| CTRI Number |
CTRI/2025/05/087665 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
25/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cold saline and room temperature saline] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of oral care with cold and room temperature saline among cancer patients |
|
Scientific Title of Study
|
Effect of oral care with Ice-Cold versus Room-Temperature Saline on thirst and oral discomfort among patients undergoing various cancer treatments in a selected tertiary hospital, Mangaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jubal Naome Fernandes |
| Designation |
Postgraduate student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Medical-Surgical Nursing
4th Floor
Father Muller College of Nursing Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7083204375 |
| Fax |
|
| Email |
jubalnaomefernandes40945@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MS Denitha T |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Medical- Surgical Nursing
4th Floor
Father Muller College of Nursing
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7975123394 |
| Fax |
|
| Email |
denithatj@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
MS Denitha T |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Medical -Surgical Nursing
4th Floor
Father Muller College of Nursing
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7975123394 |
| Fax |
|
| Email |
denithatj@fathermuller.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jubal Naome Fernandes |
| Address |
Father Muller College of Nursing
Kankanady
Mangaluru Karnataka India 575002 |
| 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 |
| Ms Denitha T |
Father Muller Hospital Oncology wards |
Medical- Surgical Nursing
4th Floor
Father Muller Charitable Institutions Kankanady Mangaluru
Dakshina Kannada
KARNATAKA |
7975123394
denithatj@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ice cold saline and room temperature saline |
Check the temperature of the ice-cold and room-temperature saline using lotion thermometer.
Prepare necessary equipment (e.g. cups, tissues, or towels for patient comfort).
Explain the purpose of the mouthwash and the procedure to the patient.
Inform the patient about the expected benefits, such as reducing oral discomfort and thirst.
To avoid choking, help patients who are partially dependent into a comfortable sitting position with their head slightly forward. After swishing and gargling, the patient should spit out the mouthwash into a basin/bowl or sink.
For patients who can walk independently, instruct them to go to the sink, take a small amount of the mouthwash solution, tilt their head slightly forward, gargle gently, and then spit the solution into the sink.
Pour the prescribed amount of mouthwash into a clean cup (usually 50ml).
Instruct them to take a small sip of mouthwash and hold it in their mouth.
Instruct the patient to gently swish the mouthwash around their mouth, making sure to cover all surfaces, including the teeth, gums, and the roof of the mouth.
Ask the patient to gargle for a one minute, ensuring the mouthwash reaches the back of the throat. Instruct them to take smaller sips of the saline solution, holding each sip in their mouth for a few seconds before spitting it out.
After swishing and gargling, the patient should spit out the mouthwash into a basin/bowl or sink.
Pretest score will be assessed before the intervention and the posttest will be assessed after the intervention 4 times a day for 5 consecutive days.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cancer:
1. Who are above 18 years of age.
2. Receiving chemo and radiation treatment with thirst and oral mucositis.
3. Who can communicate and rate their level of thirst and oral discomfort.
|
|
| ExclusionCriteria |
| Details |
Patients with cancer:
1. Who are critically ill.
2. Who are not able to tolerate saline and may have allergies or adverse side effects.
3. Who have dental issues with sensitivity to cold in the mouth.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients will get relief from thirst and oral discomfort |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intervention can improve oral hygiene |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study helps to give relief to cancer patients with thirst and oral discomfort undergoing various cancer treatments. |