| CTRI Number |
CTRI/2021/10/037027 [Registered on: 01/10/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
comparison of warm water foot emersion and tepid sponging on fever reduction . |
|
Scientific Title of Study
|
Clinical trial of warm water foot immersion v/s tepid sponging on reduction of fever |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anchal |
| Designation |
BSc nursing 4th yr student |
| Affiliation |
College of nursing GMCH 32 Chandigarh. |
| Address |
GMCH College of nursing
o block , Sarai Building
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9877468339 |
| Fax |
|
| Email |
anchaldhiman473@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti |
| Designation |
Prinicpal |
| Affiliation |
College of nursing GMCH 32 Chandigarh |
| Address |
CON GMCH
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646370541 |
| Fax |
|
| Email |
collegeofnursinggmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarushi |
| Designation |
BSc nursing 4th yr |
| Affiliation |
College of nursing GMCH 32 , Chandigarh |
| Address |
#1846 phase 5 SAS Nagar Mohali , near PTL Chowk
Rupnagar
PUNJAB
160059
India |
| Phone |
9877313856 |
| Fax |
|
| Email |
aarushimadaan383@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
College of Nursing |
| Address |
College of Nursing , O Block Sarai Building
GMCH Sector -32 Chandigarh
|
| Type of Sponsor |
Government medical college |
|
|
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 |
| Aarfaah |
GMCH |
College Of Nursing , O Block
Sarai Building Govt Medical College and Hospital Sector 32 A Chandigarh
Chandigarh
CHANDIGARH |
9646370541
zeearfa2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| gmch ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no intervention Control group |
control group |
| Comparator Agent |
tepid sponging |
tepid sponging with tap water for 15 min |
| Intervention |
Warm water foot immersion, |
Warm water foot immersion up to mid point of tibia in warm water with temperature 100 - 110 degree fahrenheit for 15 min . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients admitted in medicine wards of GMCH 32 Chandigarh.
2.Patient who are having fever more than 100oF will be given HWFI and tepid sponging. |
|
| ExclusionCriteria |
| Details |
Critically ill Patient(Intubated patients, unconscious patients, paralysed patients.
Mental retardation or subjects with mental illness.
Patients who are younger than 18 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of fever |
before intervention for base line .
then after 30 min of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body temperature will be reduce. |
Before intervention for base line .
then after 30 min of intervention. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/10/2021 |
| Date of Study Completion (India) |
29/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Study findings will be published after completion of the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Proposed study involves selection of study subjects in the medicine wards of GMCH 32 Chandigarh, based on inclusion criteria. If eligible, written informed consent will be obtained. Then a clinical trial of Warm Water Foot Immersion and tepid sponging was conducted for 15 mins. First experimental group of Warm water foot immersion involves immersion of foot up to midpoint of tibia in warm water .In second experimental group receiving the tepid sponging involve sponging of the body with tap water . Before and after the proposed trial recording of temperature was done. The Performa consist of two parts: PART-1: a) To collect socio-demographic data. b) Temperature recording sheet. PART-B: Self structured protocol on warm water foot immersion. Standardized procedure of tepid sponging
Data collected was analyzed with the help of descriptive and inferential statistics.
|