The Effect of Animal Assisted Activity to Elderly

February 10, 2023 updated by: Atlas University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being 60 years or older
  • Do not speak Turkish
  • Continuing hospitalization in the specified institution,
  • Volunteering to participate in the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Animal Assisted İntervention
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.
Behavioral: Animal assisted activity
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.
Other Names:
  • animal assisted therapy
  • pet therapy
  • animal assisted intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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".
"Before any intervention is made (Pre-test) (T0)" AND "Animal Assisted Activity Program- Short Form application right after it's over (Posttest) (T1)"
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)
"Before any intervention is made (Pre-test) (T0)" AND "Animal Assisted Activity Program- Short Form application right after it's over (Posttest) (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AtlasU
  • 1919B012203442 (OTHER_GRANT: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We can share to contribute to the literature

IPD Sharing Time Frame

Shareable for 1 year

IPD Sharing Access Criteria

Researchers who want to access the study protocol can access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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