The purpose of this study is to compare the effect of face-to-face training and training based on augmented reality on the quality of spirometry test of patients with respiratory diseases.
Design
Quasi-experimental, double-blind, randomized study on 80 patients
Settings and conduct
After passing the training phase, patients enter the spirometry unit testing room to perform the test.
The form for assessing the duration of the test and the number of repetitions is completed by the nurse. Patient anxiety questionnaire is completed in both intervention and control groups by intern. After the procedure, the pulmonologist evaluates the interpretability of the test.
The educational content prepared for patient education includes brief explanations about respiratory diseases, introduction of spirometry test and the correct procedure for performing it, and common mistakes leading to errors in test results.
Participants/Inclusion and exclusion criteria
Among people with indications to evaluate pulmonary function tests, people with smartphones are included in this study.
Intervention groups
Patients are divided into two groups; the first group receives routine face-to-face training by the unit nurse. The second group watches augmented reality based education on their mobile phones.
Main outcome variables
duration of spirometry test; the frequency of repeating the spirometry test; Interpretability of spirometry test results; Anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220628055299N1
Registration date:2022-08-20, 1401/05/29
Registration timing:prospective
Last update:2022-08-20, 1401/05/29
Update count:0
Registration date
2022-08-20, 1401/05/29
Registrant information
Name
Ali Nouranian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
st-nouranian.a@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-09-01, 1401/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of Augmented Reality based patient training on acceptability of spirometry test in respiratory patients
Public title
Evaluating the effectiveness of Augmented Reality based patient training on acceptability of spirometry test in respiratory patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Indications for evaluating pulmonary function tests
Possessing a smartphone
Good mental health and absence of anxiety and depression disorders
Consent to participate in research and cooperation
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done individually. From the start date of sampling, all the people who visit the treatment center will be given a brief description of the plan and if they want to participate in the plan, they will receive a sealed envelope randomly selected from 80 envelopes. In 40 envelopes, the intervention group is written, and in the other 40 envelopes, the control group is written. Sampling continues until 80 people enter the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences,
Street address
University Headquarter, Kashani Blvd.
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SKUMS.REC.1400.174
Health conditions studied
1
Description of health condition studied
COPD
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
2
Description of health condition studied
ATHMA
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Quality of spirometry test
Timepoint
The effectiveness of patient education based on augmented reality on the quality of spirometry testing of respiratory patients after viewing the educational content and performing the test.
Method of measurement
Spirometry quality checklist based on duration, repetitions and interpretability of results
2
Description
Anxiety score
Timepoint
The effectiveness of patient education based on augmented reality on the anxiety score of respiratory patients at the beginning of the study (before the start of the intervention) and after performing the spirometry test.
Method of measurement
Spielberger overt and covert anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receives spirometry training at the time of referral for testing through augmented reality multimedia content. This content includes 4 sections: "The introduction of spirometry test and its applications, the necessary preparations before the test, the correct way to perform the procedure and how to use the respiratory spray" which can be watched on the client's mobile phone.
Category
N/A
2
Description
Control group: receives spirometry training at the time of referral for testing through face-to-face explanations. Necessary trainings for correct test and use of respiratory spray are provided orally by the nurse of the spirometry unit to the clients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Spirometry Unit of Shahr-e-kord Hajar educational and medical center
Full name of responsible person
Dr. Zahra Habibi
Street address
Parastar st.
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
000000000
Phone
+98 38 3222 5505
Email
habibi.z@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Esfandiar Heydarian
Street address
Research and Technology Vice-Chancellor, Shahrekord University of Medical Sciences, Kashani Blvd.
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
heidarian46@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Nouranian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hajar Hospital, Parastar Ave
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
000000000
Phone
+98 38 3222 5505
Fax
Email
st-nouranian.a@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Zahra Habibi
Position
Associate professo
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar st.
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
000000000
Phone
+98 38 3222 5505
Email
habibi.z@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Nouranian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hajar Hospital, Parastar Ave
City
Shahr-e-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
000000000
Phone
+98 38 3222 5505
Fax
Email
st-nouranian.a@skums.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 further information
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