Child Mental DisorderNCT04775771
The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's Anxiety, Fear, Psychological and Emotional Well-being
A study testing Animal Assisted Practice in people with Child Mental Disorder, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
In the normal development stage, children become ill for various reasons and maybe hospitalised. Illnesses and hospitalization are major sources of stress for any growing child. In addition to being admitted to the hospital, unknown environment, unknown people in this environment, unknown equipment, scary voices… Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Mental Disorder
- What is being tested?
- Animal Assisted Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 31 Aug 2021
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being 8 years old and over, 10 years old or younger,
- Hospitalization due to an acute illness,
- Not afraid of aquarium fish to be used in practice,
- Not being allergic to fish and fish food,
- Not having physical, auditory, visual, and cognitive disabilities that would prevent the aquarium fish from feeding twice daily and in the aquarium within the scope of HDU,
- Staying in the pediatric clinic for three days,
- Not having a speech disorder that will prevent them from communicating.
Who cannot join
- Having a physical, auditory, visual, and cognitive disability that prevents the aquarium fish from feeding twice daily,
- Afraid of goldfish,
- Being allergic to fish and eating.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bingöl Obstetrics and Pediatrics Hospital
Bingoel, 12000
About this study
Official title: The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's
In the normal development stage, children become ill for various reasons and maybe hospitalised. Illnesses and hospitalization are major sources of stress for any growing child. In addition to being admitted to the hospital, unknown environment, unknown people in this environment, unknown equipment, scary voices, thought of physical harm, fears such as separation from the family, etc. Different degrees of stress occur for reasons. In addition to these, children face many problems related to physical limitations caused by hospitalization due to illness, and they experience negative emotions such as anxiety, fear, and anxiety. On the day the child is admitted to the hospital, the child and his family experience high levels of anxiety. Children's anxiety and fear may negatively affect their ability to understand the explanations to be made correctly, to interpret events realistically, to make appropriate decisions, and to participate in care. Various treatment methods such as therapeutic games, art therapy, drawing, occupational therapy, animal-assisted practices/activities (HDU) are applied in the hospital environment to improve the child's coping skills and to reduce negative emotions such as pain, anxiety, stress, and fear. The animal-assisted practice is activities that offer various opportunities to improve the quality of life and provide entertainment and therapeutic benefits. Although the use of animal-assisted applications is widespread abroad, its use in our country and the rate of reflection on the results of the study is quite limited. In the researches, interaction with such animals; has been determined to be psychologically, emotionally, socially, and physically supportive in children. It is planned to use goldfish in this study. Aquarium fish is one of the ornamental fish sold in more than 125 countries and more than 2500 species globally. No study has been conducted on the effects of aquarium fish, which are reported to have positive effects and provide calming when applied with adult age groups within the scope of animal-assisted practices, on anxiety, fear, psychological and emotional well-being in children treated in a clinical setting. This study will be conducted to examine the effects of animal-assisted practice on anxiety, fear, the psychological and emotional well-being of children hospitalised.
- Conditions
- Child Mental Disorder
- Being tested
- Animal Assisted Practice
- Keywords
- Animal Assisted Practice, Goldfish, Hospitalisation, Anxiety, Fear, Emotional Well-being, Psychological Well-being, Nursing
- Medical subject headings
- Neurodevelopmental Disorders, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted PracticeBehavioural
The children, who were planned to be hospitalized for at least three days and were randomized to the experimental and control groups, were asked by the researcher using the face-to-face interview technique, and the questions in the patient information form were filled in on the form. Then, pre-test data were recorded by determining their anxiety levels with the State Anxiety Scale for Children, levels of fear with the Child Fear Scale, emotional and psychological well-being with the Stirling Children's Emotional and Psychological Well-being Scale. Unlike the other scales, the anxiety levels were assessed twice with one-hour intervals on the first day with the Children's State Anxiety Scale. On the third day, the anxiety levels were evaluated twice with one-hour intervals on the first day using the State Anxiety Scale for Children. The second group, the children in the control group, had the same procedure except for the intervention; but no intervention was made.
| Study group | Role | What they receive |
|---|---|---|
| Animal Assisted Practice (Experimental) Group | Experimental | Not described Receives: Behavioral: Animal Assisted Practice |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean of STAI-1
The State Anxiety Inventory for Children (STAI-1): It consists of 20 items scored from 1 to 3 according to the severity and the scores to be obtained from the scale data range between 20 and 60. The Cronbach-Alpha value of the scale was found to be 0.82. Although the validity and reliability study of the scale has been conducted on children aged 9-12, it is also used in children between the ages of 7-17.
