Animal Assisted Activities on the Stress and Social Anxiety

April 16, 2021 updated by: Şeyma Demiralay

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07210
        • Şeyma Demiralay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention

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

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)
Other: Control group
No intervention
Other: Animal Assisted Activity Program

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Şeyma Demiralay

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: İlkay KESER, Ass. Prof., Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 013 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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