Old Age; DebilityNCT05724927
The Effect of Animal Assisted Activity to Elderly
A study testing Animal assisted activity in people with Old Age; Debility and Nursing Home, run by Atlas University.
Trial summary
There is a global increase in the elderly population day by day. Biopsychosocial regressions and various health problems are seen in the elderly, and their care and follow-up are mostly carried out in nursing homes. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility, Nursing Home, Loss of Interest in Activities
- What is being tested?
- Animal assisted activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 17 Nov 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 60 years or older
- Do not speak Turkish
- Continuing hospitalization in the specified institution,
- Volunteering to participate in the study
Who cannot join
- Having a barrier to communication,
- Having a diagnosis of any mental disorder,
- Having a physical, auditory, visual and cognitive disability that will prevent the goldfish in the aquarium from feeding (feeding) twice daily, within the scope of the study,
- Being allergic to fish and fish food,
- Fear of goldfish to be used in the study
About this study
Official title: The Effect of Animal Assisted Activity Applied to Elderly Individuals Living in Nursing Homes on Depression and Loneliness Levels of Individuals: I Share My Loneliness Project"
There is a global increase in the elderly population day by day. Biopsychosocial regressions and various health problems are seen in the elderly, and their care and follow-up are mostly carried out in nursing homes. It is stated that the elderly individuals living in the nursing home see the institution related to the institution they stay as an area for making friends and socializing with their peers, but the elderly individuals staying in these institutions experience various limitations. If the elderly individual's assessment of his life is positive, self-compassion is achieved, if it is negative, he falls into despair, depressive mood and loneliness symptoms can be seen. Various psychosocial interventions are recommended for elderly individuals within the scope of protecting and improving mental health. One of the interventions that can be done is animal-supported activities that provide human-animal interaction. Studies conducted in our country with animal-supported activities are very limited, and they have mostly been studied with children. In the international literature, although there are various studies within the scope of animal-supported activities, the number of studies evaluating the effect of interaction with fish is very limited, and studies with fish interaction have been recommended by various researchers. This study is unique because it is the first study in our country to evaluate the effects of animal-assisted practices on the psychosocial health of elderly individuals living in nursing homes.
Read the detailed description
At the end of the study, it is predicted that the depression and loneliness levels of elderly individuals will decrease. Undergraduate students taking part in the study will also experience doing an experimental study. When considered in the context of Erikson's psychosocial development theory, it is thought that it is important to support the elderly individuals psychosocially in old age, which is the last stage of life. The study is an experimental study designed in a pretest and posttest pattern. The universe of the study; All nursing homes (n=12) in Şişli district will consist of elderly individuals receiving health care services. In the selection of the sample, first of all, the institution where the study will be carried out will be determined by drawing lots among the institutions, and the elderly individuals who meet the inclusion and exclusion criteria will form the sample of the study. Data will be obtained with Personal Information Form (KBF), Loneliness Scale for the Elderly (YİYÖ), Yesavage Geriatric Depression Scale-Short Form (GDS-SF) scales. Interviews will be held individually, twice a week, for a total of 6 times, including introduction (1), study (4) and termination (1). In the study, answers to the question "Is there a difference between the depression and loneliness levels of individuals before and after animal-supported activities?" will be sought. The analysis of the data will be done using the Statictical Package for Social Science 23.0 package program. In the evaluation of the data, descriptive statistics such as frequency distribution, mean and standard deviation will be used to define the sample, two-pair test or Wilcoxon peer test will be used according to the parametric test assumptions for the comparison of the group within itself, and the Chi-square test will be used for the analysis of categorical data. 95% significance level will be used to determine the differences in the analyses. The answers to the open-ended questions will be categorized by the researchers and evaluated as numbers and percentages. As a result of the study, the effect of animal-supported activities on the depression and loneliness levels of the elderly will be determined and a contribution will be made to the literature. In line with the literature and justification, this study was planned to determine the effects of animal-supported activities on depression and loneliness levels in elderly individuals living in nursing homes.
