Effects of Robotic Cat and Betta Fish Therapies in Hemodialysis Patients

NCT05339711 | Completed DMC

• 1 other identifier: RCS09042022
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Animal Assisted Therapy; Adaptation; Happiness; Loneliness; Symptom

Keywords

Adaptation; Happiness; Hemodialysis; Loneliness; Pet therapy; Symptom

Outcome Measures

Primary Outcomes (5)

• Body mass İndex Monitoring

  This form includes BMI, an anthropometric measurement. To obtain the Body Mass Index, the patient's body weight (kg) was divided by the square of the height (m) (BMI=kg/m2). Before the research, 5 measurements were made, twice in the 1st month and 2nd month when pet therapy was applied, and twice in the two-month follow-up after the pet therapy application was terminated.

  16 week

• De Jong Gierveld Loneliness Scale

  The scale was first developed by De Jong Gierveld and Kamphuis in 1985. The Turkish adaptation of the scale with factor loadings between 0.64-0.86 was carried out by Çavdar, Bağcı, Chorbaci, Saritas and Tasdelen in 2015. Social loneliness and emotional loneliness two sub-scale in size 11 items in Scale. It is a four-point likert (4=Very convenient, 3=Convenient, 2=Not convenient, 1=Not convenient at all) type scale. Since the items in the social loneliness dimension contain positive statements, these items are reverse items. As the score obtained from the scale increases, the levels of loneliness increase. Before the research, 5 measurements were made, twice in the 1st month and 2nd month when pet therapy was applied, and twice in the two-month follow-up after the pet therapy application was terminated.

  16 week

• Subjective Happiness Scale (SHS)

  Developed by Lyubomirsky and Lepper, SHD is a seven-point Likert type, self-report style. The scale consists of four items; Since the fourth item contains a negative statement, this item is the reverse item. The lowest score taken from the scale is four, the highest score is 28, and as the individual's scale score increases, the level of happiness increases. Before the research, 5 measurements were made, twice in the 1st month and 2nd month when pet therapy was applied, and twice in the two-month follow-up after the pet therapy application was terminated.

  16 week

• End Stage Renal Disease (ESRD)-Adherence Questionnaire

  This scale was developed by Kim, Evangelista, Phillips, Pavlish, and Kopple. The ESRD-Adaptation Scale consists of four compliance behaviors subscales: participation in treatment (1st, 3rd and 5th items), medicine use (6th item), fluid restriction (8th item), and dietary restriction (9th item). Items 2, 5 and 7 of the items do not have a point value. The range of scores that can be obtained from the scale is between 0-1200, and as the score increases, the compliance of the patients with the treatment also increases. Before the research, 5 measurements were made, twice in the 1st month and 2nd month when pet therapy was applied, and twice in the two-month follow-up after the pet therapy application was terminated.

  16 week

• Dialysis Symptom Index (DSİ)

  Weisbord et al. has a total of 30 items in which both emotional and physical symptoms of dialysis patients and the severity of these symptoms are evaluated. After the patients answered yes-no to the questions regarding the symptoms they experienced within a week, their symptoms with a yes answer are re-evaluated in a five-point Likert type ("5 points: A lot", "4 points: Very little", "3 points: Sometimes", "2 points: A little", "1 point: Not at all"). The total score to be obtained from the scale ranges from 0 to 150. Before the research, 5 measurements were made, twice in the 1st month and 2nd month when pet therapy was applied, and twice in the two-month follow-up after the pet therapy application was terminated.

  16 week

Study Arms (3)

Robotic Pet Therapy/Robot Cat Group

EXPERIMENTAL

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".

Other: Robotic Pet Therapy/Robot Cat Group

Pet Therapy/Betta Fish Group

EXPERIMENTAL

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".

Other: Pet Therapy/Betta Fish Group

Control Group

NO INTERVENTION

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".

Interventions

Robotic Pet Therapy/Robot Cat Group 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.

Robotic Pet Therapy/Robot Cat Group

Pet Therapy/Betta Fish Group 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.

Pet Therapy/Betta Fish Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Tecnical University

Trabzon, 61800, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35932699 DERIVED

MeSH Terms

Interventions

Animal Assisted Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Ph.D

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 21, 2022
• Study Start: May 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)