| CTRI Number |
CTRI/2024/09/074478 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral
Other (Specify) [Binaural Beat Music] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on effect of binaural beat music -two tones each of different frequency in different ear when listened creates an additional tone by the brain -its effects on anxiety and stress on patients undergoing thigh bone fracture surgery |
|
Scientific Title of Study
|
Effect of Binaural Beat Music on Perioperative Anxiety and Stress among patients undergoing Femur bone Fracture Surgery under Spinal Anesthesia: A prospective randomized 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 Riya Rose Jojo |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Bhopal Campus, Saket Nagar, Bhopal, Madhya Pradesh, India
462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9424599125 |
| Fax |
|
| Email |
riyarosejojo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Prakash Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences,Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, India
462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9425609647 |
| Fax |
|
| Email |
jaiprakash.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jai Prakash Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences,Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, India
462026
Bhopal
MADHYA PRADESH
462026
India |
| Phone |
9425609647 |
| Fax |
|
| Email |
jaiprakash.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS BHOPAL-non funded
Saket Nagar
Bhopal
Madhya Pradesh |
| ICMR PG THESIS PROGRAMME GRANT
No-HRD-Head/PG thesis program/2023-24
Department of Health Research
2nd floor, IRCS Building 1
Red Cross Road, New Delhi 110001
|
|
|
Primary Sponsor
|
| Name |
AIIMS BHOPAL |
| Address |
Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal,Madhya Pradesh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Riya Rose Jojo |
AIIMS Bhopal |
Operation Theatre, Department Of Anaesthesiology, AIIMS Bhopal
Bhopal
MADHYA PRADESH |
9424599125
riyarosejojo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Bhopal Institutional Human Ethics Committee - Student Research (IHEC-SR) |
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 effects on perioperative anxiety and stress among patients undergoing femur bone fracture surgery.(MUSIC group) |
An observer blinded to the groups will evaluate the anxiety levels in patients using STAI-6 score scale. Those belonging to the MUSIC group will be receiving binaural beat music intervention in preoperative period for 15 minutes which will also familiarize them with gadgets. On arrival in the operation theatre, after induction of anaesthesia with 0.5% Bupivacaine Heavy of appropriate dose and confirming the adequate dermatomal level of motor and sensory blockade, they will be receiving the binaural beat music via Bluetooth headphones for the entire duration of surgery. The intraoperative vital parameters and sedation requirements are recorded. On arriving to recovery room after surgery, salivary samples collected and post operative STAI-6 scores are assessed by observer blinded to group allocation. Saliva samples collected will be sent to Department Of Biochemistry AIIMS Bhopal where its stored at -80 degree Celsius ,thawed on ice, centrifuged at 150000 g for 5 minutes to precipitate mucins. Clear saliva will be collected and used for salivary cortisol estimation. |
| Comparator Agent |
Patients undergoing femur bone fracture surgery belonging to NON MUSIC group will receive routine standard care preoperatively and intraoperatively. |
An observer blinded to the groups will evaluate the anxiety levels in patients using STAI-6 score scale. Those belonging to the NON MUSIC group will be receiving standard care in preoperative period. On arrival in the operation theatre, after induction of anaesthesia with 0.5% Bupivacaine Heavy of appropriate dose and confirming the adequate dermatomal level of motor and sensory blockade, standard anaesthesia care continued in them. The intraoperative vital parameters and sedation requirements are recorded. On arriving to recovery room after surgery, salivary samples collected and post operative STAI-6 scores are assessed by observer blinded to group allocation. Saliva samples collected will be sent to Department Of Biochemistry AIIMS Bhopal where its stores at -80 degree Celsius ,thawed on ice, centrifuged at 150000 g for 5 minutes to precipitate mucins. Clear saliva will be collected and used for salivary cortisol estimation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA (American Society of Anaesthesiologists classification of physical status) grade 1,2 and 3 patients aged more than 18 years with upper limit of age 70 years of either sex with consent and those who understand Bluetooth / headphone noise cancellation gadgets comfortably undergoing femur bone fracture surgery under spinal anaesthesia in our institute. |
|
| ExclusionCriteria |
| Details |
Patients refusing informed consent
Contradications to spinal anaesthesia
Any treatment that affects physiological status or presence of psychiatric disorder
Patients with hearing impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison between STAI-6(State trait anxiety inventory) in both groups.
Salivary cortisol levels in response to neurohormonal response to surgery in both groups |
Baseline
By the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total sedation requirements in each group.
Difference in hemodynamic variables (Heart Rate, Mean Arterial Pressure, Diastolic and Systolic blood pressure) in both groups. |
Intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
04/10/2024 |
| 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="1"
Months="6"
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
|
Patients subjected to surgeries are exposed to intense anxiety and stress. Spinal anaesthesia further increases anxiety because patient is either awake or slightly sedated and exposed to multiple anxiety provoking visual and auditory stimuli. Perioperative anxiety and psychological stress lead to activation of HPA and sympathetic nervous system resulting in neurohormonal responses reflected in cortisol levels and causes hemodynamic instability. It calls for increased pharmacological interventions which might hinder recovery following anaesthesia and induce undesirable dose dependent cardiorespiratory and CNS depression. Extensive researches on efficacy of binaural beat music in anxiety, pain perception and relaxation has shed light to use it as an intervention to alleviate anxiety and physiological responses to surgery. Various studies have indicated the prevalence of anxiety highest with orthopedics procedures which uses hammers, drills and other louder instruments .Anxiety comparatively higher among patients who had femur bone procedures because of sudden constraints on movement couples with excruciating pain and quick medical process that decided the diagnosis and treatment course. Thus we decided to conduct a randomized control study on effects of binaural beat music on perioperative anxiety and stress in patients undergoing femur bone fracture surgery under spinal anesthesia. As salivary biomarkers have proven to be better than blood markers in stress related research ,the influence of binaural music on stress analyzed by salivary cortisol and perioperative anxiety in both groups compared using more objective scale such as State Trait Anxiety Inventory scoring scales. |