Protocol summary

Study aim
Determining the effect of the use of patient communication software on the ease of communication and satisfaction with the quality of care of conscious patients under mechanical ventilation in ICU
Design
Semi-experimental intervention with a control group, with parallel groups, two-way blind, randomized, on 60 patients, spss software was used for randomization
Settings and conduct
After preparing the software and obtaining the consent of the patients hospitalized in the ICU, the selected statistical population is divided into two control and intervention groups by random allocation method. At first, the researcher is not aware of the allocation of people to two groups. The statistical analyst will also be unaware of the groups.
Participants/Inclusion and exclusion criteria
Patients hospitalized in special care departments of Mashhad public hospitals Inclusion: having an artificial airway, mastering the Persian language, an acceptable level of consciousness, minimum literacy, having the ability to see and hear, at least 24 hours of stay in the intensive care unit and attending the unit for a full day. Exclusion: history of mental problems, having an underlying disease affecting the level of consciousness, hospitalization of the patient due to head injuries, change in the patient's state of consciousness
Intervention groups
In the control group, communicating with the patient through common methods including lip-reading, sign language, etc., and in the intervention group, communicating with the use of designed software, each of the main needs of the patients is visualized on the pages. Digital has brought that these images themselves can be enlarged and sound, and by using it, it will be possible to communicate between the research nurse and the conscious patient without the ability to speak
Main outcome variables
Ease of communication, Satisfaction of conscious

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220315054293N1
Registration date: 2022-11-29, 1401/09/08
Registration timing: prospective

Last update: 2022-11-29, 1401/09/08
Update count: 0
Registration date
2022-11-29, 1401/09/08
Registrant information
Name
Zahra ُPoursadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3607 7453
Email address
z_psg@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using the Patient Communication software on the ease of communication andsatisfaction of conscious patients under mechanical ventilation admitted to the ICU
Public title
Application of patient communication software in conscious patients under mechanical ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having an artificial tracheal airway or tracheostomy Proficiency in Persian language Acceptable level of consciousness Minimum literacy Having the power of sight and hearing At least 24 hours of stay in the intensive care unit and one full day in the unit
Exclusion criteria:
Having a history of mental problems according to the patient's family Having an underlying disease affecting the level of consciousness Hospitalization of the patient due to head injuries Changing the patient's state of consciousness so that he is unable to communicate
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The selected statistical population is divided into two intervention and control groups by the randomization method with a random sequence generated through the Randomization site. After the random allocation, the allocations will be taken in the envelopes, and after selecting the research sample, it will be removed from the envelope in the allocation package, and the person will be placed in the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator and statistical analyst are unaware of the placement of the samples in the intervention or control group. In the data analysis stage, the groups will be entered into the software as A and B, and the statistical analyst will not be aware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Ibn Sina Street, doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.MUMS.REC.1401.074

Health conditions studied

1

Description of health condition studied
Conscious patients under mechanical ventilation
ICD-10 code
QF22
ICD-10 code description
Difficulty or need for assistance with communication

Primary outcomes

1

Description
Ease of communication
Timepoint
Before and after the intervention, 12 hours after the end of the intervention
Method of measurement
ECS Questionnaire

2

Description
Satisfaction with the quality of patient care
Timepoint
Before and after the intervention, 12 hours after the end of the intervention
Method of measurement
PSI questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, communication with the patient is through common methods to identify the needs of the patients. These methods are different according to the patient's condition and include lip reading, sign language, using pen and paper, and whiteboard, and the patient can express his feelings, needs and problems through them.
Category
N/A

2

Description
Intervention group: In this group, communication will be done using the software designed under the Android system. The communication software with the patient will have the facilities of playing audio, displaying schematic images, and the possibility of typing, and it has visual appeal, flexibility, beauty, and quality, so that, for example, each of the main needs of patients can be visualized in There are digital pages that can be enlarged and have audio. This software can be installed on the researcher's phone as a user of the software, and by using it, it will be possible to establish communication between the research nurse and the conscious patient without the ability to speak.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mahmoud Mohammadzadeh Shabestri
Street address
Imam Reza Hospital Square, Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
shabestarim@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Gholam Ali Mamouri
Street address
Ahmedabad St
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3840 0001
Email
MaamouriGh@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
Qurashi Building, next to Hoizeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@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
Zahra ُPoursadeghi
Position
Master's student in intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 6, Resalat St, 25th Ally,Faramarz Abbasi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3607 7453
Fax
Email
z_psg@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra ُPoursadeghi
Position
Master's student in intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 6, Resalat St, 25th Ally,Faramarz Abbasi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3607 7453
Fax
Email
z_psg@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra ُPoursadeghi
Position
Master's student in intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 6, Resalat St, 25th Ally,Faramarz Abbasi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3607 7453
Fax
Email
z_psg@yahoo.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
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