Comparison of the effect of virtual reality, music therapy and aromatherapy on the anxiety of patients hospitalized in CCU
Design
A controlled ,randomised,blinded, clinical trial with 3 parallel study groups designed of 100 patients
Settings and conduct
Place of the intervention is the CCU department of Imam Khomeini Hospital. Four groups of 25 people who are randomly divided are selected, all four groups complete the Spielberger questionnaire immediately before the intervention. After that, the intervention is carried out in the three intervention groups, and then after a 20-minute break after the intervention, all three intervention groups and the control group complete the Spielberger questionnaire again. And finally, the information obtained from the four groups are compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: age being over 18 years؛ being aware of time, place and people; having consented and completed a written consent form; having a healthy sense of hearing; not being sensitive to specific smells, including perfume, cologne or a special flower; no respiratory problem; no history of mental illness, depression or anxiety that has been diagnosed by a psychiatrist and no history of a new crisis such as: death of a first degree relative or divorce.
Intervention groups
First Intervention group: Virtual reality, using special virtual reality glasses, they see relaxing images for 15 minutes
Second Intervention group: The music group for 15 minutes of silent music under the title ((Soft silent mix)) downloaded from the site nicmusic.net
Third Intervention group: The aromatherapy group also smells the essential oil of Bahar Naranj plant produced by Adonis Gol Daru company for 15 minutes.
Control group: does not receive any intervention
Main outcome variables
Patient's anxiety score in Spielberger questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240609062060N1
Registration date:2024-09-18, 1403/06/28
Registration timing:prospective
Last update:2024-09-18, 1403/06/28
Update count:0
Registration date
2024-09-18, 1403/06/28
Registrant information
Name
Abbas Rezaie
Name of organization / entity
Khomein University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4622 4142
Email address
rezaieemail1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-05, 1403/07/14
Expected recruitment end date
2024-11-10, 1403/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation of virtual reality, music therapy and aromatherapy on anxiety in cardiac care unit patients
Public title
Effect of virtual reality, music therapy and aromatherapy on anxiety in cardiac patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years of age
Being aware of time, place and people
Having informed consent and completing a written consent form
Having a healthy sense of hearing
Not being sensitive to specific smells, including the smell of perfume, cologne, or specific flowers
Not having any Respiratory problems
No history of mental illness, depression or anxiety that has been diagnosed by a psychiatrist
No history of new crisis such as death of 1st degree relatives, divorce of self or parents in the last 6 months
Exclusion criteria:
Patient's refusal to continue participating in the study
The virtual reality, music therapy or aromatherapy becomes unpleasant for the patient
patient's condition becomes critical
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on the table of random numbers.In this way, in the beginning, all the research units were numbered, then the RandBetween function was used by Excel software,and between the number 1 and 100 ,random numbers were obtained,and then the first 25 random numbers in the first study group, the second 25 random numbers in the second study group ,the third 25 random numbers in the third study group and the fourth 25 random numbers are placed in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The research units are unaware of the type of intervention in other groups.The data analyst also has access to the raw data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khomein Univercity of Medical Sciences
Street address
Azadi Blvd.,Khomein town
City
Khomein
Province
Markazi
Postal code
3881743364
Approval date
2024-08-31, 1403/06/10
Ethics committee reference number
IR.KHOMEIN.REC.1403.015
Health conditions studied
1
Description of health condition studied
Stress of patients Hospitalised in cardiac care unit
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient's anxiety score in Spielberger questionnaire
Timepoint
Before the intervention and 20 minutes after the intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Virtual reality,including 25 patients after completing Spielberger questionary by using special virtual reality glasses, they see relaxing images for 15 minutes, and after 20 minutes break they complet the Spielberger questionary for the second time.
Category
Other
2
Description
Second Intervention group: The music group including 25 patients after completing Spielberger questionary for 15 minutes they listen to silent music under the title ((Soft silent mix)) downloaded from the site nicmusic.net and after 20 minutes break they complet the Spielberger questionary for the second time.
Category
Other
3
Description
Third Intervention group: The aromatherapy group including 25 patients after completing Spielberger questionary smell the essential oil of Bahar Naranj plant produced by Adonis Gol Daru company for 15 minutes.and after 20 minutes break they complet the Spielberger questionary for the second time.
Category
Other
4
Description
Control group: does not receive any intervention they complete the Spielberger questionnaire two times with 35 minutes interval
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Ramin Ronassi
Street address
Shahid beheshti Blvd, Khomein town
City
Khomein
Province
Markazi
Postal code
۳۸۸۱۹۵۵۵۳۳
Phone
+98 86 4633 2211
Email
info@khomeinums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khomein Faculty of Medical Science
Full name of responsible person
Abbas Farahani
Street address
Azadi Blvd.,Khomein town
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
info@khomeinums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein Faculty of Medical Science
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
Khomein University of Medical Sciences
Full name of responsible person
Abbas Rezaie
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Azadi Blvd.,Khomein town
City
Khomein
Province
Markazi
Postal code
۳۸۸۱۷۴۳۳۶۴
Phone
+98 86 4622 4142
Fax
Email
rezaieemail1994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Abbas Rezaie
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Azadi Blvd.,Khomein town
City
Khomein
Province
Markazi
Postal code
۳۸۸۱۷۴۳۳۶۴
Phone
+98 86 4622 4142
Fax
Email
rezaieemail1994@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Abbas Rezaie
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Azadi Blvd.,Khomein town
City
Khomein
Province
Markazi
Postal code
۳۸۸۱۷۴۳۳۶۴
Phone
+98 86 4622 4142
Fax
Email
rezaieemail1994@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
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