Measured: Ten months
Secondary outcomes (1)
The mean of CFS
The Child Fear Scale (CFS): It is a scale consisting of showing five drawn facial expressions ranging from neutral expression (0 points) to "no fear", to a frightened face (4 points) "severe fear". The scale is intended for children aged 5-10 years.
Measured: Ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Nov 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Mental DisorderStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Sarman, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775771
- Sponsor's protocol ID
- 2020/1166
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2021
- Last updated
- 31 Mar 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's
- ClinicalTrials.gov ID
- NCT04775771
- Acronym / sponsor ID
- 2020/1166
- Conditions
- Child Mental Disorder
- Keywords
- Animal Assisted Practice, Goldfish, Hospitalisation, Anxiety, Fear, Emotional Well-being, Psychological Well-being, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 1 Mar 2021 (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 the normal development stage, children become ill for various reasons and maybe hospitalised. Illnesses and hospitalization are major sources of stress for any growing child. In addition to being admitted to the hospital, unknown environment, unknown people in this environment, unknown equipment, scary voices, thought of physical harm, fears such as separation from the family, etc. Different degrees of stress occur for reasons. In addition to these, children face many problems related to physical limitations caused by hospitalization due to illness, and they experience negative emotions such as anxiety, fear, and anxiety. On the day the child is admitted to the hospital, the child and his family experience high levels of anxiety. Children's anxiety and fear may negatively affect their ability to understand the explanations to be made correctly, to interpret events realistically, to make appropriate decisions, and to participate in care. Various treatment methods such as therapeutic games, art therapy, drawing, occupational therapy, animal-assisted practices/activities (HDU) are applied in the hospital environment to improve the child's coping skills and to reduce negative emotions such as pain, anxiety, stress, and fear. The animal-assisted practice is activities that offer various opportunities to improve the quality of life and provide entertainment and therapeutic benefits. Although the use of animal-assisted applications is widespread abroad, its use in our country and the rate of reflection on the results of the study is quite limited. In the researches, interaction with such animals; has been determined to be psychologically, emotionally, socially, and physically supportive in children. It is planned to use goldfish in this study. Aquarium fish is one of the ornamental fish sold in more than 125 countries and more than 2500 species globally. No study has been conducted on the effects of aquarium fish, which are reported to have positive effects and provide calming when applied with adult age groups within the scope of animal-assisted practices, on anxiety, fear, psychological and emotional well-being in children treated in a clinical setting. This study will be conducted to examine the effects of animal-assisted practice on anxiety, fear, the psychological and emotional well-being of children hospitalised.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animal Assisted Practice (Experimental) Group | Experimental | Behavioral: Animal Assisted Practice |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Being 8 years old and over, 10 years old or younger,
- Hospitalization due to an acute illness,
- Not afraid of aquarium fish to be used in practice,
- Not being allergic to fish and fish food,
- Not having physical, auditory, visual, and cognitive disabilities that would prevent the aquarium fish from feeding twice daily and in the aquarium within the scope of HDU,
Key exclusion criteria (3 listed)
- Having a physical, auditory, visual, and cognitive disability that prevents the aquarium fish from feeding twice daily,
- Afraid of goldfish,
- Being allergic to fish and eating.
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 PracticeThe children, who were planned to be hospitalized for at least three days and were randomized to the experimental and control groups, were asked by the researcher using the face-to-face interview technique, and the questions in the patient information form were filled in on the form. Then, pre-test data were recorded by determining their anxiety levels with the State Anxiety Scale for Children, levels of fear with the Child Fear Scale, emotional and psychological well-being with the Stirling Children's Emotional and Psychological Well-being Scale. Unlike the other scales, the anxiety levels were assessed twice with one-hour intervals on the first day with the Children's State Anxiety Scale. On the third day, the anxiety levels were evaluated twice with one-hour intervals on the first day using the State Anxiety Scale for Children. The second group, the children in the control group, had the same procedure except for the intervention; but no intervention was made. | Behavioural | Animal Assisted Practice (Experimental) Group |
Primary outcome
The mean of STAI-1
Time frame: Ten months
The State Anxiety Inventory for Children (STAI-1): It consists of 20 items scored from 1 to 3 according to the severity and the scores to be obtained from the scale data range between 20 and 60. The Cronbach-Alpha value of the scale was found to be 0.82. Although the validity and reliability study of the scale has been conducted on children aged 9-12, it is also used in children between the ages of 7-17.
1 secondary outcome
The mean of CFS
Time frame: Ten months
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 31 Mar 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 Animal Assisted Practice in people with Child Mental Disorder, run by Inonu 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 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: finished, as of the sponsor's last update on 31 Mar 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?
The mean of STAI-1 (time frame: Ten 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 31 Mar 2022.