Investigating the Effect of Rehabilitation Teaching by Augmentation Reality Pamphlet Method on the Quality of Life in Patients with Face and Neck Burn
Design
A randomized controlled trial with control group, parallel, without blinding, using random sequences generated by random number table
Settings and conduct
This study was performed in the burn ward of Imam Reza Hospital in Mashhad. Patients in the intervention group will use augmented reality pamphlet for one and a half months. In the control group, they will receive simple pamphlets and routine staff training. Then the questionnaire (BSHS-FN) will be completed in both groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient 18-65 years old has deep or superficial grade 2 burns to face and neck, overall burns up to 5% to 25%, mobile phone with Android OS. Exclusion criteria: Has hearing or visual impairment, history of diabetes mellitus, skin allergy, MS disease, malignancy, deformity and movement disorders in the face and neck, mental disorders, use of psychotropic drugs from 6 months or drug use.
Intervention groups
Patients in the intervention group will use augmented reality pamphlet for one and a half months (2 days in hospital and one month at home). Patients will receive control, simple pamphlets and routine training by staff.
Main outcome variables
Quality of Life in Patients with Face and Neck Burn
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191017045143N1
Registration date:2020-08-21, 1399/05/31
Registration timing:registered_while_recruiting
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Masoumeh Zal
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 7455
Email address
zalm2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Rehabilitation Teaching by Augmentation Reality Pamphlet Method on the Quality of Life in Patients with Face and Neck Burn
Public title
Investigating the Effect of Rehabilitation Teaching by Augmentation Reality Pamphlet Method on the Quality of Life in Patients with Face and Neck Burn
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should be alert
The patient may have burns to the face and neck
The patient has grade 2 or superficial burns
The patient had a burn rate of 5 to 25 percent
Patient will have access to mobile phone with Android OS
The patient is literate to use software guidelines
The patient has the ability to use their hands to use mobile phones and software
The patient should have a telephone number to call the researcher
The patient will be able to go to Imam Reza Hospital for a dressing change or re-visit after one month of discharge
The patient has full consent to participate in the study
The patient is between 18 and 65 years of age
The patient should be resident in Mashhad
Exclusion criteria:
The patient may not be able to visit the hospital for a doctor's appointment or change of dressing
Having auditory or visual problems
history of diabetes mellitus, skin allergy, MS disease, malignancy, deformity and motor disorders in the face & neck, mental disorders
psychoactive drugs consumption since 6 months ago and positive history of drug abuse
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: From simple randomization model, each client is placed in intervention or control group.
Randomization Unit: Individual
Randomization Tool: Random Number Table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The pamphlet design is augmented with the fact that the content of the software will be based on the latest educational guides and the collaboration of other medical team specialists in the field of face / neck sports (each area has 12 exercise movements). There will be educational images and pictures
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreyshi building.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.074
Health conditions studied
1
Description of health condition studied
Face and Neck Burn
ICD-10 code
T20.20XA
ICD-10 code description
Burn of second degree of head, face, and neck, unspecified site
Primary outcomes
1
Description
The quality of life in patients with face and neck burn
Timepoint
Evaluation of the quality of life of patients with face and neck burn before , 1 month and half months after intervention.
Method of measurement
Burn Specific Health Scale. Face & Neck) BSHS-FN questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 48 hours after the acute phase of burn, this pamphlet and its mobile application will be installed and run on the patient's mobile phone to familiarize the patient with the software during hospitalization. Use of the software will continue for 15 days during hospitalization and one month after discharge.
Category
Rehabilitation
2
Description
Control group: Patients in the control group will receive routine education, by the researcher, 48 hours after the acute phase.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for burns of Imam Reza Hospital
Full name of responsible person
Razieh Froutan
Street address
Imam Reza Hospital Square, Imam Reza Hospital
City
Mashhsd
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
froutanr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, Mashhad University of Medical Sciences, Deputy of Research
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery. Ebn-e-sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery. Ebn-e-sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoumeh Zal
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery. Ebn-e-sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3621 7455
Email
Zalm2@mums.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