- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04845100
Animal Assisted Activities on the Stress and Social Anxiety
The Effect of Animal Assisted Activities on the Stress and Social Anxiety Levels of Disabled Children
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
ANIMAL ASSISTED ACTIVITY PROGRAM (HayDAP):
- st week (Pre-test, introduction-introduction) Goal. Developing a trusting relationship
- nd week (Information about cats) Purpose: To strengthen the bond that develops between the child and the application animal
- th (Cat story reading) Purpose: To evaluate the emotions and solutions in the face of stressful life events in the face of the story.
- 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.
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
- 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
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Antalya, Turkey, 07210
- Şeyma Demiralay
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The Effect Of Animal Assisted Activities On The Stress And Social Anxiety Levels Of Disabled Children Animal Assisted Activity Program (HayDAP) |
Animal Assisted Activity Program (HayDAP)
|
Other: Control group
No intervention
|
Animal Assisted Activity Program (HayDAP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress
Time Frame: 7 Weeks, 1 Month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Anxiety
Time Frame: 7 Weeks, 1 Month
|
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
|
Blood Pressure
Time Frame: Only intervention group, every pre-intervention and post-intervention: During HayDAP intervention, for 7 weeks, before and after each application
|
Blodd Pressure
|
Only intervention group, every pre-intervention and post-intervention: During HayDAP intervention, for 7 weeks, before and after each application
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: İlkay KESER, Ass. Prof., Akdeniz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
Taichung Veterans General HospitalUnknown
Clinical Trials on Animal Assisted Activity Program
-
Norwegian University of Life SciencesCompleted
-
Atlas UniversityNot yet recruitingDepression | Loneliness | Old Age; Debility | Nursing Home | Loss of Interest in Activities
-
Norwegian University of Life SciencesVestfold University CollegeCompleted
-
Swiss Tropical & Public Health InstituteRehab Basel; University of BaselCompletedBrain Injuries | Consciousness DisorderSwitzerland
-
Washington State UniversityCompletedStress, Psychological | Stress, Physiological
-
University of Colorado, DenverPurdue University; Human Animal Bond Institute for ResearchCompletedAutism Spectrum Disorder | Child Behavior | Psychiatric Hospitalization | Veterinary Therapeutics
-
Universitair Ziekenhuis BrusselCompletedHospitalization in ChildrenBelgium
-
Swiss Tropical & Public Health InstituteRehab Basel; University of BaselRecruiting
-
Swiss Tropical & Public Health InstituteUniversity of Bern; Rehab Basel; University of BaselCompletedAcquired Brain InjurySwitzerland
-
Daniel Collado-MateoAsociación Dame La PataRecruitingWork Related Stress | Occupational GroupsSpain