| CTRI Number |
CTRI/2022/11/047005 [Registered on: 03/11/2022] Trial Registered Prospectively |
| Last Modified On: |
02/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Caring touch and communication: a way to improve the care of critically ill patients |
|
Scientific Title of Study
|
A study to assess the effectiveness of caring touch and communication on delirium in critically ill adult patients: A randomized controlled, observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahalingam V |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences |
| Address |
College of Nursing,
AIIMS, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9719874259 |
| Fax |
|
| Email |
nurs_mahalingam@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahalingam V |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical sciences |
| Address |
College of Nursing,
AIIMS, Bhubaneswar
ORISSA
751019
India |
| Phone |
9719874259 |
| Fax |
|
| Email |
nurs_mahalingam@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Zeneeva Parvez |
| Designation |
M.Sc. Student |
| Affiliation |
All India Institute of Medical sciences |
| Address |
College of Nursing,
AIIMS, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7980712061 |
| Fax |
|
| Email |
zpmyhappyworld@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Mahalingam Venkatesh |
| Address |
AIIMS Bhubaneswar |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Mahalingam V |
ICU, AIIMS Bhubaneswar |
Department: Critical care areas
Division: CICU, Cardiology ICU, MICU,SHDU, Neurology ICU, Respiratory ICU
Room no.: Not applicable
AIIMS Bhubaneswar, Sijua, Patrapara, Dumduma, Bhubaneswar
Khordha
ORISSA |
9719874259
nurs_mahalingam@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAIIMSBhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caring touch and communication |
Non-verbal (touching, holding hands of the patient) cues used by family members for at least 30 minutes thrice each day along with talking about their day as they did normally avoiding stressors along with the routine care provided by nurses. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients and family members who consent to take part in the study
Patients with GCS >12
|
|
| ExclusionCriteria |
| Details |
Patients with severe neurologic injury
Patient expected to survive less than 48 hours
Patients with psychiatric and cognitive disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Delirium |
12 hour interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced length of stay in Hospital |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
07/11/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The investigator received IEC Approval and waiting administrative permission |