Comparison of the effectiveness of the world's top two technologies on reducing the level of anxiety and stress of patients
Design
Clinical trial with control group with randomized double-blind blind groups in 3 groups of 70 people
Settings and conduct
The patient's family in the cardiac ward will complete the questionnaires the night before the operation and receive routine training. They will be placed before the patient leaves the operating room and then by a constant but unfamiliar nurse with people before the patient leaves the stress and anxiety questionnaires will be completed and then the data will be processed by an unfamiliar analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: first-degree relativity with the patient. Having informed consent. Age 18-60. Be on the next day's operation list. ؛ Non-entry conditions: Causing neurological complications of headache and dizziness. vision or hearing problems . neurological and motion sickness.
Intervention groups
The first study group underwent virtual reality and routine training the night before surgery
The second study group underwent multimedia and routine training the night before surgery
The third study group as a control did only routine training the night before surgery
Main outcome variables
Determining the anxiety and stress of companions. Determining the effect of Multi Media on reducing anxiety and stress. Determining the effect of virtual reality on reducing anxiety and stress.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051552N1
Registration date:2022-01-29, 1400/11/09
Registration timing:prospective
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
roshanak eftekhar ardebili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 9148
Email address
r.eftekhar@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-04-04, 1401/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two methods of virtual reality and multimedia on the anxiety and stress in companions of patients underlying angiography
Public title
Comparison of the effect of virtual reality and multimedia methods on anxiety and stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First class patient family
Having conscious satisfaction
Age over 18 and under 60
Families of patients on the operation list the next day
Exclusion criteria:
Having effective vision and hearing problems in communication
Join the treatment team
Having neurological illnesses (for at least 6 months) and motion sickness
Age
From 18 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:
210
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population is randomly divided into 6 groups by triple blocking method. How to arrange the groups as ABC ACB BAC BCA CAB CBA by assigning each letter to each study group. These makeups will be placed inside a container. At each sampling, they will be randomly selected from inside the container and will be placed in a group according to the letter arrangement of each sample with the priority of the letters.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a regular nurse will be used to complete the questionnaires of the subjects who are not aware of the study group and also the data analyzer is not aware of the type of groups of individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Administrative complex of Ardabil University of Medical Sciences.,End of Daneshgah St.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2021-08-23, 1400/06/01
Ethics committee reference number
IR.ARUMS.REC.1400.166
Health conditions studied
1
Description of health condition studied
Stress and anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress score in Harry Stress Questionnaire
Timepoint
The sections of completing the questionnaire are the night before the operation and then tomorrow (the day of the operation) after the intervention with virtual reality and multimedia in the intervention groups before the patient leaves the operating room.
Method of measurement
Harry Stress Inventory Standard Questionnaire
2
Description
anxiety score in Speilberger Questionnaire
Timepoint
The sections of completing the questionnaire are the night before the operation and then tomorrow (the day of the operation) after the intervention with virtual reality and multimedia in the intervention groups before the patient leaves the operating room.
Method of measurement
The State-Trait Anxiety Inventory (Spielberger)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Virtual reality (people in this group received routine training by a regular nurse the night before the operation and the day of the operation after the patient enters the operating room will be under virtual reality with sedative content for 10 minutes and before The patient will leave the operating room and the questionnaires will be completed.)
Category
Prevention
2
Description
Intervention group 2: under multimedia (people in this group received routine training by a regular nurse the night before the operation and the day of the operation after the patient enters the operating room will be under multimedia with sedative content for 10 minutes and before The patient will leave the operating room to complete the questionnaires.)
Category
Prevention
3
Description
Control group: Control group: People in this group will receive routine training by a regular nurse the night before the operation and the day of the operation will be without intervention and the questionnaires will be completed before the patient leaves the operating room.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Roshanak Eftekhar Ardebili
Street address
Imam Khomeini Hospital.,Atai St.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3325 1401
Email
Emamhe@arums.ac.ir
Web page address
https://www.arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Street address
School of Nursing and Midwifery., between Hafez and Saadi Bridge intersections.,Highway shohada.
City
Ardabil
Province
Ardabil
Postal code
5615751147
Phone
+98 45 3372 6085
Email
fnm-ardabil@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Roshanak Eftekhar ardebili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 11.,Sanai Building 2.,Shahid Nosrat Ghorbani Alley.,Enghelab Street.,Aali Qapo Square
City
Ardabil
Province
Ardabil
Postal code
5615793813
Phone
+98 45 3371 9148
Fax
Email
r.eftekhar@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Roshanak Eftekhar Ardebili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 11.,Sanai Building 2.,Shahid Nosrat Ghorbani Alley.,Enghelab Street.,Aali Qapo Square
City
Ardabil
Province
Ardabil
Postal code
5615793813
Phone
+98 45 3371 9148
Email
r.eftekhar@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Roshanak Eftekhar Ardabili
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 11.,Sanai Building 2.,Shahid Nosrat Ghorbani Alley.,Enghelab Street.,Aali Qapo Square
City
Ardabil
Province
Ardabil
Postal code
5615793813
Phone
+98 45 3371 9148
Email
r.eftekhar@arums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Some data, such as information about the main outcome, can be shared after people are not identified.زمان
When the data will become available and for how long
The access period starts 1 year after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Can be requested for academic studies as well as for use in clinical treatment
From where data/document is obtainable
Applicants can apply for documentation by sending an e-mail to the main researcher of the study, Dr. Nasser Mozaffari, at naser.m51@gmail.com
What processes are involved for a request to access data/document
In order to receive the documents, a written letter must be sent from the place of application as well as the full details of the requesting person or university by email to the main researcher, and after review, it must be answered within 2-3 weeks.