| 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
|
|
|
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
|
|
|
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
|
|
|
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. |