- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06280612
The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients
The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients' Post-Chemotherapy Symptoms and Happiness Levels: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cancer is a disease that requires a long-term struggle with the psychosocial and economic burden it creates on the individual, family and society, bringing with it many health problems. Although chemotherapy treatment is the main treatment method for patients, it can cause some changes in the individual's appearance while treating cancer and many symptoms such as nausea, vomiting, diarrhea, alopecia, and constipation after treatment. At the same time, patients may feel tired, sleepy and depressed after treatment. However, cancer patients and their families experiencing some unknown diagnosis and treatment processes related to cancer also cause them to be unhappy as a result of experiencing some physical, social, emotional and spiritual problems during the treatment.
It is reported in the literature that pet therapy or animal-assisted treatments reduce disease-related symptoms and make patients happy. Pet therapy is an auxiliary non-pharmacological form of treatment that heals physiological and psychological diseases through interactions between animals and humans that meet certain criteria, and stimulates and activates the body mechanisms required for the development of the individual's health behaviors. In the literature, pet therapy studies with oncology patients are quite limited. Therefore, this study was conducted to examine the effects of live cat and robotic cat therapies on the symptoms and happiness levels experienced by oncology patients after chemotherapy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gümüşhane, Turkey, 29600
- Gumushane University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Criteria for admission to the study are 18≤ of age,
- Agreeing to participate in the research,
- Being conscious of receiving outpatient chemotherapy treatment for 3≤ months, and being able to communicate.
- The criteria included no impairment in mental and cognitive functions of patients/relatives in the live group,
- Patients in the live cat group not having any animal allergies, and the cat group having a cat.
Exclusion Criteria:
- Not agreeing to participate in the research,
- Being under 18 years of age,
- Having known psychological disorders, having a visual, hearing, or speech disability, and having an animal allergy.
- Also excluded are having a surgical wound (suture, drainage, etc.), neutropenia or severe infection (by resistant bacteria), fever, diarrhea, respiratory symptoms or vomiting during the week before the start of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Live Cat Group
Before starting the study, the "Structured Patient Information Form," "Edmonton Symptom Diagnosis Scale," and "Oxford Happiness Scale Short Form" were applied to the patients.
Then, the researcher gave the patients face-to-face, individual information about hand hygiene after contact with a live cat for approximately 15 minutes in the waiting room and offered them a "Live Cat Information Brochure."
Patients were then asked to spend 20 minutes with a pet at home twice a week for 12 weeks.
"Edmonton Symptom Diagnosis Scale" and "Oxford Happiness Scale Short Form" were applied to this group of patients three times: before, at the 6th week, and at the end of the 12th week of the study.
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The patients were allowed to spend time with an animal (cat/robotic cat) for 20 minutes twice a week for 12 weeks.
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Experimental: Robotic Cat Group
Before starting the study, the "Structured Patient Information Form," "Edmonton Symptom Diagnosis Scale," and "Oxford Happiness Scale Short Form" were applied to the patients.
Then, the researcher gave the patients face-to-face information about the robotic cat "Silver" and its use for approximately 15 minutes in the waiting room and offered them a "Robotic Cat Information Brochure."
In each pet therapy application, patients' hand hygiene and cleaning of the Robotic Cat was provided, the robot cat was given to the patients.
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The patients were allowed to spend time with an animal (cat/robotic cat) for 20 minutes twice a week for 12 weeks.
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No Intervention: Control Group
Before starting the study, the "Structured Patient Information Form", "Edmonton Symptom Diagnosis Scale", and "Oxford Happiness Scale Short Form" were applied to the patients.
Treatment was given to this group of patients only after informing them about the study, and the patients were followed for only three months.
"Edmonton Symptom Diagnosis Scale" and "Oxford Happiness Scale Short FormS" were applied to the patients three times: before, at the 6th week, and the end of the 12th week of the research.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Edmonton Symptom Diagnostic Scale
Time Frame: 12 Weeks
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The scale includes "pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, the feeling of well-being, shortness of breath and other problems (changes in the skin and nails, sores in the mouth, numbness in the hands)." Sadırlı and Ünsar added other problems to the scale. Therefore, the current version with 11 items was used in this study. The severity of each symptom ranges from "no symptoms" to "very severe," with increasing numerical intensity between 0 and 10. "Edmonton Symptom Diagnostic Scale" were administered to the patients three times in total before the study (pretest), at the sixth week/middle (intermediate measurement), and the end of the 12th week/end of the survey (posttest). |
12 Weeks
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Oxford Happiness Scale Short Form
Time Frame: 12 Weeks
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In the Turkish adaptation, the scale has seven items and a 5-point Likert type. The scores obtained from the items on the scale vary from "1 point: I Completely Disagree" to "5 points: I Completely Agree", with the lowest being seven and the highest being 35 points. "Oxford Happiness Scale Short Form" were administered to the patients three times in total before the study (pretest), at the sixth week/middle (intermediate measurement), and the end of the 12th week/end of the survey (posttest). |
12 Weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCS10042023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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