Determining and comparing the average pain score and anxiety of open heart surgery patients before and after the intervention in the intervention and control groups
Design
The clinical trial has a control group, with a parallel group, randomized on 100 patients. Blocking of 4 will be used for randomization.
Settings and conduct
In the open heart special care department, the day after the operation, patients who meet the inclusion criteria will be included in the study. For the intervention group, virtual visualization will be performed with the help of special glasses, while the control group will receive routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: full consciousness (relative to place, time and person); RASS +1 to -1; having sinus rhythm during the intervention.
Non-entry criteria: receiving anti-anxiety or sedative drugs 24 hours before and after the intervention.
Intervention groups
In the intervention group, a game based on virtual reality will be implemented with the help of glasses for the patients of the intervention group.
The control group will receive routine ward care.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111203008286N11
Registration date:2022-08-29, 1401/06/07
Registration timing:registered_while_recruiting
Last update:2022-08-29, 1401/06/07
Update count:0
Registration date
2022-08-29, 1401/06/07
Registrant information
Name
Fatemeh Bahramnezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fatemeh_bahramnezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality-based play therapy on pain intensity and anxiety in patients with open heart surgery
Public title
Virtual reality-based play therapy on pain and anxiety in patients with open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Full awareness (relative to place, time and person)
RASS +1 to -1
Having sinus rhythm during intervention
Exclusion criteria:
Occurrence of anxiety symptoms such as fear of closed spaces
History of neurological disorders (such as movement, vision and hearing disabilities)
Use of respiratory equipment such as artificial respiration
Receiving anti-anxiety or sedative drugs 24 hours before and after the intervention
Severe dysfunction of non-cardiovascular systems (for example, chronic renal failure)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In the sampling method, samples with inclusion criteria will be divided into two test and control groups by random allocation by block method. In this way, the research samples will be randomly placed in blocks of four, and to form these blocks of four, cards are used that have already been placed in four blocks by the computer randomly into two test and control groups.
In this way, in each block of 4, two control samples and two test samples are placed with random permutations. In this study, 33 blocks of 4 blocks will be allocated according to 90 research samples. For example, in the first block of 4, volunteer number one will be in the control group (B) and volunteer number two will be in the control group (A).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Boulevard, Quds corner
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.TUMS.FNM.REC.1401.025
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Pain
Timepoint
Before, one month after
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Anxiety
Timepoint
Before, one month after
Method of measurement
Spielberger questionnaire
Intervention groups
1
Description
Intervention group: using virtual reality with the help of 3D glasses In this case, the day after the surgery, the patient will put the special glasses on his eyes for 20 minutes and first he will see a forest with the sound of birds. Then he will cross this path and enter a The environment becomes snowy, in this case, you have to put snowballs on top of each other and make a snowman. By making a snowman, if there is no error, his page will become a rain star.
Category
Rehabilitation
2
Description
Control group: In this group, no intervention is done for the patient and the patient will only receive routine ward care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital (RA) Tehran
Full name of responsible person
FatemehBahramnezhad
Street address
Nosrat st. Tohid sq.
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4416
Email
bahramnezhad.f@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
6th Floor, Research and Technology Vice-Chancellor, Corner of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4125
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Street (Nusrat East), Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4416
Email
bahramnezhad.f@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Street (Nusrat East), Tohid Square, Tehran, Iran
City
Tehan
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4416
Email
bahramnezhad.f@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani Street (Nusrat East), Tohid Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4416
Email
bahramnezhad.f@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Some information about the primary data is releasable
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Researchers working in academic departments
Under which criteria data/document could be used
Secondary analysis
From where data/document is obtainable
E-mail: bahramnezhad.f@gmail.com
What processes are involved for a request to access data/document