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The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's Anxiety, Fear, Psychological and Emotional Well-being

Primary Purpose

Child Mental Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Animal Assisted Practice
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Child Mental Disorder focused on measuring Animal Assisted Practice, Goldfish, Hospitalisation, Anxiety, Fear, Emotional Well-being, Psychological Well-being, Nursing

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bingöl Obstetrics and Pediatrics Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Animal Assisted Practice (Experimental) Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 25, 2021
Last Updated
March 29, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04775771
Brief Title
The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's Anxiety, Fear, Psychological and Emotional Well-being
Official Title
The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Mental Disorder
Keywords
Animal Assisted Practice, Goldfish, Hospitalisation, Anxiety, Fear, Emotional Well-being, Psychological Well-being, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Animal Assisted Practice (Experimental) Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Animal Assisted Practice
Intervention Description
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.
Primary Outcome Measure Information:
Title
The mean of STAI-1
Description
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.
Time Frame
Ten months
Secondary Outcome Measure Information:
Title
The mean of CFS
Description
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.
Time Frame
Ten months
Other Pre-specified Outcome Measures:
Title
The mean of SCWBS
Description
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.
Time Frame
Ten months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Bingöl Obstetrics and Pediatrics Hospital
City
Bingöl
ZIP/Postal Code
12000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Animal-assisted Practice Applied to Hospitalised Children on Children's Anxiety, Fear, Psychological and Emotional Well-being

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