Effect of virtual reality application on pain associated with chest tube removal after Coronary Artery Bypass Graft
Design
Clinical trials with intervention and control group, with parallel groups, randomized by binary blocks, 30 persons per group
Settings and conduct
The patients eligible for admission to the ICU and post ICU sections of Emam Reza and Ghaem Hospital. In the intervention group, the deviant techniques are implemented by the virtual reality headset. The list includes 5 video 360 degrees and the video is played through the virtual reality app 5 minutes before the chest tube is removed. At the end of the fifth minute, the nurse will remove the chest tube in a few seconds. In the control group, routine care is being performed. The pain intensity scale (VAS), before, immediately, and 15 minutes after tube withdrawal, and pain quality are measured by the modified McGill form before and 15 minutes later.
Participants/Inclusion and exclusion criteria
Inclusion criteria:People aged 18-70 years undergoing open heart surgery؛ who have a mediastinal or pericardial chest tube؛ are now alert؛ are not attached to the ventilator؛ do not receive sedation؛ do not have severe vision or hearing problems؛ also They tend to cooperate in this study؛ Exclusion criteria: If the patient has unstable hemodynamic conditions, they will not be included in the study
Intervention groups
In the intervention group at the time of removal of the chest tube, the technique is performed by the virtual reality headset and performed in the routine care control group (mid-sit position, deep breath and chest tube withdrawal by nurse in a few secretions) and There is no other intervention
Main outcome variables
The severity and quality of pain resulting from the removal of the chest tube in patients undergoing coronary artery bypass graft surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044147N1
Registration date:2019-08-26, 1398/06/04
Registration timing:registered_while_recruiting
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Fateme Seddighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3609 1744
Email address
seddighif951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-01, 1398/05/10
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of virtual reality application on pain associated with chest tube removal after cardiac surgery
Public title
Effect of virtual reality application on pain associated with chest tube removal after cardiac surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have Iranian nationality
Be Muslim
Satisfied to participate in the study
Age of more than 18 years and under 70 years
Have enough eyesight with or without glasses
Ability to speak Persian
Minimum reading and writing literacy
Awareness is sufficient to determine the severity and quality of the pain
Heart disease (CABG)
Have a pericardium or mediastinum tube
Have not a companion disease that affects pain assessment (delirium, dementia, severe depression)
Has not received an injectable soothing medicine from the previous 4 hours
Do not have severe visual impairment and hearing loss
Do not connect to the ventilator
Exclusion criteria:
The patient does not have stable hemodynamic status
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The referred persons are assigned to the intervention and control groups by their entry into binary blocks. The allocation will be done by the PASS software
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 Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Daneshgah Street, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.027
Health conditions studied
1
Description of health condition studied
pain associated with chest tube removal after cardiac surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity score at the Visual Analogue Scale
Timepoint
The severity of pain in the three stages (before, immediately and 15 minutes after the removal of the chest tube)
Method of measurement
Visual Analogue Scale
2
Description
Pain quality score in McGill questionnaire
Timepoint
Before and 15 minutes after the chest tube exits
Method of measurement
McGill questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the techniques are implemented by the virtual reality headset. First, a description of the method of intervention is given to the patient, then a list of 5 video 360 degrees with nature content and at least 5 minutes is provided to the patient to be selected to play a video. After selecting the video, the smartphone is placed inside the headset and the selected video is played back through the virtual reality app. From the 5 minutes before the breastbone is removed, the headset is placed on the patient and the video is played back. At the end of the fifth minute, the nurse steps out the chest tube according to the standard method, and after the video goes out, the video player stops and the glasses are removed from the patient's eyes.
Category
Rehabilitation
2
Description
Control group: Common care includes half-sitting position and deep breathing
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Tayyebi Mohammad
Street address
Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Boostani Reza
Street address
Beginning at Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Mashhad University of Medical Sciences, Opposite Daneshgah Street 18, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 2081
Email
vcresearch @ mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dalir Zahra
Position
teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Ebne Sins Street, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1513
Email
DalirZ@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dalir Zahra
Position
teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 513859151
Email
DalirZ@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seddighi Fateme
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 233, Seyyed razi51 street, Seyyed Razi Blve, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9188165965
Phone
+98 516031744
Email
seddighif951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome measures of pain before and after the intervention, and side effects including pre- and post-intervention anxiety and stress, and pre-intervention fatigue, and information on the location of chest tube placement
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
In order to use the method of project implementation in other similar research and to cite the existing plan by researchers and students of academic institutions
From where data/document is obtainable
Central Library of Mashhad School of Nursing and Midwifery
What processes are involved for a request to access data/document
The data request will be sent to the responsible author's email and will be sent as soon as possible by the responsible author of the file.