutic Play and Anxiety, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was aimed to examine the effect of therapeutic play applied with a toy nebulizer and toy mask before inhaler treatment on children's fear and anxiety. It is the hypothesis of the study that the therapeutic play applied by using a toy mask and a toy nebulizer before inhaler treatment in children will… Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Play, Anxiety, Fear
- What is being tested?
- toy nebulizer and toy mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2021to 3 Jun 2022
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent and child volunteering to participate in the study,
- The child is between the ages of 3-8,
- Being admitted due to respiratory system disease,
- Inhaler treatment with a nebulizer will be applied.
Who cannot join
- Parent and child not voluntarily participating in the study,
- Intravenous, intramuscular or any other treatment request,
- The child has any genetic, congenital, chronic or metabolic disease,
- The child has vision, hearing and speech problems,
- The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, it was aimed to examine the effect of therapeutic play applied with a toy nebulizer and toy mask before inhaler treatment on children's fear and anxiety.
It is the hypothesis of the study that the therapeutic play applied by using a toy mask and a toy nebulizer before inhaler treatment in children will reduce the child's fear and anxiety.
Read the detailed description
Acute diseases constitute the majority of applications made to pediatric emergency services. Inhaled drugs are frequently used in the treatment of childhood acute respiratory system diseases. Nebulizers are the preferred method of administering inhaled drugs. Medical procedures are one of the biggest fears of children, making it difficult to use nebulizers correctly and effectively. The negative reaction of the child to the mask and nebulizer during inhaler treatment causes incorrect inhalation patterns, reducing the safety and effectiveness of the treatment. This causes difficulties in relieving symptoms, increased hospital admission and hospitalization time, more treatment costs, and even negative consequences such as increased morbidity.
Reducing the fear and anxiety seen in children due to the hospital environment and illness is important in terms of children's acceptance of the treatment process. One of the methods used for this purpose is therapeutic play. Pediatric nurses should fulfill their nursing roles and responsibilities by including therapeutic play in their care processes.
- Conditions
- Therapeutic Play, Anxiety, Fear
- Being tested
- toy nebulizer and toy mask
- Keywords
- Toy Mask, Toy Nebulizer, Child, Nurse
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toy nebulizer and toy maskCombination product
The treatment was administered using therapeutic play.
| Study group | Role | What they receive |
|---|---|---|
| Routine Treatment Group | No intervention | Inhaler treatment was applied according to the routine procedure in the emergency department. |
| Therapeutic Play Group | Experimental | Inhaler treatment was applied according to the "Therapeutic Play Guide" prepared by the researcher. Receives: Combination Product: toy nebulizer and toy mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the child's fear
Reducing the child's fear during inhaler treatment
Measured: during inhaler treatment
Reducing the child's anxiety
Reducing the child's anxiety during inhaler treatment
Measured: during inhaler treatment
Secondary outcomes (2)
Reducing the "Child Fear Scale" score
The Child Fear Scale (CFS) used. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. Scores range from 0 to 4.
Measured: shortly after inhaler treatment
Reducing the "Child Anxiety Scale-Stateness" score
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10.
Measured: shortly after inhaler treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start8 Feb 2021
- Primary completion31 Mar 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic PlayStudies of the same condition, open and under way.
- More trials run by Ege 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 population of the randomized controlled experimental study was composed of children aged 3-8 years who applied to the pediatric emergency department due to respiratory system disease.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Kahraman, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415566
- Sponsor's protocol ID
- 21116
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level
- ClinicalTrials.gov ID
- NCT05415566
- Acronym / sponsor ID
- 21116
- Conditions
- Therapeutic Play, Anxiety, Fear
- Keywords
- Toy Mask, Toy Nebulizer, Child, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 13 Jun 2022 (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.
In this study, it was aimed to examine the effect of therapeutic play applied with a toy nebulizer and toy mask before inhaler treatment on children's fear and anxiety.
It is the hypothesis of the study that the therapeutic play applied by using a toy mask and a toy nebulizer before inhaler treatment in children will reduce the child's fear and anxiety.
Detailed description
Acute diseases constitute the majority of applications made to pediatric emergency services. Inhaled drugs are frequently used in the treatment of childhood acute respiratory system diseases. Nebulizers are the preferred method of administering inhaled drugs. Medical procedures are one of the biggest fears of children, making it difficult to use nebulizers correctly and effectively. The negative reaction of the child to the mask and nebulizer during inhaler treatment causes incorrect inhalation patterns, reducing the safety and effectiveness of the treatment. This causes difficulties in relieving symptoms, increased hospital admission and hospitalization time, more treatment costs, and even negative consequences such as increased morbidity.
Reducing the fear and anxiety seen in children due to the hospital environment and illness is important in terms of children's acceptance of the treatment process. One of the methods used for this purpose is therapeutic play. Pediatric nurses should fulfill their nursing roles and responsibilities by including therapeutic play in their care processes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The population of the randomized controlled experimental study was composed of children aged 3-8 years who applied to the pediatric emergency department due to respiratory system disease.
| Arm | Type | Receives |
|---|---|---|
| Routine Treatment Group | No intervention | –Inhaler treatment was applied according to the routine procedure in the emergency department. |
| Therapeutic Play Group | Experimental | Combination Product: toy nebulizer and toy maskInhaler treatment was applied according to the "Therapeutic Play Guide" prepared by the researcher. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent and child volunteering to participate in the study,
- The child is between the ages of 3-8,
- Being admitted due to respiratory system disease,
- Inhaler treatment with a nebulizer will be applied.
Key exclusion criteria (5 listed)
- Parent and child not voluntarily participating in the study,
- Intravenous, intramuscular or any other treatment request,
- The child has any genetic, congenital, chronic or metabolic disease,
- The child has vision, hearing and speech problems,
- The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.
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 |
|---|---|---|
| toy nebulizer and toy maskThe treatment was administered using therapeutic play. | Combination product | Therapeutic Play Group |
Primary outcome
Reducing the child's fear
Time frame: during inhaler treatment
Reducing the child's fear during inhaler treatment
Reducing the child's anxiety
Time frame: during inhaler treatment
Reducing the child's anxiety during inhaler treatment
2 secondary outcomes
Reducing the "Child Fear Scale" score
Time frame: shortly after inhaler treatment
Reducing the "Child Anxiety Scale-Stateness" score
Time frame: shortly after inhaler treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing toy nebulizer and toy mask in people with Therapeutic Play and Anxiety, run by Ege 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing the child's fear (time frame: during inhaler treatment). The study lists 2 primary outcomes in all. 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 14 Jun 2022.