Hospitalism in ChildrenNCT06162598
The Ventriloquist Puppet Method for Children Under The Inhaler Treatment
A study testing Ventriloquist Puppet in people with Hospitalism in Children, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on anxiety and fear level of children aged 4-6 Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Hospitalism in Children
- What is being tested?
- Ventriloquist Puppet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2023to 15 Jul 2024
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 4-6,
- Children receiving inhaler therapy,
- Children and families who can speak Turkish,
- Children and families who volunteer to participate in the research,
Who cannot join
- Children with cognitive or mental problems,
- Children with life-threatening conditions,
- Children with hearing, vision and/or speech impairments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tuba ARPACI
Karaman, 70200
Tuba ARPACI, Phd, +905306401928, tubaarpaci25@gmail.com
Merve Akar, +905372945961, merveakar555@gmail.com
About this study
Official title: The Effect of Preparation With The Ventriloquist Puppet Method Before Inhaler Treatment on Anxiety and Fear Level of Children Aged 4-6
This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on anxiety and fear level of children aged 4-6
Read the detailed description
Although treatment methods appropriate to the disease are applied in respiratory system diseases, healthcare professionals must cooperate with the child and family regarding compliance with the treatment (oral, nebulizer, inhaler) and management of the disease. Children may experience anxiety and fear from the moment they enter the hospital. They may react to being in the hospital and medical procedures such as crying, running away, or withdrawing. Age, previous negative hospitalization experiences, and fear of getting sick are factors that shape children's medical fears. The majority of children have 'a little' or 'a lot' of fear about medical procedures. Children have adaptation problems to the inhaler treatment and often reject it. To provide effective treatment, compliance of the child and family with the treatment and suitable application techniques are crucial. In this process, it is important to minimize the anxiety and fear of children and ensure that they receive the treatment in the best possible way. Therapeutic approaches such as distraction cards, musical toys, and puppets during the preparation of the child for the procedure before the treatment can increase the child's compliance with the treatment and reduce the level of anxiety. In a study, puppet shows were useful in reducing the fears of children with 'a lot' fear. In another study, finger puppets as a play enhanced communication with children with cancer and were suitable for use in the hospital environment. It has been concluded that the use of puppets is beneficial because it gives children the opportunity to express themselves freely. An effort should be made to reduce the child's anxiety and fear by taking a therapeutic approach not only for invasive procedures but also for non-invasive procedures. Therapeutic approaches can be applied to the child and family before, during, and after treatment. This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on the anxiety and fear levels of children aged 4-6.
- Conditions
- Hospitalism in Children
- Being tested
- Ventriloquist Puppet
- Keywords
- Children, Nursing, Puppet, Ventriloquist, Inhaler treatment, Therapeutic approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventriloquist PuppetOther
one day preparation intervention applied by researcher for children under the inhaler treatment. Preparation will be 30 minutes long
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Children in the control group will undergo the routine preparation procedure applied in the emergency department. Before and after inhaler treatment, the child, parent, and nurse will be asked to fill out data collection forms to assess the child's anxiety and fear levels. |
| Ventriloquist Puppet group | Experimental | The preparation for the procedure will be accompanied by a puppet before the treatment. The child will be told about the features of the puppet and will be introduced to it. The inhaler treatment application will be explained to the intervention group through the ventriloquist puppet method. By making the puppet talk using the ventriloquism technique, the child will be able to understand the procedure. The application of the inhaler will be shown to the child with the help of a nebulizer mask on the puppet. Before the application and after the inhaler treatment, the child, parent, and nurse will be asked to fill out the children's state anxiety scale and children's fear scale to evaluate the child's anxiety and fear levels. Receives: Other: Ventriloquist Puppet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Children's State Anxiety Scale: Validated scale used for evaluation of 4-10 aged children's anxiety level. Scale score ranges between 0-10
Measured: one day
Fear
Children's Fear Scale: Validated scale used for evaluation of 5-10 aged children's fear level. Scale score ranges between 0-4.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start12 Aug 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalism in ChildrenStudies 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
- Two group with conventional therapy control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Arpacı, Karamanoğlu Mehmetbey University
- Investigators
- Tuba ARPACI, PhD, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162598
- Sponsor's protocol ID
- KMU-SBF-TA-02
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preparation With The Ventriloquist Puppet Method Before Inhaler Treatment on Anxiety and Fear Level of Children Aged 4-6
- ClinicalTrials.gov ID
- NCT06162598
- Acronym / sponsor ID
- KMU-SBF-TA-02
- Conditions
- Hospitalism in Children
- Keywords
- Children, Nursing, Puppet, Ventriloquist, Inhaler treatment, Therapeutic approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 8 Dec 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.
