Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet TherapNCT07512180
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
A study testing Nursing Care in people with Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet Therap, run by Şeyma Demiralay at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet Therap
- What is being tested?
- Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 23 Sep 2025
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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,
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Atlas University
Istanbul, Kağıthane, 34400
İstanbul Atlas University
Istanbul
About this study
Official title: 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.
Read more
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
Read the 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.
- Being tested
- Nursing Care
- Keywords
- language and speech disorder, psychiatric nursing, mental health, pet therapy, model, nursing model
- Medical subject headings
- Language, Speech Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing CareBehavioural
Also called pet therapy
Animal assisted practice program based on Human Caring Theory
| Study group | Role | What they receive |
|---|---|---|
| Pet therapy group | Experimental | 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. Receives: Behavioral: Nursing Care |
| comparison group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
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.
Measured: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
Social Adaptation and Skills
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.
Measured: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
Communication Skills
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.
Measured: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)
Pulse
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start20 Jun 2025
- Primary completion23 Aug 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet TherapStudies 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
- animal assisted practice program based on human caring theory
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şeyma Demiralay
- Sponsor type
- University, hospital or other
- Collaborators
- Atlas University
- Responsible party
- Sponsor-investigator, Şeyma Demiralay, Akdeniz University
- Investigators
- İlkay Keser, Assoc.Prof., Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512180
- Sponsor's protocol ID
- 01313
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share if necessary
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal-Assisted Activity Programme Based on Human Caring Theory With Speech and Language Disorders
- ClinicalTrials.gov ID
- NCT07512180
- Acronym / sponsor ID
- 01313
- Keywords
- language and speech disorder, psychiatric nursing, mental health, pet therapy, model, nursing model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Şeyma DemiralayUniversity, hospital or other
- Collaborators
- Atlas University
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 23 Aug 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 6 Apr 2026 (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.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- animal assisted practice program based on human caring theory
| Arm | Type | Receives |
|---|---|---|
| Pet therapy group | Experimental | Behavioral: Nursing CareIn 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. |
| comparison group | No intervention | – |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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,
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 |
|---|---|---|
| Nursing CareAlso: pet therapyAnimal assisted practice program based on Human Caring Theory | Behavioural | Pet therapy group |
Primary outcome
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.
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.
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.
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.
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.
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 6 Apr 2026.
- Individual participant dataSharing planned: Yes. We can share if necessary
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, Assoc.Prof. study director
Akdeniz University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Care in people with Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet Therap, run by Şeyma Demiralay at 2 sites 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 4 inclusion and 4 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)). The study lists 5 primary outcomes in all. 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 6 Apr 2026.