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CTRI Number  CTRI/2023/02/049409 [Registered on: 02/02/2023] Trial Registered Prospectively
Last Modified On: 10/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Music therapy and relaxation-visualization techniques for managing mask anxiety in head and neck cancer patients 
Scientific Title of Study   To Manage Mask Anxiety in Head & Neck Cancer patients (HNC) undergoing Radiation using Music Therapy & Relaxation- Visualization technique: A Randomized Control Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol: PO13, ICF Version 1.0 dated 28/December/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Poonam Tandiya 
Designation  Sr. Physiotherapist 
Affiliation  HCG NCHRI Nagpur 
Address  Physiotherapy Department, 2nd floor, HCG NCHRI, Mouja Wanjri Khasra No.50, 51 Ring Road Near Automotive Square Kalam Bande Nawaz Nagar, Binaki, Nagpur, Maharashtra 440026

Nagpur
MAHARASHTRA
440017
India 
Phone  9730926110  
Fax    
Email  physio.nagpur@hcgel.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Poonam Tandiya 
Designation  Sr. Physiotherapist 
Affiliation  HCG NCHRI Nagpur 
Address  Physiotherapy Department, 2nd floor, HCG NCHRI, Mouja Wanjri Khasra No.50, 51 Ring Road Near Automotive Square Kalam Bande Nawaz Nagar, Binaki, Nagpur, Maharashtra 440026

Nagpur
MAHARASHTRA
440017
India 
Phone  9730926110  
Fax    
Email  physio.nagpur@hcgel.com  
 
Details of Contact Person
Public Query  
Name  Dr Poonam Tandiya 
Designation  Sr. Physiotherapist 
Affiliation  HCG NCHRI Nagpur 
Address  Physiotherapy Department, 2nd floor, HCG NCHRI, Mouja Wanjri Khasra No.50, 51 Ring Road Near Automotive Square Kalam Bande Nawaz Nagar, Binaki, Nagpur, Maharashtra 440026

Nagpur
MAHARASHTRA
440017
India 
Phone  9730926110  
Fax    
Email  physio.nagpur@hcgel.com  
 
Source of Monetary or Material Support  
HCG NCHRI Cancer Center, Nagpur, Maharashtra, India 
 
Primary Sponsor  
Name  HCG NCHRI Cancer Center Nagpur 
Address  Mouja Wanjri Khasra No.50, 51 Ring Road Near Automotive Square Kalam Bande Nawaz Nagar, Binaki, Nagpur, Maharashtra 440026 
Type of Sponsor  Research institution and hospital 
 
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 Poonam Tandiya  HCG NCHRI Cancer Centre , Nagpur  Physiotherapy department, 2nd floor, HCG NCHRI Cancer Center, Mouja Wanjri Khasra No.50, 51 Ring Road Near Automotive Square Kalam Bande Nawaz Nagar, Binaki, Nagpur, Maharashtra 440026
Nagpur
MAHARASHTRA 		 9730926110

physio.nagpur@hcgel.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HCG NCHRI Cancer Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Patients in the control group will receive counselling that is offered routinely as a part of their treatment. 
Intervention  Music Therapy and Relaxation-Visualization technique.  The goal of interventions will be to reduce mask anxiety of patients and make them habitual and comfortable while wearing mask. Counselling: On the 1st day of RT, counselling will be done by clinical psychologist, patient counselor and Radiation oncologist. The patients will be explained regarding molding of mask and RT, so that they will become comfortable with treatment. Relaxation Visualization: A yoga therapist will brief the patients regarding relaxation-visualization technique on 1st day of RT followed by daily self-practice by patients on the remaining days. Patients will be asked to imagine pleasant events and images during RT while listening to the music. Music Therapy: Relaxing soft instrumental music and comfort sounds will be played in the background on speakers during the patients molding of mask and 1st 5 days of RT. The music will be played throughout the session. The music will be meditative music which will be, slow and flowing, relaxing music, a tempo of 60–80 beats per minute, instrumental with no lyrics and volume level of 50–60 db. Total duration of intervention will be 20 minutes /day for 1st 5 days of radiation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients diagnosed with head and neck cancer and undergoing radiation therapy.
Between 18 to 65 years of age.
Distress Score of 4 and above using Modified Distress Scale- Mask anxiety
Functional ability as per ECOG system, score 0 to 1
Non advanced stages of cancer. 
 
ExclusionCriteria 
Details  Severe cognitive limitations.
Patients with Brain Metastasis.
Major Psychiatric and neurological diseases.
Vision and hearing impairments.
Language difficulty.
Severe Physical deformities.
Advanced and Palliative Stages of Cancer. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Modified Distress Thermometer Score reduced after 5 days of music therapy and relaxation visualization.

 		 5 days of intervention.

 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable

 		 Not Applicable 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   09/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
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 - 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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, double group (control and intervention), single centre  trial comparing the effect of music therapy and relaxation- visualization technique on head and neck cancer patients undergoing radiation therapy (for 1st 5 days) for 6 months in 216 patients in HCG NCHRI Cancer Centre in India.  The outcome measures will be reduction in mask anxiety during 1st 5 days of radiation in head and neck cancer patients using music therapy and relaxation- visualization technique. 
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