Aim of this study is the effect of virtual reality on anxiety and vital signs of patients during coronary angioplasty.
Design
This is a randomized controlled trial study. Patients who candidate for femoral angioplasty in the first time, appropriate consciousness and without motion sickness and life threatening conditions are assigned in two groups according to randomized block design. In intervention group, before femoral needling in angioplasty, virtual reality film are playing for 15 minutes that contain nature pictures and light music. In control group there is not any intervention. Patients anxiety are measured with spielberger questionnaire before and after the angioplasty.
Settings and conduct
This study is performed in Valiasr hospital in Qom city. Persons who is measured the patients anxiety are not aware of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-80 years; appropriate consciousness; angioplasty through femoral artery.
Exclusion criteria: History of angioplasty; life threatening conditions; motion sickness
Intervention groups
Intervention group: Playing virtual reality film related to nature and light music for 15 minutes during angioplasty before needle insertion to femoral artery.
Control group: Routine interventions are performed during angioplasty.
Main outcome variables
Stat and trait anxiety score
Blood pressure, Heart rate, Arterial oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006481N13
Registration date:2020-11-10, 1399/08/20
Registration timing:registered_while_recruiting
Last update:2020-11-10, 1399/08/20
Update count:0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality on anxiety and vital signs of patients during coronary angioplasty.
Public title
Effect of virtual reality on anxiety of patients during angioplasty.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consciousness appropriate to cooperate
Angioplasty through femoral artery
Exclusion criteria:
History of angioplasty
Life threatening conditions
Motion sickness
Age
From 18 years old to 80 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
Randomization is done using stratified permuted block randomization. Patients are divided into two strata of male and female. For each stratum, a separate random assignment continues to reach the sample size. For random assignment in each stratum, four blocks of (A, B), which include different states of test and control sequences (AABB, ABAB …), are used. Block selection is done according to a random digits table.
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
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی سمنان
Street address
Semnan university of medical sciences, Shahid Akhlaghi intersection, Basij Blvd.,Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC.1399.192
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stat and trait anxiety
Timepoint
15 minutes before and 15 minutes before angioplasty
Method of measurement
Spielberger anxiety questionnaire
2
Description
Vital signs
Timepoint
15 minutes before, during and 10 minutes after angioplasty
Method of measurement
Ward monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Playing virtual reality contain pictures of nature and light music for 15 minutes during angioplasty.
Category
Prevention
2
Description
Control group: Routine intervention is performed during angioplasty.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Hamid Bahramian
Street address
Semnan university of medical sciences, 5th Km of Damghan road, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3335 4190
Email
Soli257@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Street address
Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3335 4190
Email
Soli257@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 1335 4192
Fax
+98 23 1335 4191
Email
soli257@sem-ums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 1335 4192
Fax
+98 23 1335 4191
Email
soli257@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 1335 4192
Fax
+98 23 1335 4191
Email
soli257@semums.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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