Effects of Robotic Cat and Betta Fish Therapies in Hemodialysis Patients

NCT ID: NCT05339711

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-09-01

Brief Summary

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The research was carried out as a randomized controlled trial to examine the physiological and psychological effects of robotic cat and Betta fish therapies in hemodialysis patients.

Detailed Description

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Along with the benefit of hemodialysis treatment, patients develop physical and psychosocial problems and symptoms associated with hemodialysis. Undesirable symptoms experienced by patients undergoing hemodialysis include hypotension/hypertension, respiratory distress, headache, back-chest pain, muscle cramps, nausea-vomiting, fatigue, fever, constipation, diarrhea, itching. In addition to negative feelings such as anger, anxiety, unhappiness and fear associated with hemodialysis, patients often experience adjustment disorder, anxiety, depression and sleep disorders, and may experience social isolation and loneliness with the fear of being a burden to their friends or family members. The physical symptoms that patients receiving hemodialysis treatment have to cope with and psychological symptoms such as unhappiness and loneliness make it difficult to adapt to their disease and contribute to an increase in mortality.

Today, "pet therapy" is used for treatment in many hospitals, psychiatry clinics, nursing homes and rehabilitation centers. Pet therapy is an application in the Nursing Interventions Classification. In studies with different animals on different populations in health services, hospitals, psychiatry clinics, nursing homes and rehabilitation centers, pet therapy; It is stated that it has physiological and psychological benefits such as decrease in psychiatric signs and symptoms, increase in cardiovascular system functionality, increase in socialization skills and individual self-management. It is reported that the physiological and psychological benefits of pet therapy applications have been proven in many of the studies using many animals (such as birds, dogs, cats, fish) and robot simulations. It has been reported that robotic pet therapy reduces depression, agitated behaviors, pain, stress hormone levels and loneliness, increases heart rate, happiness, and quality of life. Again, it is stated that even a simple movement of live animals reduces loneliness, anxiety, depression and social isolation in humans.

It has been determined that an unpublished experimental doctoral thesis study, of which a poster statement can be reached, was conducted abroad on the effect of "the effect of pet therapy with live dogs on depression" in patients with CRF. Again, one pilot study and one pre-test-post-test study were found in which the effect of pet therapy on happiness with a live dog was examined. In Turkey, no study was found with pet therapy in patients undergoing CRF and hemodialysis. However, there is limited information in the literature about the benefits of human-fish interactions related to pet therapy. It has been reported that ornamental betta fish increase individual self-management, and reduce anxiety and stress. In a systematic review, it was reported that various fish species reduced anxiety, physiological stress, anxiety and pain, provided relaxation, improved food intake, had positive benefits on mood and body weight (weight gain), but no information was found about loneliness.

About the subject, only pet therapy with live dogs was used in hemodialysis patients, and no experimental study was found. In addition, it was determined that there was no information about the effect of Betta fish therapy on loneliness and that happiness, dialysis symptoms, compliance with ESRD, and body mass index (BMI) were not examined before in patients undergoing hemodialysis. The fact that the mentioned parameters were not examined indicates that there is a lack of evaluation of robotic cat or Betta fish therapies. In line with this information, the aim of this study was to examine the positive physiological (dialysis symptoms, BMI) and psychological (dialysis symptoms, happiness, loneliness, adaptation to ESRD) effects of robotic cat and Betta fish therapies in patients undergoing hemodialysis.

Conditions

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Hemodialysis Animal Assisted Therapy Adaptation Happiness Loneliness Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Power analysis was performed in the selection of patients to be sampled. The number of samples, the G\*Power program 3.1.9.6 error rate α=0.05, and due to the lack of work he has done on the subject before in different populations (old) (32) pet therapy is a targeted domain 0.475 three groups (robot kedi grubu, Betta balık grubu, kontrol grubu) by reference to the size and power of test work is 0.80 (80%), while for a group of three in total, 48 (16 for each group) patients was calculated. Considering situations such as wanting to leave the study or death during the study, each group was increased by 10% and a total of 54 patients were included in the study, 18 patients for each group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

While the patients were randomized; In order to keep the possibility of being affected by each other at a minimum level, the study was continued with the same application group in the same session group. For example; It's like working only with the robot cat group in the 08:00-12:00 session group on Mondays. In order to reduce the possibility of selection bias due to sample selection, "single-stage cluster type random sampling", which is a subtype of random sampling, was used. In addition, before the study, patients were informed about the study and their consent was obtained.

