- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07512180
The Effect of Animal-Assisted Activity Programme Based on Human Caring Theory on Perceived Stress, Social Adaptation and Communication Skills of Children With Speech and Language Disorders
Animal-Assisted Activity Programme Based on Human Caring Theory With Speech and Language Disorders
Animal-assisted practice is an intervention method explained with different mechanisms and theories that provides protection and development of health through human-animal interaction. Animal-assisted practices can be applied to children, adults, elderly, healthy or sick individuals of all ages. Children are among the most commonly used groups. Studies conducted with children have indicated that animal-assisted practices facilitate the expression of emotions, improve health perception, increase communication skills, desire to continue school, increase adaptation to treatment, and reduce pain, anxiety and stress levels. Animal-assisted practices are included in the classification of nursing interventions (NIC) and there are sources in the literature that they are used directly as nursing interventions.
The use of models in nursing allows the focus to be on the essence and applications of nursing. One of the important theories used in the field of nursing is the Human Caring Theory (HCT) because it reflects the nursing discipline very well. HCT is a theory that reflects the essence of nursing and includes the concepts of love, compassion, self-compassion, respect, trust, human dignity, morality and ethics and can be applied by integrating with various interventions. The theory values the care given to the individual as well as the existence of the caregiving nurse and has been used in different samples in nursing practice and research for many years.
As psychiatric nurses, protecting and developing the mental health of children with speech and language disorders, who are among the vulnerable groups, is among our primary goals. In studies conducted with children with speech and language disorders, it has been stated that animal-assisted practices increase social interaction, have a better positive mood, reduce anxiety, have positive changes in the number of smiles, observation skills, and blood flow rate, increase self-confidence and creativity, develop communication skills, improve collective work skills, enrich vocabulary, and produce more complex sentences in the speech structure. It is anticipated that animal-assisted practices will reduce the perceived stress level of children with poor communication skills, weak/underdeveloped socialization, and may exhibit avoidance behavior from social events, and will increase social adaptation and communication skills.
In this context, this study was planned to determine the effects of the Animal-Assisted Activity Program Based on Human Caring Theory on the perceived stress, social adaptation and communication skills of children with speech and language disorders.
It is a randomized controlled study and a pretest, posttest control group research design will be used. Research data will be obtained through the Individual Identification Form (IDF), Perceived Stress Scale for Children Aged 7-11, Social Adaptation and Skills Scale for Turkish Children Aged 6-12 Mother Form (SUBÖ-A), Communication Skills Scale and Turkish School Age Language Development Test (TODİL). In addition, vital signs (pulse, blood pressure, respiration) and salivary serotonin level (Elisa Test) will be checked to evaluate the stress level of each child before and after each application.
In the study, it was planned to apply animal-assisted practices as an independent variable to the intervention group, two days a week, in 6 sessions of 40-60 minutes each, while no intervention was applied to the control group. Pre-test, post-test and follow-up data will be obtained simultaneously from the intervention group and the control group. Following the post-test applications, follow-up evaluations will be made to the intervention group and the control group at the end of the first month. The control group will be seen a total of three times, and the intervention group a total of eight times.
The universe of the study will consist of 30 children who applied to the Department of Language and Speech Therapy at Istanbul Atlas University for treatment, and the sample will consist of 30 children who meet the inclusion and exclusion criteria.
The analysis of the data obtained as a result of the research is planned to be done using SPSS 24.0 (Statistical Package for Social Science) package program. In the evaluation of the data, descriptive statistics such as frequency distribution, mean, standard deviation will be used to define the sample. In the analysis of continuous distributions of two groups, Student-t test or Mann-Whitney U test will be used according to the test assumptions, in the comparison of groups within themselves, two-pair test or Wilcoxon pair test will be used according to the parametric test assumptions, in the analysis of categorical data according to groups and in the evaluation of pictures, Chi-square test will be used. In the analyzes, 95% significance level (or α=0.05 margin of error) will be used to determine the differences. The answers given to the open-ended questions will be categorized
Study Overview
Status
Intervention / Treatment
Detailed Description
Animal-assisted practice is an intervention method explained with different mechanisms and theories that provides protection and development of health through human-animal interaction. Animal-assisted practices can be applied to children, adults, elderly, healthy or sick individuals of all ages. Children are among the most commonly used groups. Studies conducted with children have indicated that animal-assisted practices facilitate the expression of emotions, improve health perception, increase communication skills, desire to continue school, increase adaptation to treatment, and reduce pain, anxiety and stress levels. Animal-assisted practices are included in the classification of nursing interventions (NIC) and there are sources in the literature that they are used directly as nursing interventions.
