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CTRI Number  CTRI/2025/10/095549 [Registered on: 01/10/2025] Trial Registered Prospectively
Last Modified On: 01/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How Epidural Pain Relief During Labor, With or Without Music Therapy, Affects Newborns’ Metabolism: A Forward-Looking Comparison Study 
Scientific Title of Study   Neonatal Metabolic Effect Of Epidural Labor Analgesia With or without Music Therapy: A prospective, Randomised, comparative 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 M KRoja 
Designation  Junior Resident 
Affiliation  King Georges Medical University 
Address  King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), department of anesthesiology Chowk, Lucknow, Uttar Pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9791407805  
Fax    
Email  rojakarthikeyan27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M KRoja 
Designation  Junior Resident 
Affiliation  King Georges Medical University 
Address  King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), department of anesthesiology Chowk, Lucknow, Uttar Pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9791407805  
Fax    
Email  rojakarthikeyan27@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manoj Kumar Chaurasiya 
Designation  DNB Anaesthesia Associate Professor 
Affiliation  King Georges Medical University 
Address  King George Medical University, department of anesthesiology (Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chowk, Lucknow, Uttar Pradesh.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9506823989  
Fax    
Email  mchh3131@gmail.com   
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care King George Medical University Shah Mina Road Chowk Lucknow Uttar Pradesh India 226003  
 
Primary Sponsor  
Name  Dr Manoj Kumar Chaurasiya 
Address  King George Medical University Shah Mina Road Chowk Lucknow Uttar Pradesh India 226003 Department of Anaesthesiology and Critical Care room number 10 
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 M KRoja  King Georges Medical University  King Georges Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chowk, Lucknow, Uttar Pradesh.Department of anesthesiology and critical care
Lucknow
UTTAR PRADESH 		 9791407805

rojakarthikeyan27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King George Medical University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epidural Analgesia   Standard epidural analgesia with ropivacaine 0.1% + fentanyl 2 µg/ml (12 ml bolus, then continuous infusion). 
Comparator Agent  Epidural Analgesia with Music Therapy  Same epidural regimen plus instrumental piano music (60–80 bpm, 50–60 dB) via headphones from bolus initiation till delivery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  pregnant women above 18 years of age with singleton pregnancy, ASA physical status I and II, and cervical dilation greater than three centimeters. Written informed consent was obtained from all participants 
 
ExclusionCriteria 
Details  women with a history of previous caesarean section, those with complicated obstetric conditions such as twin pregnancy, antepartum hemorrhage, placenta previa, gestational diabetes, or moderate to severe preeclampsia, and women with pre-existing medical conditions likely to affect labour or neonatal outcomes. Participants with contraindications to epidural analgesia, hearing impairment, or refusal to listen to music were also excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Neonatal metabolic parameters (cord blood glucose, lactate, pH, base deficit), APGAR score at 1 & 5 minutes, and NICU admission.  at birth 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal and neonatal adverse events, if any, during labor and delivery.  whole intrapartum period 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   14/10/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This prospective randomized comparative study will be conducted in the Department of Anesthesiology in collaboration with Obstetrics and Gynecology at King George’s Medical University, Lucknow, over 18 months. Ninety primiparous women with singleton pregnancies in active labor will be randomized (computer-generated sequence, allocation concealed by SNOSE) into two groups: Group A receiving epidural analgesia alone (ropivacaine 0.1% + fentanyl 2 µg/ml) and Group B receiving epidural analgesia with adjunct music therapy (instrumental piano, 60–80 bpm, 50–60 dB). The primary outcome will be neonatal metabolic parameters (cord blood glucose, lactate, pH, base deficit), APGAR scores at 1 and 5 minutes, and NICU admission. Secondary outcomes include maternal satisfaction and any maternal or neonatal adverse events. The target sample size is 90 (45 per group). This open-label trial is categorized as Phase N/A. 
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