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CTRI Number  CTRI/2026/04/109098 [Registered on: 22/04/2026] Trial Registered Prospectively
Last Modified On: 22/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study    
Study Design  Other 
Public Title of Study   To develop and validate composite comfort-pain-satisfaction scale(CCPS) 
Scientific Title of Study   To develop and validate composite comfort-pain-satisfaction scale(CCPS) 
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 Shikha Gupta 
Designation  Professor Anaesthesia  
Affiliation  Dayanand Medical College and Hospital  
Address  Department Of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines Ludhiana ,Punjab 141001

Ludhiana
PUNJAB
141001
India 
Phone  9814820622  
Fax    
Email  shikhadmc@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shruti Pandey  
Designation  PG Resident Anaesthesia  
Affiliation  Dayanand medical college and hospital  
Address  Department Of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines Ludhiana ,Punjab 141001

Ludhiana
PUNJAB
141001
India 
Phone  6232586167  
Fax    
Email  sp1231960@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shruti Pandey  
Designation  PG Resident Anaesthesia  
Affiliation  Dayanand medical college and hospital  
Address  Department Of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines Ludhiana ,Punjab 141001

Ludhiana
PUNJAB
141001
India 
Phone  6232586167  
Fax    
Email  sp1231960@gmail.com  
 
Source of Monetary or Material Support  
DAYANAND MEDICAL HOSPITAL 
 
Primary Sponsor  
Name  Dayanand medical college and hospital  
Address  Dayanand medical college and hospital, Tagore Nagar, Civil Lines,Ludhiana.141001, Punjab,India 
Type of Sponsor  Private medical college 
 
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 Shikha Gupta   Dayanand medical college and hospital   Department of Anaesthesia, Dayanand medical college and hospital, Tagore Nagar, Civil Lines Ludhiana, Punjab,141001
Ludhiana
PUNJAB 		 9814820622

shikhadmc@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical committee, dayanand medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adult patients aged 18 and above.
2.Scheduled for elective surgery under general anaesthesia.
3.Fully conscious, alert and oriented within one hour post extubation.
4.Able to comprehend simple instructions and provide self-assessed ratings.
5. Willing and able to provide written informed consent after explanation.
 
 
ExclusionCriteria 
Details  1.Emergency surgical procedures.
2.Post operative mechanical ventilation.
3.History of cognitive impairment, major psychiatric illness, or neurological deficits affecting comprehension.
4.Presence of significant language barriers or communication difficulties.
5.Documented hearing impairment.
6.Declines participation or withdraws consent at any point. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. validation of ccps scale
2. construct validity via correlation with NRS for pain
COMFORT-B for behavioural comfort
PSQ-18 for patient satisfaction 		 60 mins, 3 hrs, 6 hrs, 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. Feasibility of CCPS scale
2. Acceptability of the CCPS scale
3. Responsiveness to change 		 60 mins , 3hrs ,6 hrs ,24 hrs 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   04/05/2026 
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="10"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 22-07-2028 and end date provided 22-07-2038?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post operative assessment is a complex and multidimensional process involving physical, psychological and emotional components. Traditionally, postoperative assessment has emphasized pain intensity as the primary marker of recovery and quality of care. However pain does not fully capture the patients overall well being or satisfaction with the surgical and anesthetic experience. in recent years , the concept of patient-centered care has gained prominence in perioperative medicine, with increasing recognition of need for comprehensive assessment tools that integrate multiple facets of patients postoperative experience, including comfort and satisfaction. A prospective,observational, single-centre study will be performed intended to develop and validate a novel patient -reported outcome measure(PROM) , the CCPS scale.the duration of the study will be approximately 12 months, accounting the time required for preparatory work, pilot testing, recruitment of participants, serial data collection a predefined time intervals , interim analysis and final statistical evaluation. the timeline may be adjusted depending on the rate of recruitment and logistical consideration. approximately 120 sample size will be taken. the ccps scale will be used at 60min, 3hrs, 6hrs and 24hrs post extubation , and will be used in ASA1-3 patients, surgical procedure done under general anaesthesia between ages of 18-65. 
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