Clinical trial NCT05339711: Effects of Robotic Cat and Betta Fish Therapies in Hemodialysis Patients
Official title: Investigation of Physiological and Psychological Effects of Robotic Cat and Betta Fish Therapies in Hemodialysis Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Animal Assisted Therapy
Adaptation
Happiness
Loneliness
Symptom
Keywords: Adaptation
Happiness
Hemodialysis
Loneliness
Pet therapy
Symptom
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Body mass İndex Monitoring
timeFrame: 16 week
measure: De Jong Gierveld Loneliness Scale
timeFrame: 16 week
measure: Subjective Happiness Scale (SHS)
timeFrame: 16 week
measure: End Stage Renal Disease (ESRD)-Adherence Questionnaire
timeFrame: 16 week
measure: Dialysis Symptom Index (DSİ)
timeFrame: 16 week
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical University
Study officials:
References:
citation: 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.