Protocol summary

Study aim
Determining the effect of using virtual reality on happiness and quality of life of elderly people undergoing hemodialysis
Design
This study is implemented in a crossover manner. The first group is exposed to watching 3D 360-degree virtual reality movies on the theme of entertainment and recreation (travel, tourism and pilgrimage) using a virtual reality headset. This intervention is performed for 10-15 minutes and 3 times a week. The second group will also watch VR films in the same way, with a relaxing and exciting axis. After a 2-week washout period to clear the intervention effect, the content of the VR films will be switched between the two intervention groups over the next 4 weeks.
Settings and conduct
Hemodialysis Department of Razi Educational and Medical Center, Rasht
Participants/Inclusion and exclusion criteria
The inclusion criteria for this study included: age 65 years and older, diagnosis of ESRD, having a minimum duration of hemodialysis of 3 months, having at least 3 hemodialysis sessions per week, willingness and informed consent to participate in the research project, having the ability to speak and communicate Non-entry criteria included: Severe cognitive impairment, visual or hearing impairments, previous experience with VR technology, severe visual and hearing problems, musculoskeletal problems in the head and neck area, a history of severe and frequent headaches and migraines, having malignant diseases such as cancer and neurological and psychiatric diseases and epilepsy such that the patient is under treatment, a history of taking antidepressants and having other physical diseases except diabetes and hypertension.
Intervention groups
In this study, there are two intervention groups (1 and 2) that are implemented using a simple random allocation method, a crossover design.
Main outcome variables
Happiness and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190315043062N4
Registration date: 2025-07-04, 1404/04/13
Registration timing: prospective

Last update: 2025-07-04, 1404/04/13
Update count: 0
Registration date
2025-07-04, 1404/04/13
Registrant information
Name
Azar Darvishpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4256 5060
Email address
darvishpour@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-01, 1404/06/10
Expected recruitment end date
2025-12-01, 1404/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Virtual Reality on Happiness and Quality of Life Among Elderly Hemodialysis Patients : A Randomized Controlled Trial
Public title
Impact of Virtual Reality on Happiness and Quality of Life Among Elderly Hemodialysis Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 65 years and older diagnosis of end-stage renal disease (ESRD) having a minimum duration of hemodialysis of 3 months having at least 3 hemodialysis sessions per week, willingness and informed consent to participate in the research project having the ability to speak and communicate obtaining a score of 7 or higher on the AMT tool to assess normal cognitive status
Exclusion criteria:
Severe cognitive impairment Visual or hearing impairments that prevent the use of VR Previous experience with VR technology Severe vision and hearing problems Musculoskeletal problems in the head and neck area, a history of severe and frequent headaches and migraines Malignant diseases such as cancer and neurological and psychiatric diseases and epilepsy such that the patient is under treatment History of taking antidepressants Physical diseases other than diabetes and hypertension
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, In this study, participants will be randomly assigned to one of the following two intervention sequences: Group A: Intervention 1 → Washout Period → Intervention 2 Group B: Intervention 2 → Washout Period → Intervention 1 To ensure equal allocation of participants to each sequence, a block randomization method with a fixed block size of 6 will be used. In total, 9 blocks of 6 will be considered to allocate 54 participants (27 per sequence) equally. The allocation sequence will be generated via the following website: https://www.sealedenvelope.com/simple-randomiser/v1/lists Participants will be allocated to one of the two sequences based on the order of entry into the study, according to the generated randomization list. To reduce bias, the randomization sequence will be generated and implemented by an individual independent of the research team who has no role in the data collection, assessment, or analysis process.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology., in front of the 17 Shahrivar Hospital., Shahid Siadati Street., Namjo Street
City
Rasht
Province
Guilan
Postal code
66949- 41466
Approval date
2025-06-25, 1404/04/04
Ethics committee reference number
IR.GUMS.REC.1404.139

Health conditions studied

1

Description of health condition studied
End stage renal disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease

Primary outcomes

1

Description
Happiness
Timepoint
Data will be collected in three stages: pre-test, post-test, and follow-up.
Method of measurement
Oxford Happiness Questionnaire

2

Description
Quality of Life
Timepoint
Data will be collected in three stages: pre-test, post-test, and follow-up.
Method of measurement
Kidney Patients Quality of Life Questionnaire (KDQOL-SF)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first group will be exposed to watching 360-degree virtual reality 3D movies in the entertainment and entertainment axis (travel, tourism and pilgrimage) using a virtual reality headset. This intervention will be done for 10-15 minutes and 3 times a week. After observing a 2-week time interval to clear the effect of the intervention, during the next 4-week period, the content of the virtual reality movies will be switched between the two intervention groups. After the end of the intervention, the follow-up period will be conducted within 2 weeks.
Category
Other

2

Description
Intervention group: The second group will be exposed to watching 360-degree virtual reality 3D movies in the relaxing and exciting axis using a virtual reality headset. This intervention will be done for 10-15 minutes and 3 times a week.After observing a 2-week time interval to clear the effect of the intervention, during the next 4-week period, the content of the virtual reality movies will be switched between the two intervention groups. After the end of the intervention, the follow-up period will be conducted within 2 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis Department, Razi Educational and Medical Center, Rasht
Full name of responsible person
Azar Darvishpour
Street address
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
City
Langeroud
Province
Guilan
Postal code
44771-66595
Phone
+98 13 4253 6263
Email
darvishpour_a@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramyar Farzan
Street address
Vice Chancellor for Research and Technology., in front of the 17 Shahrivar Hospital., Shahid Siadati Street., Namjo Street
City
Rasht
Province
Guilan
Postal code
66949- 41466
Phone
+98 13 3333 5821
Email
darvishpour_a@yahoo.com
Web page address
http://www.gums.ac.ir/research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Azar Darvishpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
City
Langeroud
Province
Guilan
Postal code
44771-66595
Phone
+98 13 4253 6263
Email
darvishpour@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Azar Darvishpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
City
Langeroud
Province
Guilan
Postal code
44771-66595
Phone
+98 13 4253 6263
Email
darvishpour@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Azar Darvishpour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Shahid Yaghoub Sheikhi Street., Leylakooh road., Langeroud
City
Langeroud
Province
Guilan
Postal code
44771-66595
Phone
+98 13 4253 6263
Email
darvishpour@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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