| CTRI Number |
CTRI/2025/09/095334 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY THE EFFECT OF BINURAL MUSICA AND MIDAZOLAM ON ANXIETY WHILW UNDERGOING OPERATION , ON LOWERLIMB ORTHOPAEDIC CASES UNDER SPINAL ANAESTHESIA |
|
Scientific Title of Study
|
A prospective comparative study of the effect of binaural music versus midazolam on intraoperative anxiety in patients undergoing lower limb orthopedic surgery under spinal anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Laxmi mathapati |
| Designation |
Junior resident |
| Affiliation |
BLDEA(deemed to be university) |
| Address |
Dept of Anaesthesia
Shri B M PATIL Medical College and research centre vijayapura
Dept of Anaesthesia
Shri B M PATIL Medical College and research centre vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9535113222 |
| Fax |
|
| Email |
laxmipmathapati999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIJAYAKUMAR T K |
| Designation |
Proff dept of Anaesthesia |
| Affiliation |
BLDEA(deemed to be university) |
| Address |
Dept of ANAESTHESIA
SHRI B M PATIL MEDICAL COLLEGE VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
vijaykumar.tk@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Laxmi mathapati |
| Designation |
Junior resident |
| Affiliation |
BLDEA(deemed to be university) |
| Address |
Dept, Anaesthesia
Shri B M Patil medical College and research centre
Vijayapura
Dept, Anaesthesia
Shri B M Patil medical College and research centre
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9535113222 |
| Fax |
|
| Email |
laxmipmathapati999@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI B M PATIL MEDICAL COLLEGE AND RESEARCH CENTER
VIJAYAPURA
586103 |
|
|
Primary Sponsor
|
| Name |
LAXMI P MATHAPATI |
| Address |
Shri B M Patil medical college and research centre vijayapura
Karnataka 586103 India |
| 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 |
| Laxmi P Mathapati |
Shri B M Patil medical college and research centre vijayapura |
Male/Female
Orthopedic ward
402 Ward number
Bijapur
KARNATAKA |
9535113222
laxmipmathapati999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE(DEEMED TO BE UNIVERSITY) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
binaural beat music intraoperatively with noise cancellation headphones to reduce anxiety |
Pre-Anaesthetic Evaluation:
• History: Information regarding any pre-existing medical conditions, prior surgical experiences, exposure to anaesthesia, and past hospitalizations will be gathered.
• Clinical Assessment: Evaluation of the patients overall health. Baseline vital signs, including heart rate, systolic and diastolic blood pressure, respiratory rate, and mean arterial blood pressure, will be documented.
Pre-operatively:
- Preoperative STAI-6 scores will be taken to know the anxiety of patient.
Intra-operatively:
- Patients were given spinal block by using 0.5% hyperbaric bupivacaine.
- After patients were put on noise cancelling head phones and binaural music was played in group I, in group II intravenous midazolam 0.02mg/kg will be given group III is taken as control group without any music or midazolam.
- The hemodynamic parameters were noted at 5, 10 ,20, 40 ,60 and every 20mins till surgery gets over.
- Ramsay sedation score were noted every half an hour of surgery.
- The noted parameters are SBP, DBP, MBP, HR.
Post-operatively:
- Post operative STAI-6 scores will be taken to know the anxiety and VAS-S will be taken to know satisfaction of patient.
|
| Comparator Agent |
giving inj midazolam
0.02mg/kg reduce to anxiety intraoperatively |
History: Information regarding any pre-existing medical conditions, prior surgical experiences, exposure to anaesthesia, and past hospitalizations will be gathered. • Clinical Assessment: Evaluation of the patients overall health. Baseline vital signs, including heart rate, systolic and diastolic blood pressure, respiratory rate, and mean arterial blood pressure, will be documented. Pre-operatively: - Preoperative STAI-6 scores will be taken to know the anxiety of patient. Intra-operatively: - Patients were given spinal block by using 0.5% hyperbaric bupivacaine. - After patients were put on noise cancelling head phones and binaural music was played in group I, in group II intravenous midazolam 0.02mg/kg will be given group III is taken as control group without any music or midazolam. - The hemodynamic parameters were noted at 5, 10 ,20, 40 ,60 and every 20mins till surgery gets over. - Ramsay sedation score were noted every half an hour of surgery. - The noted parameters are SBP, DBP, MBP, HR. Post-operatively: - Post operative STAI-6 scores will be taken to know the anxiety and VAS-S will be taken to know satisfaction of patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults of either sex age between 18 to 60 years
ASA grade I and II
Patients undergoing lowerlimb orthopedic surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with hearing impairment
patients with spinal deformity and mental illness
pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the difference of the effect of binaural music and midazolam on patients anxiety intraoperatively |
Baseline,
5mins, 10mins, 30mins,
1hr and immediate post operative
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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)
|
04/10/2025 |
| 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 Applicable |
| 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
|
Pre-Anaesthetic Evaluation: History: Information regarding any pre-existing medical conditions, prior surgical experiences, exposure to anaesthesia, and past hospitalizations will be gathered. Clinical Assessment: Evaluation of the patient’s overall health. Baseline vital signs, including heart rate, systolic and diastolic blood pressure, respiratory rate, and mean arterial blood pressure, will be documented. Pre-operatively: Preoperative STAI-6 scores will be taken to know the anxiety of patient. Intra-operatively: Patients were given spinal block by using 0.5% hyperbaric bupivacaine. After patients were put on noise cancelling head phones and binaural music was played in group I, in group II intravenous midazolam 0.02mg/kg will be given group III is taken as control group without any music or midazolam. The hemodynamic parameters were noted at 5, 10 ,20, 40 ,60 and every 20mins till surgery gets over. Ramsay sedation score were noted every half an hour of surgery. The noted parameters are SBP, DBP, MBP, HR. Post-operatively: Post operative STAI-6 scores will be taken to know the anxiety and VAS-S will be taken to know satisfaction of patient. |