Effectiveness of Virtual Reality Therapy on Hospital Anxiety and Depression and Patients' Stress Before Open Heart Surgery
Design
This clinical trial is a single-blind intervention and control group.
Settings and conduct
Content of treatment sessions
Introduction to Virtual Reality Therapy / Relaxation Training / Presentation and Pre-Test
Running forest and mountain virtual reality software
Run the sea virtual reality software
Running nature's virtual reality software
Re-run forest and mountain virtual reality software
Reboot Virtual Reality Software
Re-run nature's virtual reality software
The test will be carried out at the Specialty Heart Center of Martyr Dr. Chamran Isfahan.
Participants/Inclusion and exclusion criteria
Entry criteria:
Waiting for open heart surgery
- Age 40 - 50
- Reading and writing skills
Exit Criteria:
- The patient is diagnosed with acute psychiatric disorders
- unwillingness to attend treatment sessions
- Missing more than two sessions
Intervention groups
Sample size In the sampling, 30 people were selected by available sampling and randomly assigned into two experimental (n = 15) and control (n = 15) groups.
After assigning the subjects to the two experimental and control groups, the experimental group will receive 8-minute virtual reality therapy sessions while the control group will receive no intervention. All subjects will complete the research questionnaires once before the intervention, once thereafter and once after 7 days. The summary of the Virtual Reality Therapy content is given in the table below.
The Effectiveness of Virtual Reality Therapy on Hospital Anxiety and Depression and Patient's Stress Before Open Heart Surgery
Public title
The Effectiveness of Virtual Reality Therapy on Hospital Anxiety and Depression and Patient's Stress Before Open Heart Surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-50 years
Reading and writing skills
Waiting for open heart surgery
Exclusion criteria:
Out of age 40-50 years
Illiteracy
Acute mental disorders diagnosed by a psychiatrist or psychologist
Absence in medical sessions more than 2 times
Age
From 40 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized selection of the intervention and control groups is simple random.This random selection is obtained from the list of patients available at the hospital admission.
Blinding (investigator's opinion)
Single blinded
Blinding description
For this process, the patient's name is not mentioned on the questionnaire and the other person collects the data except the researcher who does the treatment.
Placebo
Not used
Assignment
Other
Other design features
Using Virtual Reality Technology in the Treatment of Stress, Anxiety and Depression
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
Sheikh Mofid Street. Alley 20. Plate 34
City
Isfahan
Province
Isfehan
Postal code
9164960858
Approval date
2020-01-08, 1398/10/18
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.255
Health conditions studied
1
Description of health condition studied
Hospital Depression - Hospital Anxiety - Stress
ICD-10 code
ICD-10 code description
F40
Primary outcomes
1
Description
Hospital Anxiety-Hospital Depression-Stress
Timepoint
All subjects will complete the follow-up questionnaires once before the intervention, once after the intervention and once after 7 days after open heart surgery.
Method of measurement
The method of measurement is done by questionnaire. Two questionnaires are DASS-21 and HADS.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: 15 patients are waiting for open heart surgery with 7 sessions of treatment.
Category
Treatment - Devices
2
Description
Control group: Fifteen patients are awaiting open heart surgery with no cure.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Chamran Specialty Heart Hospital
Full name of responsible person
Sanaz Ahmadi
Street address
Sheikh Mofid Street. Alley 20. No. 34
City
Isfahan
Province
Isfehan
Postal code
8164960858
Phone
+98 31 3661 0668
Email
sanaz.ahmadi.psychology@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
gholamreza manshaee
Street address
Khorasgan area. Arghavaniyreh Street. Isfahan Islamic Azad University (Khorasgan)