Determining and comparing the effects of distraction through virtual reality glasses with aromatherapy during angiography on patients' pain and anxiety
Design
A randomized, double-blind clinical trial with two intervention groups and one control group.
Settings and conduct
The location of this study is the Angiography Department of Ali Ibn Abi Taleb Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, stable hemodynamic status (no cardiac dysrhythmias and MI, arterial blood oxygen saturation greater than 80%), age range 25 to 60 years, first-time angiography. Exclusion criteria: hearing, vision, and smell impairment, mental disorders, use of sedatives.
Intervention groups
Demographic and Spielberger Anxiety Questionnaires will be completed 15 minutes before the patient enters the angiography room. In the virtual reality group, patients will wear virtual reality goggles 10 minutes before and during the angiography. The displayed content will include a relaxing environment with soft music. In the aromatherapy group, patients will inhale the scent of lavender oil through a pad soaked in 3 drops of lavender oil that is attached to the patient's collar 10 minutes before and during the angiography. In the control group, patients will not receive any intervention and will undergo angiography according to the usual hospital procedure, except that the goggles without the film will be used as a placebo. Immediately after the angiography is completed, the Spielberger Anxiety Questionnaire will be completed again, and the patient's pain will also be measured with a numerical pain scale.
Main outcome variables
Pain
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N26
Registration date:2025-05-20, 1404/02/30
Registration timing:prospective
Last update:2025-05-20, 1404/02/30
Update count:0
Registration date
2025-05-20, 1404/02/30
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-20, 1404/03/30
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of distraction through virtual reality glasses and aromatherapy during angiography on patients' pain and anxiety
Public title
Comparing the effects of distraction through virtual reality glasses and aromatherapy during angiography on patients' pain and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Performing angiography for the first time
Stable hemodynamic status (no cardiac dysrhythmias or MI, arterial blood oxygen saturation greater than 80%)
Age range 25 to 60 years
Exclusion criteria:
Hearing, vision, or smell impairment
Mental disorders
Taking sedatives
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected by convenience sampling, and then eligible patients meeting the inclusion criteria were divided into one of three groups: virtual reality, aromatherapy, or control through block random assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is impossible to completely blind the participants in the study due to the specific scents of the oils used in aromatherapy and the use of glasses. In this study, to ensure the accuracy and precision of the assessments, the pain and anxiety assessor will be completely blinded. This person will have no knowledge of the type of treatment each patient receives and his only task will be to assess the level of pain and anxiety of the patients based on their reports. The assessments will be carried out using standard pain and anxiety questionnaires that will be completed anonymously and without any reference to the type of treatment. Also, the data analyst will not know the names of the groups because the names of the groups in the SPSS software will be written from number 1 to 3 and the original names of the groups will not be written.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2025-05-14, 1404/02/24
Ethics committee reference number
1404.016.IR.RUMS.REC
Health conditions studied
1
Description of health condition studied
Pain and anxiety caused by angiography
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Anxiety
Timepoint
15 minutes before and immediately after completion of angiography
Method of measurement
Spielberger Anxiety Questionnaire
2
Description
Pain
Timepoint
immediately after completion of angiography
Method of measurement
Numeric Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the virtual reality group, patients wore virtual reality goggles 10 minutes before and during the angiography. The content displayed included a relaxing environment with soft music.
Category
Treatment - Other
2
Description
Intervention group: In the aromatherapy group, patients inhale the scent of lavender oil 10 minutes before and during the angiography through a pad soaked in 3 drops of lavender oil that is attached to the patient's collar.
Category
Treatment - Other
3
Description
Control group: In the control group, patients do not receive any intervention and undergo angiography according to the hospital's usual procedure, with the difference that glasses without a film will be used as a placebo.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitalib Rafsanjan Hospital
Full name of responsible person
Majid Kazemi
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7851656491
Phone
+98 34 3428 0097
Email
dr.kazemi.n@rums.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vaziri nejad
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazemi.n@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazemi.n@ruma.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazemi.n@rums.a.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
dr.kazemi.n@rums.a.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