| CTRI Number |
CTRI/2024/02/062870 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Thirst bundle to relieve thirst] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of thirst pack on reducing dryness of mouth in cancer patients under emergency treatment-a randomized clinical trail |
|
Scientific Title of Study
|
Effect of thirst-bundle on relieving thirst and dry mouth on cancer patients in intensive care unit patients (ICU)- a randomized clinical trial |
| Trial Acronym |
ICU |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayavaram NagaRani |
| Designation |
Post graduate |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of Public Health Dentistry
Room no : 10
Sibar institute of dental sciences
Takkellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8500047960 |
| Fax |
|
| Email |
nagarani.jayavaram@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPSrinivas |
| Designation |
Professor & Head of the department |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of Public Health Dentistry
Room no : 10
Sibar institute of dental sciences
Takkellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9849368466 |
| Fax |
|
| Email |
srinivaspachava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBSrilekha |
| Designation |
Assistant professor |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Department of Public Health Dentistry
Room no : 10
Sibar institute of dental sciences
Takkellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9703420999 |
| Fax |
|
| Email |
srilekhabhimana1417@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar institute of dental sciences,Takkellapadu,Guntur,Andhra pradesh |
|
|
Primary Sponsor
|
| Name |
DrLKrishna prasad |
| Address |
Sibar institute of dental sciences,Takkellapadu,Guntur,Andhra pradesh |
| 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 |
| J NagaRani |
Omega cancer hospital |
Department of surgical oncology
Grand trunk road
Guntur
Guntur
ANDHRA PRADESH |
8500047960
nagarani.jayavaram@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
No intervention provided |
| Intervention |
Thirst Bundle |
thirst bundle (Oral swab wipes, Sterile Ice cold water spray, Lip moisturizer) will be provided for 15minutes 8 times a day for 2 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients in ICU
Patients who are on Nothing By Mouth (NBM)
Patients who stays ≥24hrs in ICU
Patients whose TI or TD score of ≥ 3
Patients who provide consent form
Patients whose attenders provide assent form
|
|
| ExclusionCriteria |
| Details |
Patients having any oral cancers
Patients who are in critical condition
Patients who are not willing to participate
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Thirst Intensity |
At Baseline and after 2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thirst Distress score |
At Baseline and after 2 days |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/03/2024 |
| Date of Study Completion (India) |
23/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
subjects included were cancer patients under Intensive care unit from a oncology hospital of Guntur city, will be selected through purposive sampling. The subjects will be randomly categorized into two groups by a single investigator using block randomization. The groups are named as group A- Experimental group where thirst & group B-Control group, containing 21 in each group. subjects included in the study will be selected by using inclusion and exclusion criteria. In experimental group subjects will be provided with thirst bundle (Oral swab wipes, Sterile Ice cold water spray, Lip moisturizer) for 15minutes 8 times a day for 2 days and TI and TDS will be noted after each session. In control group no intervention will be provided. At the end of 2 days TI and TDS between control and experimental groups will be compared. The obtained will be analyzed using statistical test |