- Being tested
- Animal assisted activity
- Keywords
- Elderly, Animal assisted activity, Loneliness, Depression, Nursing intervention
- Medical subject headings
- Frailty, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal assisted activityBehavioural
Also called animal assisted therapy, pet therapy, animal assisted intervention
The interviews consist of a total of six interviews, including an introduction, four studies, and a termination. Interviews will be held individually in each person's own room in the nursing home. Materials such as plastic aquarium, fish, fish food, fish food scales that will be given to the individuals during the interviews will be taken to the institution by the researchers before and will be given to the elderly individuals in the second interview.
| Study group | Role | What they receive |
|---|---|---|
| Animal Assisted İntervention | Experimental | A total of four study interviews will be held within the scope of animal-supported activities, two days a week, from the elderly individuals in the nursing home to the participants included in the study. Receives: Behavioral: Animal assisted activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression scale
It was planned to be measured with the Yesavage Geriatric Depression Scale-Short Form (GDS-SF). The answers are "yes" or "no" depending on the sentiment at the end. A "yes" answer is given 1 point, and a "no" answer is given 0 points. A minimum of 0 and a maximum of 15 points can be obtained from the scale. 0-4 points are considered as "no depression", 5-8 points as "mild depression", 9-11 points as "moderate depression" and 12-15 points as "severe depression".
Measured: "Before any intervention is made (Pre-test) (T0)" AND "Animal Assisted Activity Program- Short Form application right after it's over (Posttest) (T1)"
Loneliness
It was planned to be measured with the Loneliness Scale for the Elderly. The lowest score to be taken from the scale is 0 and the highest score is 22. Total loneliness can be divided into four levels: Level 1; not alone / does not feel lonely (score 0-4); Level 2; acceptable loneliness (5-14 points); Level 3; very lonely (score15-18); Level 4; Very intense loneliness (score 19-22)
Measured: "Before any intervention is made (Pre-test) (T0)" AND "Animal Assisted Activity Program- Short Form application right after it's over (Posttest) (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start20 Feb 2023 (estimated)
- Primary completion17 Nov 2023 (estimated)
- Study completion17 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- quasi-experimental in a single group pretest-posttest research design
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724927
- Sponsor's protocol ID
- AtlasU
- Other IDs
- 1919B012203442
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share to contribute to the literature
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animal Assisted Activity Applied to Elderly Individuals Living in Nursing Homes on Depression and Loneliness Levels of Individuals: I Share My Loneliness Project"
- ClinicalTrials.gov ID
- NCT05724927
- Acronym / sponsor ID
- AtlasU
- Keywords
- Elderly, Animal assisted activity, Loneliness, Depression, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 17 Nov 2023 (estimated)
- Study completion
- 17 Nov 2023 (estimated)
- First posted
- 13 Feb 2023 (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.
There is a global increase in the elderly population day by day. Biopsychosocial regressions and various health problems are seen in the elderly, and their care and follow-up are mostly carried out in nursing homes. It is stated that the elderly individuals living in the nursing home see the institution related to the institution they stay as an area for making friends and socializing with their peers, but the elderly individuals staying in these institutions experience various limitations. If the elderly individual's assessment of his life is positive, self-compassion is achieved, if it is negative, he falls into despair, depressive mood and loneliness symptoms can be seen. Various psychosocial interventions are recommended for elderly individuals within the scope of protecting and improving mental health. One of the interventions that can be done is animal-supported activities that provide human-animal interaction. Studies conducted in our country with animal-supported activities are very limited, and they have mostly been studied with children. In the international literature, although there are various studies within the scope of animal-supported activities, the number of studies evaluating the effect of interaction with fish is very limited, and studies with fish interaction have been recommended by various researchers. This study is unique because it is the first study in our country to evaluate the effects of animal-assisted practices on the psychosocial health of elderly individuals living in nursing homes.
