Clinical trial NCT06458608: Hemodiasis Patients Using Virtual Reality Video
Official title: Determining the Effect of Virtual Reality-Based Videos on Hemodialysis Symptoms, Vital Signs and Comfort in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Symptoms
Virtual Reality
Comfort
Keywords: Hemodialysis, Virtual Reality Symptoms, Vital Signs, Comfort
Lead sponsor: Gümüşhane Universıty
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: No study could be taken as a reference due to the number of samples, the amount of error in the G\*Power 3.1.9.6 program, α=0.05, and the lack of a previous study with 2 groups on the subject; With an effect size of 0.80 and the power of the targeted test being 0.80 (80%), a total of 42 patients (21 for each group) were calculated for two groups (experimental group, control group). Considering situations such as wanting to leave the study or death during the research, each group will be increased by 20% and a total of 50 patients will be included in the study, 25 patients for each group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: VR, with its developing technology, is a new technique used in the healthcare industry combined with cognitive technology to reduce the symptoms experienced by patients and to relieve the patient. This study investigates whether virtual tour environments created using virtual reality glasses have an effect on patients\&#39; vital signs, symptoms and comfort during the hemodialysis session. It is aimed to evaluate the effect of Virtual Reality Based Videos applied during hemodialysis treatment on Hemodialysis Symptoms, vital signs and Comfort.

Detailed description: Hemodialysis (HD) is one of the treatment options used to regulate renal functions in the treatment of chronic renal failure. In hemodialysis, patients have to cope with many problems during the treatment process as well as the disease. In addition, patients require HD treatment, which lasts three to four hours, three times a week on average. Factors such as having to go to a dialysis center for these treatments, patients having to continue their lives depending on the machine, restriction of movements during the session, increased dependency of the patient, deterioration in their adaptation to professional and social relationships affect the patients\&#39; daily life activities and reduce their comfort. With the developing technology, virtual reality, a new technique in the healthcare industry, has begun to be used in nursing care in order to reduce the symptoms experienced by patients and to comfort the patient.

The virtual reality device removes the patient from the environment with the glasses and headphones attached to the person\&#39;s head, along with the image on the screen and simultaneous sounds, and focuses his/her attention on the virtual video images. This study was planned as a randomized controlled study to evaluate the effect of virtual reality-based videos on hemodialysis symptoms and comfort in hemodialysis patients. The research was planned to be conducted with 50 hemodialysis patients. \&#34;Patient Introduction Form\&#34;, \&#34;Dialysis Symptom Index (DSI)\&#34;, \&#34;Vital Signs Monitoring Form\&#34;, \&#34;Hemodialysis Comfort Scale Version II\&#34; will be used to collect data. After the scales were applied, patients in the experimental group were exposed to virtual reality glasses for 30 minutes, twice a week for 8 weeks. The video will be watched. At the end of 8 weeks, the scales will be applied again and compared with the initial scale results.

As a result, in line with the findings obtained from the research, the effect of virtual reality application on dialysis symptoms, vital signs and comfort during hemodialysis treatment will be determined and suggestions will be made to encourage patients to use virtual reality methods in the environments where they are treated.

Eligibility criteria: Inclusion Criteria:

- Voluntarily over 18 years

Exclusion Criteria:

* reluctant

Primary outcomes:
measure: Hemodialysis Comfort Scale Version II (HDCS Version II)
timeFrame: 8 week
Secondary outcomes:
measure: Dialysis Symptom Index (DSI) (Appendix 2)
timeFrame: 8 week
measure: Vital Signs Monitoring Form
timeFrame: 8 week
Other outcomes:
Locations:
city: Gümüşhane
country: Turkey
facility: Gümüşhane Üniversitesi
state: Kelkit
Study officials:
affiliation: Gümüşhane Universıty
name: Dilan aktepe coşar
role: PRINCIPAL_INVESTIGATOR
References: