FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077422 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Crossover Trial 
Public Title of Study   The impact of classical music on pain, anxiety, breathing, and daily living activities in cancer patients before surgery - a randomised controlled study. 
Scientific Title of Study   Combined Effect of Classical Music on Breathing, Pain, Anxiety and Activities of Daily Living in Pre-Operative Cancer Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  shubhada jadhav 
Designation  student 
Affiliation  Dr D.Y patil college of physiotherapy 
Address  Dr D.Y Patil college of physiotherapy, sant tukaram nagar, Pimpri Chinchwad. Third-floor cardiorespiratory department. room n0 3

Pune
MAHARASHTRA
411018
India 
Phone  07420084613  
Fax    
Email  shubhada0305@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayura Deshmukh 
Designation  Head of department 
Affiliation  Dr D.Y patil college of physiotherapy 
Address  Dr D.Y Patil college of physiotherapy, sant tukaram nagar, Pimpri Chinchwad. Third-floor cardiorespiratory department. room n0 3

Pune
MAHARASHTRA
411018
India 
Phone  8149376929  
Fax    
Email  mayuradeshmukh04@gmail.com  
 
Details of Contact Person
Public Query
 
Name  shubhada jadhav 
Designation  student 
Affiliation  Dr D.Y patil college of physiotherapy 
Address  Dr D.Y Patil college of physiotherapy, sant tukaram nagar, Pimpri Chinchwad. Third-floor cardiorespiratory department. room n0 3

Pune
MAHARASHTRA
411018
India 
Phone  7420084613  
Fax    
Email  shubhada0305@gmail.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  Dr DY Patil Vidyapeeth 
Address  Dr D. Y Patil college of physiotherapy, sant tukaram nagar, pimpri, India , 411018 
Type of Sponsor  Other [self] 
 
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 
Shubhada jadhav  Dr. D.Y patil college of physiotherapy  Dr D.Y Patil college of physiotherapy, sant tukaram nagar, Pimpri Chinchwad. Third-floor cardiorespiratory department. room n0 3 pune division
Pune
MAHARASHTRA 
7420084613

shubhada0305@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional committee Dr D.Y Patil   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indian classical music  Regarding ethical considerations, it is necessary to obtain approval from the ethics committee to guarantee that the research project adheres to ethical principles and protects the rights of participants. Before starting the study, we need participant consent. Before deciding to participate in the research, it is important to ensure that participants completely understand the studys nature, includinginformationaboutitspotentialadvantagesanddangers.Wewillmakeeveryeffortto ensure the confidentiality of the customers personal information. Evaluation on a broad scale: Take down demographic information such as age, gender, the type of cancer, and the length of time the patient has been ill. In addition, the examination includes a review of the individuals medical history, pain, and anxiety, an evaluation of the individuals respiratory function, and an assessment of their activities of daily living (ADL) using the Lawton Brody scale. All of these components will be included in the evaluation. Both groups will receive the same progressive relaxation techniques and breathing exercises as part of the intervention. We will deliver a classical music therapy session to the experimental group using headphones. We will perform four brief sessions of classical music every eight hours, each lasting twenty minutes for a span of 48 hrs To complete the data collection and analysis process, we must collect baseline data before and after the intervention. To get a better understanding of the differences and similarities between the control group and the intervention, we will do a statistical analysis of the data. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed with cancer. Preoperative population with cancer.Population of India. Individuals experience spontaneous discomfort, heightened anxiety, and impaired performance in everyday tasks. 
 
ExclusionCriteria 
Details  Patients who are sub-conscious. Patients suffering from auditory impairments. Patients with impaired communication abilities. Individuals with deficits in comprehension. Oncology patients receiving radiation therapy 
 
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 
Pain, anxiety, breathing and activities of daily living  48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
anxiety, breathing & activities of daily living  48 hours 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   07/12/2024 
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  
Before starting the study, we need participant consent. Before deciding to participate in the research, it is important to ensure that participants completely understand the study’s nature, including information about its potential advantages and dangers. We will make every effort to ensure the confidentiality of the customer’s personal information. Evaluation on a broad scale: Take down demographic information such as age, gender, the type of cancer, and the length of time the patient has been ill. In addition, the examination includes a review of the individual’s medical history, pain, and anxiety, an evaluation of the individual’s respiratory function, and an assessment of their activities of daily living (ADL) using the Lawton Brody scale. All of these components will be included in the evaluation. Both groups will receive the same progressive relaxation techniques and breathing exercises as part of the intervention. We will deliver a classical music therapy session to the experimental group using headphones. We will perform four brief sessions of classical music every eight hours, each lasting twenty minutes for 48 hrs To complete the data collection and analysis process, we must collect baseline data before and after the intervention. To get a better understanding of the differences and similarities between the control group and the intervention, we will do a statistical analysis of the data.
 
Close