| CTRI Number |
CTRI/2017/09/009919 [Registered on: 26/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/04/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [music therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of music on pain, heart rate, blood pressure, temperature, anxiety and quality of life among patients with cancer during chemotherapy. |
|
Scientific Title of Study
|
Effect of Music Therapy on bio-physiological and psychological outcomes during chemotherapy
among patients with cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Imran |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Nursing College
Yenepoya University
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880749477 |
| Fax |
|
| Email |
syed_vinu@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Imran |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Nursing College
Yenepoya University
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880749477 |
| Fax |
|
| Email |
syed_vinu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Imran |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya University |
| Address |
Yenepoya Nursing College
Yenepoya University
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9880749477 |
| Fax |
|
| Email |
syed_vinu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Syed Imran |
| Address |
Assistant Professor
Yenepoya University
Deralakatte
Managluru
575018 |
| 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 |
| Dr Syed Imran |
Yenepoya Medical College Hospital |
Department of Oncology
Medical Oncology Unit
7th Floor
Dakshina Kannada
KARNATAKA |
9880749477
syed_vinu@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music therapy |
Instrumental Music |
| Comparator Agent |
Standard care alone |
standard routine care |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Having II and III stage of cancer
2. Willing to participate in the study
3. Available at the time of date collection
|
|
| ExclusionCriteria |
| Details |
1. Having hearing problems.
2. Having head and neck cancer
4. Having diabetes, hypertension and thyroid problems.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
bio-physiological outcomes such as Temperature, Heart rate, blood pressure, Salivary cortisol and salivary amylase levels.
psychological outcomes such as anxiety and quality of life |
on the first day of chemotherapy cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
bio-physiological outcomes such as Temperature, Heart rate, blood pressure, Salivary cortisol and salivary amylase levels.
psychological outcomes such as anxiety and quality of life |
on the eighth day of chemotherapy cycle |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
14/11/2016 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to make the patients with cancer feel comfortable and to improve the quality of life to some extent in terms of bio-physiological (body temperature, pain, blood pressure, heart rate, salivary alpha amylase, salivary cortisol) and psychological (anxiety, fatigue, quality of life/satisfaction) outcomes by providing music only during the chemotherapy receiving for the first time.
Following hypothesis will be tested at 0.05 level of significance H1: The mean post-test scores of bio-physiological outcome (Body temperature) will be significantly lower than the mean pretest score. H2: The mean post-test scores of bio-physiological outcome (Blood pressure) will be significantly lower than the mean pretest score. H3: The mean post-test scores of bio-physiological outcome (Heart rate) will be significantly lower than the mean pretest score. H4: The mean post-test scores of bio-physiological outcome (salivary amylase) will be significantly lower than the mean pretest score. H5: The mean post-test scores of bio-physiological outcome (Salivary cortisol) will be significantly lower than the mean pretest score. H6: The mean post-test scores of psychological outcomes (Anxiety) will be significantly lower than the mean pretest score. H7: The mean post-test scores of psychological outcomes (Fatigue) will be significantly lower than the mean pretest score. H8: The mean post-test scores of psychological outcomes (Quality of life) will be significantly higher than the mean pretest score. H9: There will be significant association between bio-physiological outcomes and the selected demographic variables. H10: There will be significant association between psychological outcomes and the selected demographic variables.
|