The use of models in nursing allows the focus to be on the essence and applications of nursing. One of the important theories used in the field of nursing is the Human Caring Theory (HCT) because it reflects the nursing discipline very well. HCT is a theory that reflects the essence of nursing and includes the concepts of love, compassion, self-compassion, respect, trust, human dignity, morality and ethics and can be applied by integrating with various interventions. The theory values the care given to the individual as well as the existence of the caregiving nurse and has been used in different samples in nursing practice and research for many years.
As psychiatric nurses, protecting and developing the mental health of children with speech and language disorders, who are among the vulnerable groups, is among our primary goals. In studies conducted with children with speech and language disorders, it has been stated that animal-assisted practices increase social interaction, have a better positive mood, reduce anxiety, have positive changes in the number of smiles, observation skills, and blood flow rate, increase self-confidence and creativity, develop communication skills, improve collective work skills, enrich vocabulary, and produce more complex sentences in the speech structure. It is anticipated that animal-assisted practices will reduce the perceived stress level of children with poor communication skills, weak/underdeveloped socialization, and may exhibit avoidance behavior from social events, and will increase social adaptation and communication skills.
In this context, this study was planned to determine the effects of the Animal-Assisted Activity Program Based on Human Caring Theory on the perceived stress, social adaptation and communication skills of children with speech and language disorders.
It is a randomized controlled study and a pretest, posttest control group research design will be used. Research data will be obtained through the Individual Identification Form (IDF), Perceived Stress Scale for Children Aged 7-11, Social Adaptation and Skills Scale for Turkish Children Aged 6-12 Mother Form (SUBÖ-A), Communication Skills Scale and Turkish School Age Language Development Test (TODİL). In addition, vital signs (pulse, blood pressure, respiration) and salivary serotonin level (Elisa Test) will be checked to evaluate the stress level of each child before and after each application.
In the study, it was planned to apply animal-assisted practices as an independent variable to the intervention group, two days a week, in 6 sessions of 40-60 minutes each, while no intervention was applied to the control group. Pre-test, post-test and follow-up data will be obtained simultaneously from the intervention group and the control group. Following the post-test applications, follow-up evaluations will be made to the intervention group and the control group at the end of the first month. The control group will be seen a total of three times, and the intervention group a total of eight times.
The universe of the study will consist of 30 children who applied to the Department of Language and Speech Therapy at Istanbul Atlas University for treatment, and the sample will consist of 30 children who meet the inclusion and exclusion criteria.
The analysis of the data obtained as a result of the research is planned to be done using SPSS 24.0 (Statistical Package for Social Science) package program. In the evaluation of the data, descriptive statistics such as frequency distribution, mean, standard deviation will be used to define the sample. In the analysis of continuous distributions of two groups, Student-t test or Mann-Whitney U test will be used according to the test assumptions, in the comparison of groups within themselves, two-pair test or Wilcoxon pair test will be used according to the parametric test assumptions, in the analysis of categorical data according to groups and in the evaluation of pictures, Chi-square test will be used. In the analyzes, 95% significance level (or α=0.05 margin of error) will be used to determine the differences. The answers given to the open-ended questions will be categorized by the researchers and evaluated as numbers and percentages.
