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临床试验/NCT06280612
NCT06280612已完成不适用

The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients' Post-Chemotherapy Symptoms and Happiness Levels: A Randomized Controlled Study

Karadeniz Technical University2 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Edmonton Symptom Diagnostic Scale

研究概览

简要总结

It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Since the possibility of patients being affected by each other was minimal, the study was continued with only one of the live cat groups, the simulation cat group, and the control group. For example, only the live cat group and those who received chemotherapy treatment were studied before Monday afternoon.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Robotic Cat Group

Experimental

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.

干预措施: Pet therapy (Other)

Live Cat Group

Experimental

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.

干预措施: Pet therapy (Other)

Control Group

No Intervention

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.

结局指标

主要结局

Edmonton Symptom Diagnostic Scale

时间窗: 12 Weeks

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).

Oxford Happiness Scale Short Form

时间窗: 12 Weeks

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Demirağ, Ph.D

Asst. Prof.

Karadeniz Technical University

研究点 (2)

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