determination of the effect of interactive communication application on satisfaction and anxiety of intubated patients admitted to intensive care units
Design
Clinical trial, intervention and control group, randomized, single center, Sampling type: available eligibles, Segmentation: Random blocks with quadruple blocks
Settings and conduct
Place of study: Qom University of Medical Sciences and Health Services
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Desire for participating in the study
age 18-60 years old
Orientation to time, person and place
Reading, writing and seeing Ability
first experience of hospitalization in Intensive Care unit
24 hours after intubation
Exclusion criteria:
Hearing, tactile, visual disorders
Receiving sedatives, narcotics, benzodiazepines and barbiturates
Intervention groups
Intervention group: After obtaining informed consent and the completion of the Hamilton Anxiety Scale, eligible patients will enter the study immediately after admission in ICU. The desired application will be installed on nurse's mobile phone and the patient will interact via this application with the nurse when the need for communication arises.
Control group: After obtaining informed consent and the completion of the Hamilton Anxiety Scale, eligible patients will enter the study immediately after admission in ICU. In the control group the nurse communicates with patient via the routine routes.
Main outcome variables
Satisfaction with communication, Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111203008286N9
Registration date:2021-01-05, 1399/10/16
Registration timing:prospective
Last update:2021-01-05, 1399/10/16
Update count:0
Registration date
2021-01-05, 1399/10/16
Registrant information
Name
Fatemeh Bahramnezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fatemeh_bahramnezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of interactive communication application on satisfaction and anxiety of intubated patients admitted to intensive care units
Public title
The effect of interactive communication application on satisfaction and anxiety of intubated patients admitted to intensive care units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Desire for participating in the study
age 18-60 years old
Orientation to time, person and place
Reading, writing and seeing Ability
first experience of hospitalization in Intensive Care unit
24 hours after intubation
Exclusion criteria:
Hearing, tactile, visual disorders
Receiving sedatives, narcotics, benzodiazepines and barbiturates
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done from the Available samples. Randomized block with quadruple blocks will be used for division of participants. The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it.
Blinding (investigator's opinion)
Double blinded
Blinding description
The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it.
Placebo
Not used
Assignment
Parallel
Other design features
Designing an application by the researcher that can be installed on mobile phones to facilitate communication of intubated patients hospitalized in intensive care unit
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Nursing and Midwifery and School of Rehabilitation, Tehran University
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
-
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.TUMS.FNM.REC.1399.130
Health conditions studied
1
Description of health condition studied
communication of intubated patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Hamilton Anxiety Rating Scale(HARS)
Timepoint
Before starting the intervention and 4 days after intervention
Method of measurement
Hamilton Anxiety Rating Scale(HARS)
2
Description
Satisfaction score in Researcher-made questionnaire
Timepoint
Before starting the intervention and 4 days after intervention
Method of measurement
Researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Alert Intubated patients in intensive care unit that use the application designed by the researcher to communicate with nurses. The target population includes conscious intubated patients admitted to the intensive care units of hospitals affiliated to Qom University of Medical Sciences. The researcher refers to the intensive care units and enrolls patients with inclusion criteria. Sampling will be done from the Available samples. Randomized block with quadruple blocks will be used for division of participants. The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it. In the control and intervention group, after obtaining informed consent and completion of HARS questionnaire and researcher-made communication satisfaction questionnaire, eligible patients will be included in the study. In the control group, the nurse will communicate with the patient via the routine communication methods( According to an initial field study in intensive care units affiliated to Qom University of Medical Sciences , the only way to communicate is with the help of yes-no questions and lip-reading) and in the intervention group the desired application will be installed on the nurse's phone and the patient will communicate with the nurse via this application when then need arises. The nurse will use this application every time he/she communicates with the patient and he/she will be required to use this application for the communication during every shift. On fourth day of the study, the mentioned questionnaires will be completed again by the researcher by asking the questions of the questionnaire from the patient without additional explanation about the items. It will be coordinated with the head- nurse how the patients participated in groups will be divided for the nurse so that one nurse does not care for two patients at the same time in the intervention and control groups.
Category
N/A
2
Description
Control group: Alert Intubated patients in intensive care unit that use the routine methods of communication like yes/no question and lip reading, for communicating with nurses
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom University of Medical Sciences and Health Services, Shahid Lavasani St, Qom, Iran
Full name of responsible person
Mohadese Samimi
Street address
No 11, 4th Alley, 31th Alley, Kalhori St, Qom
City
Qom
Province
Ghoum
Postal code
۳۷۱۴۳۱۵۵۱۱
Phone
+98 25 3723 5849
Email
silvermoon8916@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
MOHAMMAD ALI SAHRAIAN
Street address
Deputy of research and technology, Sixth floor, Central organization of university, Corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohadese Samimi
Position
MS student of critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
silvermoon8916@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery School, East Nosrat st., Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
bahramnezhad.f@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery School, East Nosrat st, Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
fatemeh_bahramnezhad@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