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CTRI Number  CTRI/2025/10/096561 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes
Other (Specify) [Supportive Care]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see whether using the communication board helps ICU patients on ventilators communicate better and feel less anxious. 
Scientific Title of Study   Effect of augmented communication board on ease of communication, perceived anxiety and satisfaction in mechanically ventilated conscious patients admitted in Intensive Care Unit.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms Shrayanti Sahana 
Designation  M.Sc. Nursing Student 
Affiliation  College of Nursing ,AIIMS Bhubaneswar 
Address  College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada ,Khordha,PO-Dumuduma, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9007438347  
Fax    
Email  sshrayanti@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr L Anand 
Designation  Associate Proffesor 
Affiliation  College of Nursing ,AIIMS Bhubaneswar 
Address  College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada ,Khordha,PO-Dumuduma, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9612681996  
Fax    
Email  con_anand@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr L Anand 
Designation  Associate Proffesor 
Affiliation  College of Nursing ,AIIMS Bhubaneswar 
Address  College of Nursing, AIIMS Bhubaneswar, Sijua, Patrapada ,Khordha,PO-Dumuduma, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9612681996  
Fax    
Email  con_anand@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences , Bhubaneswar 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr L Anand  AIIMS BHUBANESWAR  Central ICU (floor-2),Medical ICU,(floor-2)Neurology ICU,Neurosurgery ICU,(floor-4)Surgical ICU(floor-2),Gastro ICU(floor-4), Respiratory ICU(floor-3), All India Institute of Medical Sciences (AIIMS), Sijua, Patrapada, Bhubaneswar, Odisha, 751019
Khordha
ORISSA 		 9612681996

con_anand@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,AIIMS Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I21||Acute myocardial infarction, (2) ICD-10 Condition: I130||Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease, (3) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, (4) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine care  The control group include patients receiving primary communication methods such as mouthing words, gesture, and writing. 
Intervention  USE OF AUGMENTED COMMUNICATION BOARD  Demonstration of augmented communication board by self on allocation. It involves basic needs of the patient such as hunger, toilet, pain. Nurse investigator assists the patient to use augmented board during each interaction. On the same day onwards, the augmented communication board will be administered to the patient by the investigator. It includes supervision of use of augmented communication board and assisting the patient to communicate using the board for communicating basic needs. 1.The intervention will be provided for 7 days or till the patient is admitted in the ICU, whichever is earlier. 2.The group will receive augmented based board during each interaction. 3.On the 7th day or till the patient is admitted in the ICU, the ease of communication and perceived anxiety will be assessed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Conscious and Oriented patient in ICU
GCS more than equals to 13
Patient with TT,ET or BiPAP, CPAP undergoing mechanical ventilation
Age more than 18 years to 90 years
Intubated for more than 24 hrs.
RAAS Score - -2,0,+2
 
 
ExclusionCriteria 
Details  Visual impairments that interfere with color interpretation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Ease of communication  7 days or till the patient is admitted in the ICU 
 
Secondary Outcome  
Outcome  TimePoints 
perceived anxiety  at the time of discharge or at 7 days whichever comes earlier 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Conscious patients on mechanical ventilation in the Intensive Care Unit (ICU) often face difficulty in expressing their needs and feelings, which can lead to frustration and anxiety. Augmented communication boards use pictures and symbols to help these patients communicate more easily with healthcare providers. This study aims to assess whether using such communication boards improves ease of communication and reduces anxiety among mechanically ventilated conscious ICU patients who are cognitively able to use the board.

 
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