Trial on the Effect of Indian Classical music on Head and Neck Cancer patients.

Completed

Conditions: Malignant neoplasm of oropharynx,unspecified,

Registration Number: CTRI/2018/09/015801

Lead Sponsor: Manipal Academy of Higher Education internal funding for research

Brief Summary: 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 *â€œragaâ€* 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 *â€œragaâ€* in Indian classical music in patients undergoing CT-RT (chemo-RT) for head and neck cancer, analyze the therapeutic use of specific *â€œragaâ€* in Indian classical music in cancer patients and to study the music therapy (specific *â€œragaâ€* 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Reduction of anxiety, pain and mood disturbance	0th,3rd and 5th week.

Trial Locations

Locations (1): Department of Radiotherapy, Ground floor,Kasturba Medical College and Hospital Attavar.
🇮🇳
Kannada, KARNATAKA, India
Department of Radiotherapy, Ground floor,Kasturba Medical College and Hospital Attavar.
🇮🇳Kannada, KARNATAKA, India
Dr P U Prakash Saxena
Principal investigator
9008761002
pu.saxena@manipal.edu