| CTRI Number |
CTRI/2018/02/011702 [Registered on: 05/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
03/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of ice gel pack on eye edema and bluishness among patients of craniotomy in Neurosurgery units, PGIMER Chandigarh, 2016-2018. |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of cryotherapy on peri-orbital edema and ecchymosis among patients of supra-tentorial craniotomy in Neurosurgery units, PGIMER Chandigarh, 2016-2018. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam kumari |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no. 118, MSc Nursing 2nd year, Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
175008
India |
| Phone |
7589077289 |
| Fax |
|
| Email |
kashyap.poonam123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi Agnihotri |
| Designation |
Clinical Instructor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
room no. 219, Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
smrishima@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi Agnihotri |
| Designation |
Clinical Instructor |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no.307, Nursing, National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
smrishima@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| 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 |
| Poonam kumari |
PGIMER, Chandigarh |
ward 3, Neurosurgery ICU, 3rd floor, Nehru Hospital, PGIMER Chandigarh, Pin code 160012
Chandigarh
CHANDIGARH |
7589077289
kashyap.poonam123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee (PGIMER, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post-operative 1st day, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
only routine care is given.No intervention was given |
| Intervention |
Experimental group |
It refers to the application of the ice gel pack for 10 minutes per 12 minutes every 3 hourly over peri-orbital area for four times/day from 8am to 5pm among patients of supra-tentorial craniotomy in Neurosurgical units, PGIMER Chandigarh in 2017.
Total 80 sample.
experiment group- 40 patient
control group- 40patients
COMPARATOR AGENT: Kara and Gokalan scale
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients of supra-tentorial craniotomy for non traumatic lesion with peri-orbital edema and ecchymosis |
|
| ExclusionCriteria |
| Details |
Periorbital edema due to other reasons like nephrotic syndrome, pregnancy, thyroid disorder, renal failure, cardiac failure, liver failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in periorbital edema and ecchymosis |
At the end of 4th post-operative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Beneficial for future craniotomy patients |
Beneficial for future craniotomy patients from June 2018 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2017 |
| Date of Study Completion (India) |
12/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
study is randomized control trial |