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CTRI Number  CTRI/2025/05/087576 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 25/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Using vibration and cold application can help to reduce pain when giving an chemotherapy injection into the muscle in cancer patients  
Scientific Title of Study   A Randomized control trial to compare the effectiveness of thermo mechanical stimulation versus standard treatment on reduction of pain level among cancer patients receiving intra-muscular chemotherapy injections 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paresh Kumar Meghwal 
Designation  Student 
Affiliation  College of Nursing,AIIMS Delhi 
Address  Porta cabin 2 college of nursing All India institute of medical science New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  8003908477  
Fax    
Email  pareshmeghwal48@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashi Mawar 
Designation  Associate Professor  
Affiliation  College of Nursing,AIIMS Delhi 
Address  Room number 4 college of nursing All India institute of medical science New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  8800228317  
Fax    
Email  drshashimawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Paresh Kumar Meghwal 
Designation  Student 
Affiliation  College of Nursing,AIIMS Delhi 
Address  Porta cabin 2 college of nursing All India institute of medical science New Delhi 110029

New Delhi
DELHI
110029
India 
Phone  8003908477  
Fax    
Email  pareshmeghwal48@gmail.com  
 
Source of Monetary or Material Support  
ROOM NO-4,2ND FLOOR,COLLEGE OF NURSING,AIIMS NEW DELHI,INDIA,PIN CODE-110029  
 
Primary Sponsor  
Name  Paresh Kumar Meghwal 
Address  Porta cabin 2 college of nursing All India institute of medical science New Delhi 110029  
Type of Sponsor  Other [None] 
 
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 Shashi Mawar  Collge of Nursing, AIIMS New Delhi  Porta cabin 2, 2 nd floor of College of Nusing, AIIMS New Delhi
South
DELHI 		 8800228317

pareshmeghwal48@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C959||Leukemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Treatment(Cold Therapy)  Application of Cold therapy to reduce pain. 
Intervention  Thermo-mechanical Stimulation  Thermo-mechanical stimulation is using to reduce pain during intramuscular chemotherapy injection in cancer patients Duration of intervention is 1-2 minutes 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Cancer patients receiving intramuscular chemotherapy injections.
2. Patient’s age between 6 to 60 Year of age.
3.Willingness of both the patient and family to participate in the study.
 
 
ExclusionCriteria 
Details  1.Patients with any skin abrasion and skin breakdown where the device to be applied.
2.Patient diagnosed with nerve damage at injection site.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To reduce pain level.  1-2 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/08/2025 
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="5"
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-identification.

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pareshmeghwal48@gmail.com].

  6. For how long will this data be available start date provided 30-11-2026 and end date provided 19-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A RCT is conducted with the aim of reducing pain level among cancer patients receiving intramuscular chemotherapeutic injection.Sample population for the study is cancer patient between 6 to 60 years of age receiving intramuscular chemotherapeutic injection at IRCH , AIIMS Delhi.Sampling technique  is consecutive sampling with random allocation by computer generated random numbers.Data will be collected by administering demographic datasheet to collect demographic data then assess assess the pain level by using pain assessment tools i.e. wong baker Faces scale and numerical rating scale.Also assess the patient  satisfaction level by using patient satisfaction tool.Data will be analysed through descriptive and inferential statistics. 
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