Determination and comparison of the effect of sedative images based on virtual reality and rhythmic breathing on anxiety and physiological indices of candidates for coronary angiography
Design
Clinical trial with three intervention and parallel groups, single blind and randomized with a sample size of 60 people
Settings and conduct
This single-blind clinical trial will be performed on patients undergoing coronary angiography in the cardiac care.After applying the inclusion criteria and purposive Sampling, Patients will be divided into three groups by simple random sampling.Group 1: Respiratory technique by the Suha Pranayama method, Group 2: Relaxation images using virtual reality and Group III: Control group.The intensity of anxiety will be measured using a Spielberger standard questionnaire and physiological indicators using a monitoring device.Variables will be measured in each of the three groups before intervention, half an hour after intervention.Measurement of anxiety intensity and physiological indicators will be done by the uninformed researcher of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Hemodynamic status stability
Age over 18 years
No history of previous coronary angiography
Non-inclusion criteria:
Hearing and visual impairment
Presence of mental disorders
The use of sedatives or anti-anxiety medications within 72 hours prior to the intervention
Drug addiction
Exclusion criteria:
Disturbance and instability in vital signs during the study
Patient's deterioration during the study
Intervention groups
Patients will be divided into three groups.The first group will receive respiratory intervention.The second group will receive virtual reality intervention.The third group will be considered as the control group.
Main outcome variables
Anxiety intensity
Physiological Indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150106020581N3
Registration date:2019-04-26, 1398/02/06
Registration timing:retrospective
Last update:2019-04-26, 1398/02/06
Update count:0
Registration date
2019-04-26, 1398/02/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
abbasi.ali@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of virtual reality and rhythmic breathing on anxiety and physiologic indices of patients candidate for coronary angiography
Public title
Compare the effectiveness of virtual reality and rhythmic breathing on anxiety and physiologic indices of patients candidate for coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Stable hemodynamic status
Be alert
The first time performing coronary artery angiography
Exclusion criteria:
Opioid addiction
Psychopathy
Hyperthyroidism and respiratory problems
Hearing and vision defects
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation of patients to the three groups of virtual reality, breathing techniques and control will be performed using permutation block.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data collection will be conducted by other researchers (researcher blinding)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan university of medical sciences
Street address
Administrative complex of University of Medical Sciences, Khalij Fars blvd, Dr Hesabi square, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.ZAUMS.REC.1397.435
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Physiologic indices
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety intensity
Timepoint
Before intervention.Half an hour after intervention.
Method of measurement
State-Trait Anxiety Inventory
2
Description
Systolic blood pressure
Timepoint
Before intervention.Half an hour after intervention.
Method of measurement
CardioSet LX110 monitoring device
3
Description
Diastolic blood pressure
Timepoint
Before intervention.Half an hour after intervention.
Method of measurement
CardioSet LX110 monitoring device
4
Description
Heart rate
Timepoint
Before intervention.Half an hour after intervention.
Method of measurement
CardioSet LX110 monitoring device
5
Description
Respiratory rate
Timepoint
Before intervention.Half an hour after intervention.
Method of measurement
CardioSet LX110 monitoring device
6
Description
Percentage of saturated oxygen in the blood
Timepoint
Before intervention.Half an hour after intervention.
Method of measurement
CardioSet LX110 monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The respiratory technique will be performed by the Sukha Pranayama method.In this method, the subjects sit on the chair and perfectly relax themselves.Then they close their eyes and ask them to think nothing but the process of breathing.We ask the patient to inhale and exhale slowly and regularly do.Inhale and exhale through the nostrils will be done.The patient will be asked to bring energy into the lungs during the inhalation and expel tension, stress and illness during exhalation.Each breathing phase will last for 5 seconds, and a total respiratory cycle will last 10 seconds.6 breaths per minute will be implemented.This breathing technique will run for 5 consecutive minutes.
Category
Rehabilitation
2
Description
Intervention group: In this group virtual reality intervention will be implemented.For patients, sedation images will be displayed for 5 minutes using the virtual reality camera.
Category
Rehabilitation
3
Description
Control group: Patients in the control group will receive routine care prior to angiography.Measurement of variables such as patients in the intervention group will be done in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebn abitaleb hospital
Full name of responsible person
Faezeh Pouryousef
Street address
Ali ebn abitaleb hospital, Slamat Blvd, Persian Gulf Highway, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
fpouryousef@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr noormuhammad bakhshani
Street address
Zahedan University of Medical Sciences, Khalije Fars Blvd, Dr Hesabi Square, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Phone
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Faezeh Pouryousef
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd, Faculty of Nursing and Midwifery, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
fpouryousef@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Faezeh Pouryousef
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd, Faculty of Nursing and Midwifery, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
fpouryousef@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Faezeh Pouryousef
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Behdasht blvd,Faculty of Nursing and Midwifery, Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
fpouryousef@yahoo.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
Undecided - It is not yet known if there will be 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