CTRI Number |
CTRI/2018/09/015801 [Registered on: 24/09/2018] Trial Registered Prospectively |
Last Modified On: |
28/11/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Process of Care Changes |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Trial on the Effect of Indian Classical music on Head and Neck Cancer patients. |
Scientific Title of Study
|
A Randomized Controlled Trial On The Effect of Indian Classical Music For Chemotherapy and Radiotherapy Induced Anxiety, Pain and Mood Disturbance in Head and Neck Cancer - A Pilot Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
P U Prakash Saxena |
Designation |
Professor and Head of the Department |
Affiliation |
Kasturba Medical College, Mangalore |
Address |
Department of Radiotherapy and Oncology, Kasturba Medical College and Hospital, Attavar, Mangalore, Manipal Academy of Higher Education, Karnataka.
Dakshina Kannada KARNATAKA 575002 India |
Phone |
9008761002 |
Fax |
|
Email |
pu.saxena@manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
P U Prakash Saxena |
Designation |
Professor and Head of the Department |
Affiliation |
Kasturba Medical College, Mangalore |
Address |
Department of Radiotherapy and Oncology, Kasturba Medical College and Hospital, Attavar, Mangalore, Manipal Academy of Higher Education, Karnataka.
Dakshina Kannada KARNATAKA 575002 India |
Phone |
9008761002 |
Fax |
|
Email |
pu.saxena@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
P U Prakash Saxena |
Designation |
Professor and Head of the Department |
Affiliation |
Kasturba Medical College, Mangalore |
Address |
Department of Radiotherapy and Oncology, Kasturba Medical College and Hospital, Attavar, Mangalore, Manipal Academy of Higher Education, Karnataka.
Dakshina Kannada KARNATAKA 575002 India |
Phone |
9008761002 |
Fax |
|
Email |
pu.saxena@manipal.edu |
|
Source of Monetary or Material Support
|
Manipal Academy of Higher Education internal funding for research |
|
Primary Sponsor
|
Name |
Manipal Academy of Higher Education internal funding for research |
Address |
Kasturba Medical College, Manipal Academy of Higher Education, Mangalore. |
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 P U Prakash Saxena |
Department of Radiotherapy, Ground floor,Kasturba Medical College and Hospital Attavar. |
Department of Radiotherapy
Dakshina Kannada KARNATAKA |
9008761002
pu.saxena@manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba Medical College, Mangalore |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Indian classical music therapy |
Cases will listen to Indian classical music using earphones for about half an hour for 5 days a week. Selection of specific “raga†would be according to the inherited knowledge prevailed in centuries in the Indian classical music. The music is relaxing and will be played in their choice of volume level and location (bedside or soundproof room inside the hospital). Analysis using questionnaire will be done at 0th 3rd and 5th week of their radio therapy. |
Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
All patients who are diagnosed with Head and neck cancer - squamous cell carcinoma who are treated with chemotherapy an radiotherapy at Kasturba Medical College and Hospital. |
|
ExclusionCriteria |
Details |
This study excludes patients who are less than 18 years of age, having a hearing deficit, not suitable for chemotherapy and radiotherapy and not willing to give consent. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reduction of the chemotherapy- radiotherapy induced anxiety, pain and mood disturbance after listening to the Indian classical music. |
0th 3rd and 5th week of study. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction of anxiety, pain and mood disturbance |
0th,3rd and 5th week. |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/10/2018 |
Date of Study Completion (India) |
26/08/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
26/08/2019 |
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized controlled trial among patients who are treated with radiation therapy for diagnosed head and neck cancer at tertiary oncology care centre KMCH, Attavar in Mangalore, South India. Selection of specific “raga†would be according to the inherited knowledge prevailed in centuries in the Indian classical music. This study includes all the patients who were diagnosed with Head and neck squamous cell carcinoma and treated under chemotherapy and radiotherapy at Kasturba Medical College and Hospital. The diagnosis of Head and neck cancer established by histopathologic study. Demographic details, clinical staging, comorbidity status, treatment, recurrence, follow up data, would also be analyzed along with music therapy outcome. This study excludes those patients who were less than 16 years of age, having hearing deficit, not suitable for CT-R and not willing to consent. Our objectives are to study the effect of specifically selected “raga†in Indian classical music in patients undergoing CT-RT (chemo-RT) for head and neck cancer, analyze the therapeutic use of specific “raga†in Indian classical music in cancer patients and to study the music therapy (specific “raga†in Indian classical music) outcomes. This study would probe into the therapeutic use of Indian classical music among all the head and neck cancer patients taking radiotherapy from the centers of analysis so that the fraction of patients getting this music therapy can be analyzed along. We also look forward to see whether the outcomes had changed with the music therapy which is serious concern in regard to the survival. We will analyze the cases and controls at 0th, 3rd and the 5th/7th week of Radiation using pretested semi-structured questionnaires (Hamilton anxiety rating scale, Hospital anxiety and depression scale and visual analogue scale for pain). The data will be analyzed using SPSS version 17. Results will be expressed in proportions and standard derivations. Chi-square test and t test will be used to test statistical significance. P value of <0.05 will be considered significant. |