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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04845100
Other study ID # 013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date November 15, 2020

Study information

Verified date April 2021
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

ANIMAL ASSISTED ACTIVITY PROGRAM (HayDAP): 1. st week (Pre-test, introduction-introduction) Goal. Developing a trusting relationship 2. nd week (Information about cats) Purpose: To strengthen the bond that develops between the child and the application animal 3. th (Cat story reading) Purpose: To evaluate the emotions and solutions in the face of stressful life events in the face of the story. 4. th week (Teaching songs, poems, rhymes about cat) Objective: To determine the factors that may cause social anxiety and to support the increase of self-confidence in the child. 5. th week (Making / decorating a cat house) Purpose: Discussing the roles and relationships of the child in his / her social environment and developing awareness with examples of cats. Improving communication and problem solving skills 6. th week (Participation in the rehabilitation program with the treatment animal) Purpose: To monitor the child's adherence to treatment Evaluating the child's compliance with the treatment during physiotherapy activities while being observed by the application cat and the practitioner 7. th week (Evaluation and closing, last test) Purpose: Finishing the whole process by passing A healthy termination of the bond formed with the practice cat


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 15, 2020
Est. primary completion date November 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 11 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

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

Locations

Country Name City State
Turkey Seyma Demiralay Antalya

Sponsors (1)

Lead Sponsor Collaborator
Seyma Demiralay

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Social Anxiety Social Anxiety Scale for Children-Revised; This one-dimensional scale has a 5-point Likert-type scale consisting of 18 items.
The scores that can be obtained from the scale are between 18 and 90.
The higher the score, the higher the social anxiety level.
7 Weeks, 1 Month
Secondary Blood Pressure Blodd Pressure Only intervention group, every pre-intervention and post-intervention: During HayDAP intervention, for 7 weeks, before and after each application
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