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CTRI Number  CTRI/2024/01/061077 [Registered on: 02/01/2024] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to observe the effect of pre-recorded lullaby in a childs own mothers voice on radiotherapy procedures which are under sedation. 
Scientific Title of Study   The Effect of Pre-recorded Lullaby in a Childs Own Mothers Voice on Radiotherapy Procedure under Sedation : An Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Uddalak Chattopadhyay 
Designation  Associate Professor Department of Anaesthesiology Critical care and Pain 
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 
Address  Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 221005 Uttar Pradesh India

Varanasi
UTTAR PRADESH
221005
India 
Phone  8617279293  
Fax    
Email  uddalak@mpmmcc.tmc.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Uddalak Chattopadhyay 
Designation  Associate Professor Department of Anaesthesiology Critical care and Pain 
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 
Address  Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 221005 Uttar Pradesh India


UTTAR PRADESH
221005
India 
Phone  8617279293  
Fax    
Email  uddalak@mpmmcc.tmc.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Uddalak Chattopadhyay 
Designation  Associate Professor Department of Anaesthesiology Critical care and Pain 
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 
Address  Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 221005 Uttar Pradesh India


UTTAR PRADESH
221005
India 
Phone  8617279293  
Fax    
Email  uddalak@mpmmcc.tmc.gov.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital  
Address  Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 221005 Uttar Pradesh India 
Type of Sponsor  Government medical college 
 
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 Uddalak Chattopadhyay  HBCH and MPMMCC Radiotherapy suite Varanasi  Department of Anaesthesiology Critical care and Pain 4th Floor OT Complex Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital Varanasi 221005 Uttar Pradesh India
Varanasi
UTTAR PRADESH 		 8617279293

uddalak@mpmmcc.tmc.gov.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MPMMCC HBCH TMC Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C768||Malignant neoplasm of other specified ill-defined sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Playing prerecorded lullaby in patients own mothers voice along with routine sedatives for anxiolysis and immobilization during radiotherapy is already an existing practice in our department While some of the anesthesiologists are using this methodology rest of them are still following the conventional method of delivery of sedatives only without playing the lullaby In this observational study we will not actively intervene and will only document the routine practices and will collect data and analyze them Since there is no preexisting data regarding benefit of using prerecorded lullaby in patients own mothers voice during radiotherapy we wish to conduct this exploratory observational study Result of this observational study will guide us in conducting randomized controlled trial on this same matter in future Institutional Ethics Committee has also agreed upon the nature of this study 
Comparator Agent  NIL  Playing prerecorded lullaby in patients own mothers voice along with routine sedatives for anxiolysis and immobilization during radiotherapy is already an existing practice in our department While some of the anesthesiologists are using this methodology rest of them are still following the conventional method of delivery of sedatives only without playing the lullaby In this observational study we will not actively intervene and will only document the routine practices and will collect data and analyze them Since there is no preexisting data regarding benefit of using prerecorded lullaby in patients own mothers voice during radiotherapy we wish to conduct this exploratory observational study Result of this observational study will guide us in conducting randomized controlled trial on this same matter in future Institutional Ethics Committee has also agreed upon the nature of this study 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  3.00 Year(s)
Gender  Both 
Details  Inclusion Criteria: Pediatric patients of both the sex less than three years of age undergoing radiotherapy. 
 
ExclusionCriteria 
Details  Exclusion Criteria:
Patients with a history of severe cognitive impairments or hearing impairments that could affect their response to the lullaby will be excluded.

Patients unfit for radiotherapy under sedation (eg. Inadequate NBM hours, Acute lower respiratory tract infection, fever) will be excluded.

Patients with prolonged fasting period (more than 8 hours) will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the number of episodes of intra-procedure spontaneous movements under sedation, interfering with radiotherapy treatment (observed on telemetry CCTV monitor).  During the procedure of radiotherapy 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the total dose requirement (per kg body weight) of general anesthetics (midazolam and ketamine) per episode of radiotherapy.  During radiotherapy 
To observe immediate post procedure sedation status as per AVPU scale after each episode of radiotherapy  Immediate post radiotherapy 
To observe recovery time for each patient after completion of radiotherapy  after completion of radiotherapy at recovery room 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   08/01/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
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   Though process of delivering radiotherapy is painless, sedation is often required for pediatric patients undergoing radiotherapy to ensure their comfort, anxiety reduction, and immobilization during the procedure. However, the repeated use of general anesthetics, such as benzodiazepines and ketamine, in pediatric patients has raised concerns about potential long-term neurocognitive effects on the developing brain. While anesthesia-sparing distraction methods have been attempted, they are challenging to implement successfully in children under three years of age.Music therapy has been traditionally used to calm anxious patients.Recently, in our centre we have started playing pre-recorded lullaby in patient’s own mothers voice as an adjuvant method along with routine sedatives to achieve anxiolysis and immobilisation during radiotherapy. While some of the anaesthesiologists are adopting this new methodology, rest of them are still following the conventional method (delivery of sedatives only, without playing the lullaby).

In this prospective observational cohort study, we aim to observe the effect of playing a prerecorded lullaby in the patient’s own mother’s voice as an adjuvant method alongside routine sedation to achieve anxiolysis and immobilization during radiotherapy and compare them with the conventional general anesthesia technique.

 
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