NCT06280612

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 20, 2024

Last Update Submit

February 28, 2024

Conditions

Keywords

pet therapycancer patienthappinesssymptoms

Outcome Measures

Primary Outcomes (2)

  • Edmonton Symptom Diagnostic Scale

    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

  • Oxford Happiness Scale Short Form

    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

Study Arms (3)

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.

Other: Pet therapy

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.

Other: Pet therapy

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.

Interventions

The patients were allowed to spend time with an animal (cat/robotic cat) for 20 minutes twice a week for 12 weeks.

Live Cat GroupRobotic Cat Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gümüşhane University

Gümüşhane, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms, Second Primary

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample number of the research was calculated in the G\*Power 3.1.9.6 program. While α=0.05 was the error amount, 0.628 was the effect size, and 0.90 (90%) was the targeted test power, it was calculated as 36 patients for three groups (living cat group, robotic cat group, control group). Since there was no previous study on the subject, a study examining happiness levels in a different sample group was used as a reference. Considering situations such as wanting to leave the study or death during the research, each group was increased by 25%, and a total of 45 patients, 15 patients for each group, were included in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

June 1, 2023

Primary Completion

July 15, 2023

Study Completion

September 1, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

I'll decide later

Locations