Hemodiasis Patients Using Virtual Reality Video

NCT06458608 | Completed

• 1 other identifier: Hm20240001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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\' 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.

Conditions

Hemodialysis; Symptoms; Virtual Reality; Comfort

Keywords

Hemodialysis, Virtual Reality Symptoms, Vital Signs, Comfort

Outcome Measures

Primary Outcomes (1)

• Hemodialysis Comfort Scale Version II (HDCS Version II)

  The scale consists of a total of 26 items and a 5-point Likert type. HDCS Version II has six subscales (physical relaxation, physical comfort, psychospiritual comfort, psychospiritual transcendence, environmental transcendence, and sociocultural comfort).

  8 week

Secondary Outcomes (2)

• Dialysis Symptom Index (DSI) (Appendix 2)

  8 week

• Vital Signs Monitoring Form

  8 week

Study Arms (2)

group that watched virtual reality videos

EXPERIMENTAL

Pre-test data for all participants before treatment in the waiting room of the hemodialysis unit, "Structured Patient Introduction Form" (Annex-1), "Dialysis Symptom Index (DSI)" (Appendix 2), "Vital Signs Monitoring Form" (Appendix). 3),''Hemodialysis Comfort Scale Version II'' (Appendix 4) face to face interview for approximately 15 minutes is run as learning pre-test data. The intervention group was also given information about the use of virtual reality and the video content to be watched. Videos are transferred to virtual reality glasses and presented with the headset. After the hemodialysis treatment starts, the intervention psychologist researcher will watch 30 scan videos of approximately half an hour during the dialysis period, 2 sessions a week for 8 weeks, and a Turkey promotional short film presented by the researchers visually and audibly in VR (VR Shineco 3d).

Device: virtual reality glasses

The group that is not allowed to watch virtual reality videos

EXPERIMENTAL

The hemodialysis patients in this group were not shown anything. Only data collection forms were administered to the patients before the study (pretest) and at the end of the study.

Device: virtual reality glasses

Interventions

virtual reality glasses DEVICE

virtual reality glasses

The group that is not allowed to watch virtual reality videos; group that watched virtual reality videos

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Voluntarily over 18 years

You may not qualify if:

• reluctant

Sponsors & Collaborators

• Dilan aktepe coşar: lead

Study Sites (1)

Gümüşhane Üniversitesi

Gümüşhane, Kelkit, 2900, Turkey (Türkiye)

Location

Study Officials

• Dilan aktepe coşar

  Gümüşhane Universıty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: hile 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: SPONSOR INVESTIGATOR
• PI Title: lecture

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: May 30, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

TU (1)