NCT05824624

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 28, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

May 20, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

March 28, 2023

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 hours

  • 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.

    2 hours

Study Arms (2)

study group

EXPERIMENTAL

Animal-supported application will be made to the children in the study group.

Other: ANIMAL-ASSISTED INTERVENTION

control group

EXPERIMENTAL

Routine care will be given to the children in the control group.

Other: Routine Care

Interventions

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.

study group

Routine nursing care will be provided.

control group

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, Eyalet/Yerleşke, 60200, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    PMID: 21806301BACKGROUND
  • 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

    RESULT

MeSH Terms

Conditions

Disease Models, AnimalEmergencies

Condition Hierarchy (Ancestors)

Animal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mukaddes Demir Acar

    Tokat Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mukaddes Demir Acar, DR

CONTACT

Gülmelek Yılmaz, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 21, 2023

Study Start

May 20, 2023

Primary Completion

October 1, 2023

Study Completion

January 15, 2024

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations