| CTRI Number |
CTRI/2020/06/025568 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
02/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
a study to evaluate the effectiveness of multicomponent program on prevention of delirium among critically ill patients admitted in selected ICUs of mullana Ambala Haryana |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of multicomponent program on prevention of delirium among critically ill patients admitted in ICU in selected hospital Mullana Ambala, Haryana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Thakur |
| Designation |
M.sc Nursing |
| Affiliation |
M.M.College of Nursing |
| Address |
Room No 325, Second Floor,Hostel NO 7, Maharishi Markandeshwar, University, Mullana-Ambala
Room No 325, Second Floor,Hostel NO 7, Maharishi Markandeshwar, University, Mullana-Ambala
Ambala
HARYANA
133207
India |
| Phone |
8571817148 |
| Fax |
|
| Email |
1thakurdiksha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
kanika Rai |
| Designation |
Professor |
| Affiliation |
M.M. University |
| Address |
M.M College of Nursing, Mullana, Ambala
M.M. College of Nursing, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
9872820564 |
| Fax |
|
| Email |
nehukanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diksha Thakur |
| Designation |
M.sc Nursing |
| Affiliation |
M .M. college of Nursing |
| Address |
Room NO 325, Second Floor, Hostel No 7, Mullana, Ambala
Room NO 325, Second Floor, Hostel No 7, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8571817148 |
| Fax |
|
| Email |
1thakurdiksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.M.College of Nursing, Mullana-Ambala |
|
|
Primary Sponsor
|
| Name |
Diksha |
| Address |
MM college of Nursing |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| kanika rai |
M M C O N |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Diksha |
M M Hospital |
second floor, Medical ICU
Ambala
HARYANA |
8571817148
1thakurdiksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Ethics Committee |
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, (2) ICD-10 Condition: F199||Other psychoactive substance use,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multicomponent Program |
It includes orientation regarding time, by providing Table clocks and calendars at bed side, Mobilisation by Active Passive exercises in morning for 10 minutes, Sensory stimulation by music therapy(Relaxing music) in morning for 20 minutes, Cognitive stimulation by puzzle game in the evening for 10-15 minutes , Sleep promotion by providing eye mask and ear plug whole night. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
77.00 Year(s) |
| Gender |
Both |
| Details |
more than 18 yeras of age
|
|
| ExclusionCriteria |
| Details |
MDAS more than 18 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| orientation regarding time date and surrounding, mobilization, sensory stimuklation, cognitive stimulation, sleep promotion by eye mask and ear plug related to prevention of delirium |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| prevention of delirium |
decrease the level of delirium |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
03/06/2020 |
| 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="11"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study to evaluate the effectiveness of Multicomponent program on prevention of delirium among critically ill patients admitted in ICU of Mullana Ambala Haryana. multicomponent program includes orientations to pateint by clock, calenders, and mobilization by active passive exercises, cognitive by puzzle games, sensory stimulus by music therapy , and sleep promotion by eye mask and ear plug. |