| CTRI Number |
CTRI/2018/05/013629 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
27/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Desciptive study |
| Study Design |
Other |
|
Public Title of Study
|
to check how much a patient will have pain, when they are severely ill |
|
Scientific Title of Study
|
A study to assess the pain level of the critically ill patients admitted in ICUs and the nurses’ perception on pain of critically ill patients in selected tertiary care hospital, Udupi district.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chhanda Chakraborty |
| Designation |
2nd Year M.Sc Nursing |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8787553595 |
| Fax |
|
| Email |
chhandachakraborty92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Daisy Josphine Lobo |
| Designation |
associate professor |
| Affiliation |
associate professor at Manipal College of Nursing, Manipal |
| Address |
Manipal College of Nursing
Manipal
Manipal College of Nursing, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535687697 |
| Fax |
|
| Email |
daisy.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elsa Sanatombi Devi |
| Designation |
Professor and HOD medical surgical department |
| Affiliation |
manipal college of nursing manipal |
| Address |
manipal college of nursing
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739864293 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
kasturba Hospital Manipal |
| Address |
Kasturba Hospital, Manipal |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chhanda Chakraborty |
Kasturba Hospital Manipal |
ICU 1, ICU 2, causality ICU , OF Kasturba hospital , ground floor, Manipal. medical department, unit 4 medical OPD room no 15
Udupi
KARNATAKA |
8787553595
chhandachakraborty92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Unconscious and or sedated ventilated patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient admitted in the Medical ICUs
Patients on invasive mechanical ventilation
Patients with GCS score of 8 and below
Ramsey Sedation Score of 4-6 |
|
| ExclusionCriteria |
| Details |
Patient’s with surgical wounds
patient with traumatic injuries
patients on NIV |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The purpose of the study is to assess the pain level of the critically ill patients and the
perception of the nurses regarding the pain of the critically ill patients. The findings of the study
will be useful to introduce pain control measures to develop and educate the nurses on pain
management in critically ill patients and reduce the level of pain experienced by the patients. |
February 20 to march 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/06/2018 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the study is to assess the pain level of the critically ill patient admitted in the ICUs and who are unable to communicate about their pain as because of they are unconscious or sedated and on ventilation as per the inclusion criteria for the study by using Behavioural Pain Scale and Physiological parameters and the nurses’ perception regarding the pain felt by the critically ill patients . |