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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
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