It is thought that the research will contribute to the scientific literature on this subject, create a data source for the disciplines working with children with speech and language disorders, and provide scientific information that will guide nursing practices, especially within the scope of child-adolescent psychiatric nursing practices. As a result of the research, it will be evaluated whether the animal-assisted activity program is effective on this group. It is predicted that there will be a decrease in the stress level of children with speech and language disorders and an increase in their language, social adaptation and communication skills.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Atlas University
-
-
Kağıthane
-
Istanbul, Kağıthane, Turkey (Türkiye), 34400
- Istanbul Atlas University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Being 7-11 years old,
- Speaking Turkish
- Having one of the following diagnoses: Fluency disorders (stuttering), speech sound disorders, delayed language and speech sound disorders, specific learning disability (dyslexia),
- Parents must give consent for the child to participate in the study
Exclusion criteria:
- Having a language and speech disorder with physiological or neurological causes (Voice, Swallowing, Speech Sound and Neurogenic Speech Disorders)
- Having mental, Down syndrome and autism disorders,
- Having an immune deficiency disease,
- Having a cat allergy/fear,
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 |
|---|---|
|
No Intervention: comparison group
|
|
|
Experimental: Pet therapy group
In the study, it was planned to apply animal-assisted practices as the independent variable to the intervention group in 6 sessions of 40-45 minutes, two days a week, and no intervention was planned for the control group.
|
Animal assisted practice program based on Human Caring Theory
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress
Time Frame: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
Perceived Stress Scale: The Perceived Stress Scale for Children Aged 7-11 was developed by Davis and Turner-Cobb (2022), and its Turkish adaptation was done by Ekşi and Kızık (2023).
The scale was developed to determine the perceived stress level in children aged 7-11 and consists of 10 items.
The scale comprises two sub-dimensions: Perceived Helplessness (items 2, 4, 6, 8, 9) and Perceived Self-Efficacy (items 1, 3, 5, 7, 10).
It is scored on a 5-point Likert scale (1=Never, 5=Always).
Items 1, 3, 5, 7, and 10 are reverse-scored.
Evaluation is based on the total score obtained from the scale, with a higher score indicating a higher stress level.
The minimum score on the scale is 10, and the maximum is 50.
|
Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
|
Social Adaptation and Skills
Time Frame: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
Social adaptation and skills scale-Mother form: The Social Adjustment and Skills Scale for Turkish Children Aged 6-12 Years (SUBÖ-A) Mother Form was developed by Sezgin and Akman (2014).
The scale was designed to assess children's social adjustment and skills levels based on information obtained from mothers.
SUBÖ-A consists of 59 items and is scored using a five-point Likert scale (1=Always like this, 2=Most of the time like this, 3=Sometimes like this, 4=Rarely like this, 5=Never like this).
The scale comprises seven sub-dimensions: Impulsivity, Frustration Threshold, Attention and Hyperactivity, Social Relationships, Mood, Need for Approval, and Introversion.
A minimum score of 59 and a maximum score of 295 can be obtained from the scale.
|
Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
|
Communication Skills
Time Frame: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
Communication Skills Scale: The first version of the Communication Skills Scale was developed by Ersanlı and Balcı and consists of three sub-dimensions (mental, emotional, and behavioral) and 45 items.
Karatekin, Sönmez, and Kuş (2012) adapted the scale to 34 items for primary school students by removing some items.
In the adaptation study, the Cronbach's alpha reliability coefficient of the scale was calculated as .88.
The scale allows for a minimum score of 34 and a maximum score of 170.