Study Groups

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Robotic Pet Therapy/Robot Cat Group

In the robot cat group, the patients were given face-to-face personal information about the robot cat for about 15 minutes in the waiting room by the researcher, and the "Robot Cat Information Brochure" was given. Therefore, in this study, the patients interacted with the robot cat "Silver" for 20 minutes during the hemodialysis session once a week for eight weeks (two months) under the supervision of the researcher. After eight weeks of robotic pet therapy in the hemodialysis unit, this group of patients was followed up by the researcher with the same applications, without robotic pet therapy for eight more weeks. Data collection tools were applied to this group of patients before the study. Again, in the last week of the 1st, 2nd, 3rd and 4th months of the study, all other data collection tools were applied, except the "Structured Patient Information Form".

Group Type EXPERIMENTAL

Robotic Pet Therapy/Robot Cat Group

Intervention Type OTHER

İn this study, the patients interacted with the robot cat "Silver" for 20 minutes during the hemodialysis session once a week for eight weeks (two months) under the supervision of the researcher.

Pet Therapy/Betta Fish Group

In the Betta fish group, the patients were given a 15-minute hands-on, face-to-face, individual information about Betta fish care in the waiting room by the researcher, and a "Betta Fish Information Brochure" was given to the patients. Then, the patients were asked to take care of the fish given to them at home for two months.This group of patients was given pet therapy for eight weeks, and then followed by the researcher with the same practices for another eight weeks without pet therapy. In order to observe or measure the positive effects of fish on patients, patients should spend at least 10 minutes with fish during the day (52). Data collection tools were applied to this group of patients before the study. Again, in the last week of the 1st, 2nd, 3rd and 4th months of the study, all other data collection tools were applied, except the "Structured Patient Information Form".

Group Type EXPERIMENTAL

Pet Therapy/Betta Fish Group

Intervention Type OTHER

İn this study, two fish and the necessary materials (aquarium, fish food, plastic plant, aquarium stone, etc.) were given to the patients by the researcher to keep pets for eight weeks.

Control Group

This group of patients was only informed about the study and received routine hemodialysis treatment. The patients were followed for four months. Data collection tools were applied to the patients before the study. Again, in the last week of the 1st, 2nd, 3rd and 4th months of the study, all other data collection tools were applied, except the "Structured Patient Information Form".

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Robotic Pet Therapy/Robot Cat Group

İn this study, the patients interacted with the robot cat "Silver" for 20 minutes during the hemodialysis session once a week for eight weeks (two months) under the supervision of the researcher.

Intervention Type OTHER

Pet Therapy/Betta Fish Group

İn this study, two fish and the necessary materials (aquarium, fish food, plastic plant, aquarium stone, etc.) were given to the patients by the researcher to keep pets for eight weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Being ≥18 years old,
* Accepting to participate in the research,
* Being literate,
* Being able to communicate verbally,
* Receiving outpatient hemodialysis treatment three times a week in the same institution,
* Absence of any impairment in mental and cognitive functions,
* Weight and height measurements can be made while standing,
* Being on hemodialysis treatment for at least three months (33),
* Being able to perform self-care activities independently,
* Not having allergies for patients in the robot cat group,
* Desiring to spend time with the robotic cat "Silver" during hemodialysis by the patients in the robot cat group,
* Wanting to nutrition and care fish at home by patients in the betta fish group.

Exclusion Criteria

* Refusal to participate in the research,
* Being on peritoneal dialysis,
* Being diagnosed with a psychiatric disorder diagnosed by a psychiatrist,
* Unstable general condition (hemodynamically) (heart rate \<60 beats/min, systolic blood pressure \<100 mm/Hg or diastolic blood pressure \<60 mm/Hg),
* Patients with chronic obstructive pulmonary disease (COPD) (except Mild COPD Stage 1) and advanced heart failure were identified (34, 35).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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Hatice Demirağ, Ph.D

Lecturer, Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karadeniz Tecnical University

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Demirag H, Hintistan S. Investigation of physiological and psychological effects of robotic cat and betta fish therapies in hemodialysis patients: A randomized controlled study. Complement Ther Clin Pract. 2022 Nov;49:101647. doi: 10.1016/j.ctcp.2022.101647. Epub 2022 Jul 31.

Reference Type DERIVED
PMID: 35932699 (View on PubMed)

Other Identifiers

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RCS09042022

Identifier Type: -

Identifier Source: org_study_id

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