| 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
|
|
|
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
|
|
|
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. |