|
Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
|
Pulse
Time Frame: Pre-session test for the intervention group (measurements were taken before each session of the 6-week intervention) Post-session test for the intervention group (measurements were taken after each session of the 6-week intervention)
|
vital signs (pulse): In this study, respiratory rate, pulse, and oxygen saturation were measured using digital measuring instruments. Tea and coffee should not have been consumed in the last half hour before the measurement, as these can affect vital signs. Therefore, the measurement was taken by the researcher at least 5 minutes after the child had rested, while the child was sitting quietly, freely, and with both feet on the ground. Pulse: The pressure exerted by the heartbeats on the artery wall, felt with the fingertips. In children, it is between 65-110 beats per minute. Oxygen saturation In our study, pulse levels of the children in the intervention group were measured before and after each intervention, and these values were compared before and after the intervention. |
Pre-session test for the intervention group (measurements were taken before each session of the 6-week intervention) Post-session test for the intervention group (measurements were taken after each session of the 6-week intervention)
|
|
SPO2 Oxygen saturation
Time Frame: Pre-session test for the intervention group (measurements were taken before each session of the 6-week intervention) Post-session test for the intervention group (measurements were taken after each session of the 6-week intervention)
|
SPO2 Oxygen saturation: In this study, respiratory rate, pulse, and oxygen saturation were measured using digital measuring instruments. Prior to the measurement, the child should not have consumed tea or coffee, as these can affect vital signs. Therefore, the measurement was taken at least 5 minutes after the child had rested, while the child was sitting quietly, freely, and with both feet on the ground. Oxygen saturation (SpO2): While oxygen levels vary depending on age group and the individual's condition, values above 96 are considered healthy. The healthy range is 96-100. In our study, oxygen saturation (SpO2) levels were measured in the children in the intervention group before and after each intervention, and these values were compared before and after the intervention. |
Pre-session test for the intervention group (measurements were taken before each session of the 6-week intervention) Post-session test for the intervention group (measurements were taken after each session of the 6-week intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: İlkay Keser, Assoc.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
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Communication Disorders
- Language Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Personal Satisfaction
- Communication
- Speech Disorders
- Psychological Well-Being
- Language
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Animal Assisted Therapy
- Nursing Care
Other Study ID Numbers
- 01313
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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 Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet Therap
-
Winterlight LabsActive, not recruitingPsychiatric Disorder | Language | SpeechCanada
-
Fundació Sant Joan de DéuInstituto de Investigación Marqués de Valdecilla; Col·legi Oficial Infermeres...CompletedMental Health Disorder | Case Management | Psychiatric NursingSpain
-
University of IoanninaDOTSOFT SA - GR; TELEGLOBAL LP - GR; Region of Epirus (Regional Operational Programme... and other collaboratorsCompletedDevelopmental Articulation Disorder | Developmental Language Disorders | Speech Disorder | Neurodevelopmental Disorder (Diagnosis)Greece
-
Altec Inc.CompletedSpeech Disorders | Speech Perception | Rehabilitation of Speech and Language Disorders | Speech, Alaryngeal | Communication Aids for Disabled | Speech IntelligibilityUnited States
-
University of Central FloridaNational Institute on Deafness and Other Communication Disorders (NIDCD); University...CompletedDown Syndrome | Speech Sound Disorder | Speech Disorders in Children | Speech Intelligibility | Speech and Language DisorderUnited States
-
Centre Hospitalier Charles Perrens, BordeauxRecruitingMental Health | Psychiatric Disorder | Aging DisorderFrance
-
Tali BertlerActive, not recruitingPsychiatric Disorder | Mental Health IssueIsrael
-
Fondation Santé des Étudiants de FranceRecruitingPsychiatric Disorder | Adolescent Behavior | Mental Health IssueFrance
-
Michael RuferUniversity of ZurichEnrolling by invitationHealth Care Utilization | Chronic Psychiatric Disorder | Psychiatric Hospitalization | Intensive Care Psychiatric Disorder | Rehospitalization | High Utilization / Heavy UseSwitzerland
-
Centre Hospitalier Universitaire, AmiensCompletedLanguage Development Disorders | Therapy | Speech and Language DisorderFrance
Clinical Trials on Nursing Care
-
IRCCS Centro Neurolesi Bonino PulejoCompleted
-
Mehtap GümüşayCompletedQuality of Life | Nursing Caries | Surgical MenopauseTurkey
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Completed
-
Chung Shan Medical UniversityCompletedCancer Patients | Radiation Therapy | TattooingTaiwan
-
French Society for Intensive CareCompletedCritical Care | Nursing CariesFrance, Switzerland, Belgium, Luxembourg
-
Ataturk UniversityNot yet recruitingKnee ArthroplastyTurkey (Türkiye)
-
Second Affiliated Hospital, School of Medicine,...Unknown
-
Hacettepe UniversityCompletedImplantable Cardioverter-defibrillators (ICDs)Turkey (Türkiye)
-
Reva Balci AkpinarAtaturk UniversityNot yet recruitingHemodialysis Complication | Nurse's RoleTurkey
-
Tokat Gaziosmanpasa UniversityAnkara City Hospital BilkentEnrolling by invitationNursing Caries | Self Confidence | Newborn | AttachmentTurkey