Animal ModelNCT05824624
The Effect Of Animal-Assisted Intervention
A study testing ANIMAL-ASSISTED INTERVENTION and Routine Care in people with Animal Model and Pediatric, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the effect of animal-assisted practice on fear in children admitted to the emergency room. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Animal Model, Pediatric, Emergencies
- What is being tested?
- ANIMAL-ASSISTED INTERVENTION and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2023to 15 Jan 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be followed for at least 2 hours in the pediatric emergency room,
- Age range is 5-7,
- Not afraid of the goldfish to be used in the research,
- Not allergic to fish and fish feed,
- Does not have physical, auditory, visual and cognitive barriers to feeding (feeding),
- No speech or communication disorder that will prevent the parent and child from communicating,
- Parent and child's willingness to participate in the research
Who cannot join
- Patients who are not admitted to the Pediatric Emergency room, patients who do not fit the age range of 5-7, who stay less than 2 hours,
- Afraid of goldfish, allergic to fish food, preventing feeding, having physical, auditory, visual and cognitive disabilities,
- Patients with speech and communication disorders that will prevent parents and children from communicating,
- Parent and child not willing to participate in the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Eyalet/Yerleşke, 60200
About this study
Official title: The Effect Of Animal-Assisted Intervention On Fear In Hospıtalızed Children In The Emergency Department: A Randomized Controlled Study
The aim of the study is to examine the effect of animal-assisted practice on fear in children admitted to the emergency room.
Read the detailed description
Children's fears about the hospital are traumatic and confront us as a hindering factor in their growth and development.Bringing the child to the emergency room and not knowing what will happen there creates great fear in him. Children already have different fears according to different age groups and developmental stages. These; separation from family, pain and suffering, change in body image (losing body parts), etc. The state of fear can lead to a worsening of the child's existing illness and symptoms. In addition to being separated from the family, being separated from peers, not being able to play games, staying away from school if going to school, etc. they have concerns.
- Conditions
- Animal Model, Pediatric, Emergencies, Fear, Nursing Caries
- Being tested
- ANIMAL-ASSISTED INTERVENTION, Routine Care
- Medical subject headings
- Disease Models, Animal, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANIMAL-ASSISTED INTERVENTIONOther
It will be ensured that the child is introduced to the goldfish when he is lying in the observation room, that the child will name the fish, and that he will communicate and feed the fish during his stay. Thus, it is aimed to turn the attention of the child to the goldfish while in the emergency room, to distract the child with the fish while all nursing interventions are presented, and to reduce the fear.
Routine CareOther
Routine nursing care will be provided.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Animal-supported application will be made to the children in the study group. Receives: Other: ANIMAL-ASSISTED INTERVENTION |
| control group | Experimental | Routine care will be given to the children in the control group. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Scale Development of Fear in Children Against Nursing Interventions and Used Materıals
The scale was created to develop a valid and reliable measurement tool for children to determine their fear of nursing interventions and used materials. As a result of the validity and reliability analyzes of the scale, it was composed of 18 items. The scale has 2 sub-dimensions. These are fear of common materials (10 items) and fear of uncommon materials (8 items). The scale was scored as (1) not afraid, (2) little afraid, (3) afraid, (4) very afraid, (5) extremely afraid.
Measured: 2 hours
Child Fear Scale
The Scale is a scale consisting of the display of five drawn facial expressions, ranging from neutral expression (0 points) to "no fear" to frightened face (4 points) to "severe fear". The scale is intended for children aged 5-10 years.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start20 May 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Animal ModelStudies 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
- Randomized controlled experimental model
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mukaddes Demir Acar, Tokat Gaziosmanpasa University
- Investigators
- Mukaddes Demir Acar, Principal investigator, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824624
- Sponsor's protocol ID
- DEMIRACAR
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Özalp Gerçeker, G., Ayar, D., Özdemir, Z., & Bektaş, M. 2018. Gaining of Children's State Anxiety and Children's Fear Scale to Turkish Language. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13.
