- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04775771
The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's Anxiety, Fear, Psychological and Emotional Well-being
March 29, 2022 updated by: Abdullah Sarman, Inonu University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bingöl, Turkey, 12000
- Bingöl Obstetrics and Pediatrics Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Animal Assisted Practice (Experimental) Group
|
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.
|
No Intervention: Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Ten months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The mean of CFS
Time Frame: Ten months
|
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.
|
Ten months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The mean of SCWBS
Time Frame: Ten months
|
Stirling Children's Emotional and Psychological Well-being Scale (SCWBS): It is a scale developed to measure the emotional and psychological well-being levels of children between the ages of 8-15 and is graded between "never" (1 point) and "always" (5 points), consisting of 12 question items, in accordance with the 5-point Likert model.
There is no reverse item on the scale.
High scores from the scale indicate a high level of emotional and psychological well-being for children.
Item-total correlation coefficients of the scale were ranked between 0.57-0.73; the Cronbach-Alpha internal consistency coefficient was calculated as 0.90.
|
Ten months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
February 25, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
March 1, 2021
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/1166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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