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CTRI Number  CTRI/2024/04/066243 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Pain scoring in cancer patients 
Scientific Title of Study   Assessment of Pain in Cancer Patients Undergoing Chemotherapy by Using McGill Pain Questionnaire 
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 Maitri Patel 
Designation  Senior Rsident 
Affiliation  Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha 
Address  Anaesthesia department , Jawaharlal Nehru Medical college ,Sawangi(Meghe),Wardha MAHARASHTRA India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9033004558  
Fax    
Email  patelmaitrii26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek Chakole 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Anaesthesia department , Jawaharlal Nehru Medical college ,Sawangi(Meghe),Wardha MAHARASHTRA India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  7583836564  
Fax    
Email  drvivekchakole@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Maitri Patel 
Designation  Senior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Anaesthesia department , Jawaharlal Nehru Medical college ,Sawangi(Meghe),Wardha MAHARASHTRA India 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9033004558  
Fax    
Email  patelmaitrii26@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Datta Meghe Institute of higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College 
Address  Anaesthesia department , Jawaharlal Nehru Medical college ,Sawangi(Meghe),Wardha MAHARASHTRA India 442001 
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 Maitri Patel  Jawaharlal Nehru Medical College  Department of Anaesthesiology ,sawangi(Meghe) ,Wardha , Maharashtra Wardha MAHARASHTRA 442001
Wardha
MAHARASHTRA 
9033004558

patelmaitrii26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Cancer patients requiring chemotherapy treatment and having pain
Being followed by the hospital oncology department
 
 
ExclusionCriteria 
Details  Cancer patients with pain in the terminal stage of the disease
Mentally retarded patients
Patients with cognitive dysfunction
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage and proportion of cancer patients undergoing chemotherapy reporting sensorial, emotional, evaluative and miscellaneous characteristics of pain by McGill Pain Questionnaire  At the baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Socio demographic and clinical determinants of pain  At the baseline. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   26/04/2024 
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 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  

1)  Cases of cancer have been increasing in recent years becoming a serious public health problem. Cancer pain is one of the symptoms that most frequently reported . Cancer pain during chemotherapy is a complex symptom, where usually the patient experiences different types of pain, in various intervals and intensity that reduces the quality of life.

2)  Cancer pain has multifaceted aspects, which takes into consideration not only the conditions of the disease but also the treatment, psycho-emotional and socio-economic factors, the habits of life and the experiences of each patient, becoming a challenge for the healthcare team.

3)  Even in an attempt to control pain, its prevalence is still high and patients experiences it during chemotherapy. This has led to greater attention to pain symptom in recent years.

4)   Despite the various methods available to manage it, the relief of pain however is insufficient not reaching acceptable levels. So, assessment of cancer pain must be a priority action for providing pain relief.

5)  Several pain assessment tools are used worldwide for assessing cancer pain. There is no universally accepted tool for the assessment of cancer pain. The frequently used pain assessment tools are visual analogue scale (VAS), the Numerical Rating Scale (NRS), and the Verbal Rating Scale (VRS).The above-mentioned are unidimensional pain scales which evaluate only one dimension of pain that is the pain severity or intensity.

Assessment and the qualitative perception of pain in cancer patients are important because of the variation in pain intensity, etiology and location. Multidimensional pain scales are assess not only the intensity of pain but also give an insight into the interference of pain with various aspects of daily living such as general activity, sleep, mood, and appetite. The McGill Pain Questionnaire (MPQ) is commonly used multidimensional pain scale. 
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