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CTRI Number  CTRI/2024/11/076473 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Ice Chips of sterile water]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on the effect of ice chips compared to routine care on thirst and dry mouth in postoperative patients at hospital in Bhubaneswar 
Scientific Title of Study   A comparative Study to assess the effectiveness of an ice chips versus routine care on thirst intensity and dryness of mouth among postoperative patient at tertiary care hospital Bhubaneswar 
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. Mahalingam Venkateshan 
Designation  Assistant Professor(Critical Care) 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE,BHUBANESWAR 
Address  AIIMS Bhubaneswar, Sijua, Patrapada. Department: Critical Care, Room No:03, 1st floor, College of Nursing AIIMS BBSR.ORISSA, 751019, INDIA
AIIMS Residential complex college of Nursing AIIMS BBSR Pin code: 751019
Khordha
ORISSA
751019
India 
Phone  9719874259  
Fax    
Email  nurs_mahalingam@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mahalingam venkateshan 
Designation  Assistant Professor (Critical care) 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE,BHUBANESWAR 
Address  College of Nursing Department: Critical Care, Room No: 03, 1st floor, AIIMS Bhubaneswar, Sijua, Patrapada, 751019

Khordha
ORISSA
751019
India 
Phone  9719874259  
Fax    
Email  nurs_mahalingam@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr. Mahalingam venkateshan 
Designation  Assistant Professor (Critical care) 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE,BHUBANESWAR 
Address  College of Nursing, Room No:03, 1st Floor, Department: Critical Care, AIIMS Bhubaneswar, Sijua, Patrapada, ORISSA, 751019 INDIA
College of Nursing, Room No:03, 1st Floor, Department: Critical Care, AIIMS Bhubaneswar, Sijua, Patrapada, ORISSA, 751019 INDIA
Khordha
ORISSA
751019
India 
Phone  9719874259  
Fax    
Email  nurs_mahalingam@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
Gastro Surgery intensive care unit of AIIMS BHUBANESWAR.PIN Code: 751019 ORISSA, INDIA 
 
Primary Sponsor  
Name  AIIMS BHUBANESWAR 
Address  COLLEGE OF NURSING AIIMS BHUBANESWAR, Sijua, Patrapada, 751019, ORISSA, INDIA 
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 Mahalingam Venkateshan  AIIMS Bhubaneswar   Gastro surgery ICU Department fourth floor, surgery ward 2nd floor, Sijua, Patrapada, Bhubaneswar, ORISSA,PIN-CODE:751019
Khordha
ORISSA 		 9719874259

nurs_mahalingam@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS BBSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ice chips of sterile water  Details of intervention: The postoperative patient admitted in ICU will feel thirsty and have dry mouth during postoperative period. By using Numeric rating scale, the patient will be asked to rate his or her thirst level varying from thirst level 0 to 10. (0 indicate to no thirst and 10 indicate severe thirst) and dry mouth assessed by oral assessment guide. If the numerical rating scale more than 4 and oral assessment guide more than and equal to 9 then using the oral assessment guide (based on safety protocol for thirst management) safety level for administration of intervention that is, to provide Ice chips will be assessed. Experiment group will receive ice chips in Immediate postoperative period (based on “Safety protocol for management of thirst”) and control group will receive the routine care (oral care). In intervention (ice chips), 2 ml of sterile water for each ice cube, form ice cube, frozen, uniform-sized pieces, which have to place in the patient’s mouth to till completely dissolve. Experiment group will assess for 2 hour, every 30 minutes (4 times ice chips for one patient).Then, after 2 hour evaluation of thirst intensity and dryness of mouth.), Thirst intensity assess initially and end of the intervention; intervention perform according to the experimental group 2 mL ice chips and control group, routine care. During intervention of ice chips, patients should be alert and able to sit upright (follow the “Safety protocol for management of thirst”).  
Comparator Agent  Routine oral care   Routine oral care performed at regular interval as per the hospital protocol preventing complication and promoting over all oral health in individual who have undergone surgical procedure. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult, male or female with an age greater than 20 years.
Post-operative patient undergone surgery.
Willing to participate in the study.
conscious alert: Talks, verbalizes thirst, has consistent answers and is oriented.
coughs with verbal command; breaths in and uses the thoracic and abdominal muscles, expelling high air flow.
Swallows voluntarily or with verbal command
No nausea complaints.
No Vomiting.
 
 
ExclusionCriteria 
Details  Drowsy: Wakes Up after verbal Command, makes eye contact and has understandable verbal response, going back to sleep after the end of stimulus.
Does not cough with verbal command.
Does not swallow with verbal Command.
Complains of nausea.
Complain of vomiting. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of ice chips on thirst intensity & dryness of mouth.
 		 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effectiveness of an ice chips with routine care on thirst intensity & dryness of mouth
 		 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   11/11/2024 
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="3"
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 aims to compare the effectiveness of ice chips versus routine care in reducing thirst intensity and dryness of mouth among postoperative patients at AIIMS Bhubaneswar. The research will address two main questions: whether ice chips significantly reduce thirst compared to routine care and whether they alleviate dry mouth. The objectives include assessing the effectiveness of ice chips on both thirst intensity and dryness and comparing their impact against standard care.

The study will employ a quantitative, true experimental design with purposive sampling, targeting postoperative patients in the ICU. Inclusion criteria will consist of adults over 20 years who have undergone surgery and are alert and able to communicate. Exclusion criteria will rule out patients who are drowsy, unable to swallow, or experiencing nausea or vomiting.

The intervention protocol involves using ice chips made from sterile water, administered to patients who rate their thirst as 4 or higher on a numerical scale and have a dry mouth score of 8 or higher. Patients in the experimental group will receive these ice chips every 30 minutes for two hours, while the control group will receive standard oral care. Ethical considerations will ensure patient autonomy and confidentiality throughout the study. Overall, this research seeks to provide evidence-based insights into managing postoperative thirst and dry mouth, enhancing patient comfort during recovery.

 
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