Detailed description
At the end of the study, it is predicted that the depression and loneliness levels of elderly individuals will decrease. Undergraduate students taking part in the study will also experience doing an experimental study. When considered in the context of Erikson's psychosocial development theory, it is thought that it is important to support the elderly individuals psychosocially in old age, which is the last stage of life. The study is an experimental study designed in a pretest and posttest pattern. The universe of the study; All nursing homes (n=12) in Şişli district will consist of elderly individuals receiving health care services. In the selection of the sample, first of all, the institution where the study will be carried out will be determined by drawing lots among the institutions, and the elderly individuals who meet the inclusion and exclusion criteria will form the sample of the study. Data will be obtained with Personal Information Form (KBF), Loneliness Scale for the Elderly (YİYÖ), Yesavage Geriatric Depression Scale-Short Form (GDS-SF) scales. Interviews will be held individually, twice a week, for a total of 6 times, including introduction (1), study (4) and termination (1). In the study, answers to the question "Is there a difference between the depression and loneliness levels of individuals before and after animal-supported activities?" will be sought. The analysis of the data will be done using the Statictical Package for Social Science 23.0 package program. In the evaluation of the data, descriptive statistics such as frequency distribution, mean and standard deviation will be used to define the sample, two-pair test or Wilcoxon peer test will be used according to the parametric test assumptions for the comparison of the group within itself, and the Chi-square test will be used for the analysis of categorical data. 95% significance level will be used to determine the differences in the analyses. The answers to the open-ended questions will be categorized by the researchers and evaluated as numbers and percentages. As a result of the study, the effect of animal-supported activities on the depression and loneliness levels of the elderly will be determined and a contribution will be made to the literature. In line with the literature and justification, this study was planned to determine the effects of animal-supported activities on depression and loneliness levels in elderly individuals living in nursing homes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi-experimental in a single group pretest-posttest research design
| Arm | Type | Receives |
|---|---|---|
| Animal Assisted İntervention | Experimental | Behavioral: Animal assisted activityA total of four study interviews will be held within the scope of animal-supported activities, two days a week, from the elderly individuals in the nursing home to the participants included in the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 60 years or older
- Do not speak Turkish
- Continuing hospitalization in the specified institution,
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- Having a barrier to communication,
- Having a diagnosis of any mental disorder,
- Having a physical, auditory, visual and cognitive disability that will prevent the goldfish in the aquarium from feeding (feeding) twice daily, within the scope of the study,
- Being allergic to fish and fish food,
- Fear of goldfish to be used in the study
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 activityAlso: animal assisted therapy, pet therapy, animal assisted interventionThe interviews consist of a total of six interviews, including an introduction, four studies, and a termination. Interviews will be held individually in each person's own room in the nursing home. Materials such as plastic aquarium, fish, fish food, fish food scales that will be given to the individuals during the interviews will be taken to the institution by the researchers before and will be given to the elderly individuals in the second interview. | Behavioural | Animal Assisted İntervention |
Primary outcome
Depression scale
Time frame: "Before any intervention is made (Pre-test) (T0)" AND "Animal Assisted Activity Program- Short Form application right after it's over (Posttest) (T1)"
It was planned to be measured with the Yesavage Geriatric Depression Scale-Short Form (GDS-SF). The answers are "yes" or "no" depending on the sentiment at the end. A "yes" answer is given 1 point, and a "no" answer is given 0 points. A minimum of 0 and a maximum of 15 points can be obtained from the scale. 0-4 points are considered as "no depression", 5-8 points as "mild depression", 9-11 points as "moderate depression" and 12-15 points as "severe depression".
Loneliness
Time frame: "Before any intervention is made (Pre-test) (T0)" AND "Animal Assisted Activity Program- Short Form application right after it's over (Posttest) (T1)
It was planned to be measured with the Loneliness Scale for the Elderly. The lowest score to be taken from the scale is 0 and the highest score is 22. Total loneliness can be divided into four levels: Level 1; not alone / does not feel lonely (score 0-4); Level 2; acceptable loneliness (5-14 points); Level 3; very lonely (score15-18); Level 4; Very intense loneliness (score 19-22)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Yes. We can share to contribute to the literature
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Animal assisted activity in people with Old Age; Debility and Nursing Home, run by Atlas University.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Depression scale (time frame: "Before any intervention is made (Pre-test) (T0)" AND "Animal Assisted Activity Program- Short Form application right after it's over (Posttest) (T1)"). The study lists 2 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 13 Feb 2023.