NCT04775771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

February 25, 2021

Last Update Submit

March 29, 2022

Conditions

Keywords

Animal Assisted PracticeGoldfishHospitalisationAnxietyFearEmotional Well-beingPsychological Well-beingNursing

Outcome Measures

Primary Outcomes (1)

  • 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.

    Ten months

Secondary Outcomes (1)

  • The mean of CFS

    Ten months

Other Outcomes (1)

  • The mean of SCWBS

    Ten months

Study Arms (2)

Animal Assisted Practice (Experimental) Group

EXPERIMENTAL
Behavioral: Animal Assisted Practice

Control Group

NO INTERVENTION

Interventions

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.

Animal Assisted Practice (Experimental) Group

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bingöl Obstetrics and Pediatrics Hospital

Bingöl, 12000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neurodevelopmental DisordersAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

November 1, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations