NCT04845100

Brief Summary

ABSTRACT Objective: The aim of the study is to determine the effects of animal-assisted activities on the stress and social anxiety levels of physically disabled children. Method: The research was carried out in two separate Special Education and Rehabilitation Centers providing education under the Antalya Provincial Directorate of National Education. The data of the study were obtained between November 2019-September 2020. The study is a single blind randomized controlled study designed in a pretest, posttest and follow-up design. The study was carried out in two different institutions to prevent contamination. Institutions are determined by an independent lottery method. The sample of the study consisted of 44 physically disabled children between the ages of 8-11, as the intervention group (n: 21) and the control group (n: 23). A 45-60 minute structured animal supported activity program (HayDAP) was applied to the intervention group, once a week for 7 weeks. Interviews were conducted individually. The data of the study were obtained using Personal Information Form (KBF), Perceived Stress Scale (PSS) and Social Anxiety Scale for Children. Follow-up evaluation was made at the end of the 1st month following the completion of the application. There was no intervention in the control group. The data were analyzed using the Pearson Ki-Square Test in SPSS 23.0 package program, Fisher's Exact Test if large, Shapiro-Wilks Test, Box M, Bonferroni and mixed pattern ANOVA tests. A 95% significance level (or α = 0.05 margin of error) was used to determine the differences in the analyzes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

January 19, 2021

Last Update Submit

April 16, 2021

Conditions

Keywords

pet therapydisabled childstresssocial anxiety

Outcome Measures

Primary Outcomes (1)

  • Stress

    Perceived Stress Levell Scale; This one-dimensional scale consists of 9 items. It has a 4-point Likert type rating. The scores that can be obtained from the scale are between 9 and 36. The high scores on the scale questions indicate that the individual's stress level is means to be high.

    7 Weeks, 1 Month

Secondary Outcomes (2)

  • Social Anxiety

    7 Weeks, 1 Month

  • Blood Pressure

    Only intervention group, every pre-intervention and post-intervention: During HayDAP intervention, for 7 weeks, before and after each application

Study Arms (2)

Intervention

EXPERIMENTAL

The Effect Of Animal Assisted Activities On The Stress And Social Anxiety Levels Of Disabled Children Animal Assisted Activity Program (HayDAP)

Other: Animal Assisted Activity Program

Control group

OTHER

No intervention

Other: Animal Assisted Activity Program

Interventions

Animal Assisted Activity Program (HayDAP) 1. st week (Pre-test, introduction-introduction) 2. nd week (Information about cats) 3. th (Cat story reading) 4. th week (Teaching songs, poems, rhymes about cat) 5. th week (Making / decorating a cat house) 6. th week (Participation in the rehabilitation program with the treatment animal) 7. th week (Evaluation and closing, last test)

Control groupIntervention

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Volunteering to participate in research
  • Being in the age range of 8-11,
  • Only being physically disabled,
  • Reading and writing,
  • Parent's consent for the child to participate in the study

You may not qualify if:

  • Do not have an obstacle about the message
  • Being in any chronic disease with immune deficiency,
  • Don't have any animal allergies,
  • Application being afraid of animals,
  • Have an existing animal of your own, past or present
  • Extraction Criteria:
  • Not participating in the interview for more than 2 weeks,
  • Development of a medical condition that prevents communication,
  • Participant's right to withdraw from the research in line with his family or his own request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şeyma Demiralay

Antalya, 07210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Animal Communication

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • İlkay KESER, Ass. Prof.

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is a single blind randomized controlled study designed in a pretest, posttest and follow-up design.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate student

Study Record Dates

First Submitted

January 19, 2021

First Posted

April 14, 2021

Study Start

November 15, 2019

Primary Completion

November 15, 2020

Study Completion

November 15, 2020

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Animal Assisted Activity Program (HayDAP) 1. st week (Pre-test, introduction-introduction) 2. nd week (Information about cats) 3. th (Cat story reading) 4. th week (Teaching songs, poems, rhymes about cat) 5. th week (Making / decorating a cat house) 6. th week (Participation in the rehabilitation program with the treatment animal) 7. th week (Evaluation and closing, last test)

Locations