ClinicalTrials.gg
CompletedNCT07512180Updated Apr 6, 2026

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

An interventional study of Nursing Care in Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet Therap, sponsored by Şeyma Demiralay. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Şeyma Demiralay · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Study 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. 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

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.

02

Conditions studied

  • Language and Speech Disorder, Psychiatric Nursing, Mental Health, Pet Therap

Keywords

  • language and speech disorder
  • psychiatric nursing
  • mental health
  • pet therapy
  • model
  • nursing model
03

In context

Language

243 studies on the registry are indexed under Language; 76 are open to participants now.

This study's enrollment of 36 is below the median of 65 across 158 interventional studies indexed under Language.

Browse Language studies →

Lead sponsor

Şeyma Demiralay is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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,
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • 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.

    Behavioral: Nursing Care

  • No intervention
    comparison group

Interventions

  • BehavioralNursing Care

    Animal assisted practice program based on Human Caring Theory

    Also known as: pet therapy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)

  2. 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.

    Time frame: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)

  3. 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.

    Time frame: Pre-test (6 weeks before intervention) Post-test (6 weeks after intervention) Follow-up (1 month after post-test evaluation)

  4. 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.

    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)

  5. 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.

    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)

07

Study locations

2 sites
  • İstanbul Atlas University
    Istanbul, Kağıthane 34400, Turkey (Türkiye)
  • İstanbul Atlas University
    Istanbul, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — We can share if necessary

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: 6 months

Access criteria: Contacting authors

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Aug 2025, 2 months.

Of 89 non-industry interventional studies with no phase under Language, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's 2 months is below that.

Counting every sponsor, half of 93 studies reached it within 33 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2025
First posted
Apr 6, 2026
StartActual
Jun 20, 2025
Primary completionActual
Aug 23, 2025
CompletionActual
Sep 23, 2025
Last update
Apr 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07512180
Lead sponsor
Şeyma Demiralay
Collaborators
Atlas University
Responsible party
Şeyma Demiralay (Research Assistant, Akdeniz University) — Sponsor-investigator
First posted
Apr 6, 2026
Start date
Jun 20, 2025
Primary completion
Aug 23, 2025
Completion
Sep 23, 2025
Last update
Apr 6, 2026

Study contacts

İlkay Keser, Assoc.Prof.
study director · Akdeniz University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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