Back to resultsThe Effect Of Animal-Assisted Intervention
Primary Purpose
Animal Model, Pediatric, Emergencies
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ANIMAL-ASSISTED INTERVENTION
Routine Care
Sponsored by
About this trial
This is an interventional supportive care trial for Animal Model
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Tokat Gaziosmanpasa University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
control group
Arm Description
Animal-supported application will be made to the children in the study group.
Routine care will be given to the children in the control group.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05824624
First Posted
March 28, 2023
Last Updated
April 20, 2023
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT05824624
Brief Title
The Effect Of Animal-Assisted Intervention
Official Title
The Effect Of Animal-Assisted Intervention On Fear In Hospıtalızed Children In The Emergency Department: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Animal Model, Pediatric, Emergencies, Fear, Nursing Caries
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled experimental model
Masking
Participant
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Animal-supported application will be made to the children in the study group.
Arm Title
control group
Arm Type
Experimental
Arm Description
Routine care will be given to the children in the control group.
Intervention Type
Other
Intervention Name(s)
ANIMAL-ASSISTED INTERVENTION
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Care
Intervention Description
Routine nursing care will be provided.
Primary Outcome Measure Information:
Title
The Scale Development of Fear in Children Against Nursing Interventions and Used Materıals
Description
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.
Time Frame
2 hours
Title
Child Fear Scale
Description
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.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mukaddes Demir Acar, DR
Phone
+905055790222
Email
mukaddesdemir.acar@gop.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Gülmelek Yılmaz, RN
Phone
5067340746
Email
gulmelek.yilmaz@gop.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukaddes Demir Acar
Organizational Affiliation
Tokat Gaziosmanpasa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tokat Gaziosmanpasa University
City
Tokat
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
60200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
21806301
Citation
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.
Results Reference
background
Citation
Eren 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
Results Reference
result
Learn more about this trial
The Effect Of Animal-Assisted Intervention
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