Protocol summary

Study aim
Determining the effect of communication board on physiological parameters and perceived quality of nursing care in patients with artificial airway.
Design
A randomized study with control group, parallel groups, without blinding, without placebo, randomization with blocking method with 60 samples
Settings and conduct
The research environment will be critical care units. Firstly, a demographic questionnaire will be completed. Blood samples were then collected between 7 and 8 am in both groups to assess cortisol levels. Vital signs will also be recorded in both groups. In the intervention group, the communication board is provided in the morning shift. In the control group, the nurse-patient communication method will be routine, by the nurse, and the patient will answer non-verbally. A second blood sample will be collected from both groups at 10:30 am to 11:30 am and vital signs of both groups will be recorded. Then nursing care quality questionnaire will be completed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 60, having artificial airway, full consciousness and no use of sedative drugs, minimum literacy, speaking and understanding Persia, no hearing or sight or cognitive problems, no history of having artificial airway, no use of drugs effecting cortisol level, no disease and medications that affect hemodynamic parameters. exclusion criteria: psychotic and depressive disorder, definitive or probable diagnosis of brain injury, and no Willingness to participate in research.
Intervention groups
In the intervention group, the communication board is given to the patient in the morning shift to communicate. In the control group, the nurse-patient communication method will be routine, like nurse’s frequent questions and patient’s non-verbally responses
Main outcome variables
Serum cortisol level, vital signs, quality of nursing care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190914044768N1
Registration date: 2019-10-31, 1398/08/09
Registration timing: registered_while_recruiting

Last update: 2019-10-31, 1398/08/09
Update count: 0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
anahita divani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6617 9056
Email address
adivani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-21, 1398/07/29
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using communication board on physiological parameters and perceived quality of care in patients with artificial airways
Public title
The effect of communication board on physiological parameters and quality of nursing care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years old having oral/nasal endotracheal tube or tracheostomy Complete consciousness (GCS = 9 + T, 10+T and four score = 13) not receiving sedative medications Minimum literacy Speech and understanding of Persian language Lack of hearing, visual or cognitive impairment No previous intubation or previous tracheostomy Not taking medications that affect cortisol level No disease affecting hemodynamic parameters. Not taking medications that affect hemodynamic parameters
Exclusion criteria:
The definitive or probable diagnosis of brain injury Unwillingness to participate in research Psychotic diseases and depression
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Because there is no list of patients, there is no information contamination. Therefore, the blocking method is used for randomization. Thus, letter A is considered as intervention group and letter B is considered as control group. Then write all the permutations of the letters A, A, B and B, which are 6 different combinations on the 6 cards: 1. AABB, 2. ABBA, 3. ABAB, 4. BAAB, 5. BABA, 6. BBAA, We then randomly select between 1 and 2 digits (using the random number table or asking patient number one to select a card randomly). For example, if the digit 1 is selected, it means that the first patient will be in the intervention group, the next two patients will be in the control group and the fourth patient will be in the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Nursing and Midwifery and Rehabilitation, Tehran Universi
Street address
School of Nursing and Midwifery,Tehran University of Medical Sciences, Mirkhani sreet, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-09-07, 1398/06/16
Ethics committee reference number
IR.TUMS.FNM.REC.1398.108

Health conditions studied

1

Description of health condition studied
using artificial airway
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
serum cortisol level
Timepoint
firstly, 7 to 8 am before intervention, after intervention 10:30 to 11:30 am
Method of measurement
3 ml blood sample through peripheral veins

2

Description
vital signs
Timepoint
firstly before intervention 7 am, then after intervention 1 pm
Method of measurement
Vital Signs Monitoring Device

3

Description
perceived quality of nursing care in communication dimension
Timepoint
firstly before intervention 7 am, then after intervention 1 pm
Method of measurement
quality of nursing care questionnaire (QUALPAC)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, at the beginning of the intervention, the cause and manner of using the communication board will be stated for the patient. The board consists of two sides, one side consisting of alphabet and a place for writing, and other side consisting of simple pictures of possible and common patients' needs with subtitle phrases. The communication board is provided to the patient during the morning shift (7 am-1 pm) to communicate with the nurse.
Category
Behavior

2

Description
Control group: In the control group no additional action will be taken. The nurse-patient communication will continue in routine method, like nurse’s frequent questions and patient’s non-verbally responses and by body movements.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Anahita Divani
Street address
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Email
imamhospital@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeeian
Street address
Tohid Square, Dr. Mirkhani St. (East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
fnm@tums.ac.ir
Web page address
http://fnm.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
Anahita Divani
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Email
adivani@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Divani
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Fax
Email
adivani@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Divani
Position
masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Email
adivani@razi.tums.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
Patient privacy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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