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Eren Kok H, Orsal O. The Development of a Scale to Measure Children's Fear of Nursing Interventions and Instruments Used in Hospital. Psychiatry and Behavioral Sciences 2023;13(1):47-56. Doi: 10.5455/PBS.20221101060619
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Animal-Assisted Intervention On Fear In Hospıtalızed Children In The Emergency Department: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05824624
- Acronym / sponsor ID
- DEMIRACAR
- Conditions
- Animal Model, Pediatric, Emergencies, Fear, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 21 Apr 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 the study is to examine the effect of animal-assisted practice on fear in children admitted to the emergency room.
Detailed description
Children's fears about the hospital are traumatic and confront us as a hindering factor in their growth and development.Bringing the child to the emergency room and not knowing what will happen there creates great fear in him. Children already have different fears according to different age groups and developmental stages. These; separation from family, pain and suffering, change in body image (losing body parts), etc. The state of fear can lead to a worsening of the child's existing illness and symptoms. In addition to being separated from the family, being separated from peers, not being able to play games, staying away from school if going to school, etc. they have concerns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled experimental model
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: ANIMAL-ASSISTED INTERVENTIONAnimal-supported application will be made to the children in the study group. |
| control group | Experimental | Other: Routine CareRoutine care will be given to the children in the control group. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- To be followed for at least 2 hours in the pediatric emergency room,
- Age range is 5-7,
- Not afraid of the goldfish to be used in the research,
- Not allergic to fish and fish feed,
- Does not have physical, auditory, visual and cognitive barriers to feeding (feeding),
Key exclusion criteria (4 listed)
- Patients who are not admitted to the Pediatric Emergency room, patients who do not fit the age range of 5-7, who stay less than 2 hours,
- Afraid of goldfish, allergic to fish food, preventing feeding, having physical, auditory, visual and cognitive disabilities,
- Patients with speech and communication disorders that will prevent parents and children from communicating,
- Parent and child not willing to participate in the research.
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 |
|---|---|---|
| ANIMAL-ASSISTED INTERVENTIONIt will be ensured that the child is introduced to the goldfish when he is lying in the observation room, that the child will name the fish, and that he will communicate and feed the fish during his stay. Thus, it is aimed to turn the attention of the child to the goldfish while in the emergency room, to distract the child with the fish while all nursing interventions are presented, and to reduce the fear. | Other | study group |
| Routine CareRoutine nursing care will be provided. | Other | control group |
Primary outcome
The Scale Development of Fear in Children Against Nursing Interventions and Used Materıals
Time frame: 2 hours
The scale was created to develop a valid and reliable measurement tool for children to determine their fear of nursing interventions and used materials. As a result of the validity and reliability analyzes of the scale, it was composed of 18 items. The scale has 2 sub-dimensions. These are fear of common materials (10 items) and fear of uncommon materials (8 items). The scale was scored as (1) not afraid, (2) little afraid, (3) afraid, (4) very afraid, (5) extremely afraid.
Child Fear Scale
Time frame: 2 hours
The Scale is a scale consisting of the display of five drawn facial expressions, ranging from neutral expression (0 points) to "no fear" to frightened face (4 points) to "severe fear". The scale is intended for children aged 5-10 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- BackgroundÖzalp Gerçeker, G., Ayar, D., Özdemir, Z., & Bektaş, M. 2018. Gaining of Children's State Anxiety and Children's Fear Scale to Turkish Language. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13.
- Background: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Results publicationEren Kok H, Orsal O. The Development of a Scale to Measure Children's Fear of Nursing Interventions and Instruments Used in Hospital. Psychiatry and Behavioral Sciences 2023;13(1):47-56. Doi: 10.5455/PBS.20221101060619
- 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.
Mukaddes Demir Acar principal investigator
Tokat Gaziosmanpasa 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 ANIMAL-ASSISTED INTERVENTION and Routine Care in people with Animal Model and Pediatric, run by Tokat Gaziosmanpasa 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 7 inclusion and 4 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 21 Apr 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 Mukaddes Demir Acar, DR (+905055790222, mukaddesdemir.acar@gop.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Scale Development of Fear in Children Against Nursing Interventions and Used Materıals (time frame: 2 hours). 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?
On the ClinicalTrials.gov record for NCT05824624, which also lists 3 linked publications.
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 21 Apr 2023.