CTRI Number |
CTRI/2023/09/057626 [Registered on: 14/09/2023] Trial Registered Prospectively |
Last Modified On: |
12/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Process of Care Changes |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Effect of cold water and lip balm on thirst and dry mouth in patients admitted in critical care unit: A randomized control trial |
Scientific Title of Study
|
Effectiveness of cold water spray and application of lip moisturizer on level of thirst and dry mouth among the patients admitted in the Critical Care Unit: A randomized control trial |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr M J Kumari |
Designation |
Professor cum Principal (Ag) |
Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research |
Address |
Department of Medical Surgical Nursing,College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006.
Pondicherry PONDICHERRY 605006 India |
Phone |
9894595420 |
Fax |
|
Email |
kumari_mj@ymail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr M J Kumari |
Designation |
Professor cum Principal (Acting) |
Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research |
Address |
Department of Medical Surgical Nursing,College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006.
Pondicherry PONDICHERRY 605006 India |
Phone |
9894595420 |
Fax |
|
Email |
kumari_mj@ymail.com |
|
Details of Contact Person Public Query
|
Name |
Grace Moanaro Imchen |
Designation |
M.Sc Medical Surgical Nursing student |
Affiliation |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research |
Address |
College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry PONDICHERRY 605006 India |
Phone |
9402857433 |
Fax |
|
Email |
moanaimchen19@gmail.com |
|
Source of Monetary or Material Support
|
Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006. |
|
Primary Sponsor
|
Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Address |
Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006. |
Type of Sponsor |
Research institution and hospital |
|
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 |
Dr M J Kumari |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Crtical care unit 1st floor institute block and Surgical oncology intensive care unit 1st floor Super Speciality block
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006. Pondicherry PONDICHERRY |
9894595420
kumari_mj@ymail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee for Human studies, Jawaharlal Institute of Postgraduate Medical Education and Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R638||Other symptoms and signs concerning food and fluid intake, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Cold sterile water spray and lip moisturizer |
Patients in the intervention group will get cold sterile water (4Ëš C) spray every hour and application of lip moisturizer every second hourly from 8 am to 4pm for 3 days along with routine care of mouthwash at 2 pm |
Comparator Agent |
Cold sterile water spray and lip moisturizer on request |
Patients in the control group will be provided with cold sterile (4Ëš C) water spray, application of lip moisturizer when requested by patient, along with routine care of
mouthwash at 2 pm
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
Above 18 yrs of age
ICU stay of >12 hrs
Richmond agitation sedation score of -1,0 or +1
Those patients who are well oriented to date, time and place
Thirst score of ≥ 1 on a numeric rating scale
|
|
ExclusionCriteria |
Details |
Patients who were unable to communicate and not oriented
Patients who underwent recent oral surgery
Patients who has open lesion in mouth or lips
Patients with OPC poisoning
Intubated patients
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess the effect of cold water spray and application of lip moisturizer on the level of thirst and dry mouth among patients admitted in CCU. |
8am to 4pm for 3 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
No secondary objective |
No time points |
|
Target Sample Size
|
Total Sample Size="108" Sample Size from India="108"
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)
|
22/09/2023 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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 is a randomized control trial to assess the effectiveness of cold water spray and application of lip moisturizer on the level of thirst and dry mouth among patients admitted in the critical care unit. Patients who met the inclusion criteria will be enrolled from the critical care units by consecutive sampling method. informed consent will be obtained and the procedure will be performed from 8am to 4pm for three days. Initial data for every
participant will be collected before the beginning of procedure: demographic data, admitting diagnosis, APACHE II
score, lab values for serum potassium, sodium, blood glucose, BUN, creatinine as well
as net balance and use of diuretics. Assessment of thirst and dry
mouth will be done every day for three days before the procedure and within
1 hour after the procedure. Post test assessment will be
done by a person who is not a part of the research team to avoid researcher’s bias and for post test reliability. Thirst will be assessed using a
numerical rating scale (0- 10, where 0= no thirst and 10= worst possible
thirst) and dry mouth
will be assessed using
The Challacombe Scale of Oral Dryness. |