StressNCT04845100
Animal Assisted Activities on the Stress and Social Anxiety
A study testing Animal Assisted Activity Program in people with Stress and Social Anxiety, run by Şeyma Demiralay at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Social Anxiety, Disabling Disease
- What is being tested?
- Animal Assisted Activity Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2019to 15 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Stress, Social Anxiety, Disabling Disease, Animal Communication, Nursing Caries, Child
- Being tested
- Animal Assisted Activity Program
- Keywords
- pet therapy, disabled child, stress, social anxiety
- Medical subject headings
- Animal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted Activity ProgramOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Effect Of Animal Assisted Activities On The Stress And Social Anxiety Levels Of Disabled Children
Animal Assisted Activity Program (HayDAP) Receives: Other: Animal Assisted Activity Program |
| Control group | Other | No intervention Receives: Other: Animal Assisted Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 Weeks, 1 Month
Secondary outcomes (2)
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.
Measured: 7 Weeks, 1 Month
Blood Pressure
Blodd Pressure
Measured: Only intervention group, every pre-intervention and post-intervention: During HayDAP intervention, for 7 weeks, before and after each application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start15 Nov 2019
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a single blind randomized controlled study designed in a pretest, posttest and follow-up design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şeyma Demiralay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şeyma Demiralay, Akdeniz University
- Investigators
- İlkay KESER, Ass. Prof., Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845100
- Sponsor's protocol ID
- 013
- Status last verified
- Apr 2021
- First submitted
- 19 Jan 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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)
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animal Assisted Activities on the Stress and Social Anxiety Levels of Disabled Children
- ClinicalTrials.gov ID
- NCT04845100
- Acronym / sponsor ID
- 013
- Conditions
- Stress, Social Anxiety, Disabling Disease, Animal Communication, Nursing Caries, Child
- Keywords
- pet therapy, disabled child, stress, social anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Şeyma DemiralayUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a single blind randomized controlled study designed in a pretest, posttest and follow-up design.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Animal Assisted Activity ProgramThe Effect Of Animal Assisted Activities On The Stress And Social Anxiety Levels Of Disabled Children Animal Assisted Activity Program (HayDAP) |
| Control group | Other | Other: Animal Assisted Activity ProgramNo intervention |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal Assisted Activity ProgramAnimal 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, Intervention |
Primary outcome
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.
2 secondary outcomes
Social Anxiety
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlkay KESER, Ass. Prof. study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Activity Program in people with Stress and Social Anxiety, run by Şeyma Demiralay at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: 7 Weeks, 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.