Stress Clinical Trial
Official title:
The Effect of Animal Assisted Activities on the Stress and Social Anxiety Levels of Disabled Children
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 |
Verified date | April 2021 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Seyma Demiralay | Antalya |
Lead Sponsor | Collaborator |
---|---|
Seyma Demiralay |
Turkey,
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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