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CTRI Number  CTRI/2024/04/065491 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Experience of Patients and relatives in Critical Care Unit 
Scientific Title of Study   Humanism in the ICU Mixed method study of experience of care by patients, relatives and health care professionals  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gunchan Paul 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Critical Care Medicine Fourth Floor, Room No. 10 ICU block Dayanand Medical College and Hospital Civil Lines Tagore Nagar, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9878645330  
Fax    
Email  gunchan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gunchan Paul 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Critical Care Medicine Fourth Floor, Room No 10 ICU bLOCK Dayanand Medical College and Hospital Civil Lines Tagore Nagar, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9878645330  
Fax    
Email  gunchan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gunchan Paul 
Designation  Professor 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Critical Care Medicine Fourth Floor, Room No. 10 ICU Block Civil Lines Tagore Nagar, Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  9878645330  
Fax    
Email  gunchan@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana 
 
Primary Sponsor  
Name  NIL 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Gunchan Paul  Dayanand Medical College and Hospital, Ludhiana  Department of Critical Care Medicine Fourth Floor Room no 10 ICU Block Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana.141001
Ludhiana
PUNJAB 
09878645330

gunchan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  experience of ICU stay 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria -patients who had stayed in an ICU more than 96 hours, their family members and HCW, aged 18 years or more
Family members will be defined as any of the relatives involved in care of the patient (survivors & nonsurvivors)
HCW- The doctors and nurses dedicated to the care of critically ill patients in ICU
 
 
ExclusionCriteria 
Details  age <18years
ICU stay <96 hours 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary objective: To understand how patients and family members experience humanizing or dehumanizing treatment when admitted in the ICU.
 
96 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Objective:
1) Factors leading to dehumanizing behavior experienced during the ICU care
2) Outcomes of dehumanizing behavior experienced during the ICU care 
96 hours 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   21/04/2024 
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="0"
Months="1"
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  

Objectives: To explore the perception of stakeholders (patients, family members and health care workers) about humanistic care in the intensive care unit.

Primary objective: To understand how patients and family members experience humanizing or dehumanizing treatment when admitted in the ICU.

Secondary Objective:

1) Factors leading to dehumanizing behavior experienced during the ICU care

2) Outcomes of dehumanizing behavior experienced during the ICU care

Methodology

1. Context and Location:

The study will be performed in the ICUs of a tertiary care hospital in north India. The ICUs practice open visitation policy for the visitors and allow active participation of the family in patient care.

2. Study design

The study will be carried out using mixed methodology (qualitative and quantitative).

3. Data Collection:

3a. Qualitative investigation: This will be based on inductive grounded theory approach.

Keeping our focus on the patient’s, family member’s, doctor’s and nurse’s perception on humanizing or dehumanizing during communication, routine care and procedures, we will be conducting in-depth interviews of all the stakeholders. Grounded theory approach involves moving back and forth between data collection and analysis until a theory that fits the data emerges. (8)

The participants will be selected by theoretical sampling that is the individuals likely to provide the needed information will be included and will also include people with different sex, age, varying clinical and socio-demographic characteristics. The data obtained from the first participants will determine which new participants need to be included until the saturation of the data. Hence, the sample size will be governed by the spectrum of data needed to develop a theory, so it cannot be determined before the data collection starts. (9)

Family members will be defined as any of the relatives and friends visiting the patient. Several family members will be included for the same patient as experience may vary depending on the relationship with the patient. For each family member, age, gender, educational status and relationship with the patient will be recorded. The only inclusion criteria will be that patients had stayed in an ICU more than one week , and these patients, their families and HCW are aged 18 years or more.

The doctors and nurses with dedicated to the care of critically ill patients in ICU will be interviewed. After taking an informed consent, the main investigator will invite the participants for the interview, which will be conducted in the vernacular language. It will be audio recorded and field notes will be taken during the interview. (11) We plan to ask questions in all forms: hypothetical, ideal, interpretative or leading.

3b. Quantitative investigation: A structured proforma will be distributed to the stakeholders by the main investigators. Items of the performa will be rated on Likert Scale.

4. Analysis:

4a. Qualitative analysis: The methods will follow recommendations for qualitative analysis by Ritchie et al. (12) The methods and procedures of grounded theory will involve cycles of data collection and analysis to identify interrelations among concepts, which eventually will be aggregated into an integrative theory.

The data collected in the form of audio recordings will undergo verbatim transcription and translation, and together with the field notes, explanations will be developed, patterns detected, typologies established and categories identified. (12)

4b. Quantitative analysis of structured data: Responses to items will be coded as categorical variables and their association with the main explanatory variable will be seen.

Statistics

5a. Qualitative Statistical Analysis: After summarization the data, a thematic framework will be built. This will include identifying initial themes or concepts, constructing a conceptual framework, labeling the data followed by sorting and synthesising the data. This will be followed by descriptive and associative analysis to develop an explanation. (12)

5b. Quantitative Statistical Analysis:

Responses will initially be probed using univariate analysis by using the chi-square test. Subsequently, multivariate analysis for those which have p value > 0.1 will be undertaken.

6. Ethics

Before submitting the study we will seek approval of the Institutional Ethical Committee. Written informed consent in vernacular language will be taken from the respondents. Privacy of participation and confidentiality of the data will be maintained by coding the transcripts using numbers and not including any participant identifiers on the transcripts.

 
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