This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on anxiety and fear level of children aged 4-6
Detailed description
Although treatment methods appropriate to the disease are applied in respiratory system diseases, healthcare professionals must cooperate with the child and family regarding compliance with the treatment (oral, nebulizer, inhaler) and management of the disease. Children may experience anxiety and fear from the moment they enter the hospital. They may react to being in the hospital and medical procedures such as crying, running away, or withdrawing. Age, previous negative hospitalization experiences, and fear of getting sick are factors that shape children's medical fears. The majority of children have 'a little' or 'a lot' of fear about medical procedures. Children have adaptation problems to the inhaler treatment and often reject it. To provide effective treatment, compliance of the child and family with the treatment and suitable application techniques are crucial. In this process, it is important to minimize the anxiety and fear of children and ensure that they receive the treatment in the best possible way. Therapeutic approaches such as distraction cards, musical toys, and puppets during the preparation of the child for the procedure before the treatment can increase the child's compliance with the treatment and reduce the level of anxiety. In a study, puppet shows were useful in reducing the fears of children with 'a lot' fear. In another study, finger puppets as a play enhanced communication with children with cancer and were suitable for use in the hospital environment. It has been concluded that the use of puppets is beneficial because it gives children the opportunity to express themselves freely. An effort should be made to reduce the child's anxiety and fear by taking a therapeutic approach not only for invasive procedures but also for non-invasive procedures. Therapeutic approaches can be applied to the child and family before, during, and after treatment. This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on the anxiety and fear levels of children aged 4-6.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two group with conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Children in the control group will undergo the routine preparation procedure applied in the emergency department. Before and after inhaler treatment, the child, parent, and nurse will be asked to fill out data collection forms to assess the child's anxiety and fear levels. |
| Ventriloquist Puppet group | Experimental | Other: Ventriloquist PuppetThe preparation for the procedure will be accompanied by a puppet before the treatment. The child will be told about the features of the puppet and will be introduced to it. The inhaler treatment application will be explained to the intervention group through the ventriloquist puppet method. By making the puppet talk using the ventriloquism technique, the child will be able to understand the procedure. The application of the inhaler will be shown to the child with the help of a nebulizer mask on the puppet. Before the application and after the inhaler treatment, the child, parent, and nurse will be asked to fill out the children's state anxiety scale and children's fear scale to evaluate the child's anxiety and fear levels. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 4-6,
- Children receiving inhaler therapy,
- Children and families who can speak Turkish,
- Children and families who volunteer to participate in the research,
Key exclusion criteria (3 listed)
- Children with cognitive or mental problems,
- Children with life-threatening conditions,
- Children with hearing, vision and/or speech impairments
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 |
|---|---|---|
| Ventriloquist Puppetone day preparation intervention applied by researcher for children under the inhaler treatment. Preparation will be 30 minutes long | Other | Ventriloquist Puppet group |
Primary outcome
Anxiety
Time frame: one day
Children's State Anxiety Scale: Validated scale used for evaluation of 4-10 aged children's anxiety level. Scale score ranges between 0-10
Fear
Time frame: one day
Children's Fear Scale: Validated scale used for evaluation of 5-10 aged children's fear level. Scale score ranges between 0-4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- 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.
Tuba ARPACI, PhD principal investigator
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventriloquist Puppet in people with Hospitalism in Children, run by Karamanoğlu Mehmetbey 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 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 6 Mar 2024. 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 Tuba ARPACI, PhD (+905306401928, tubaarpaci25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: one day). 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 6 Mar 2024.