| CTRI Number |
CTRI/2024/05/067076 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on the effect of music therapy on anxiety, stress and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia. |
|
Scientific Title of Study
|
Effect of music therapy on anxiety, stress and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia: A randomized controlled 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 Thamaraikkannan |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai |
| Address |
Room;329
Department of anaesthesiology and critical care Upums Saifai Etawah
Uttar Pradesh
206130
india
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9655243726 |
| Fax |
|
| Email |
thamaraikannan3696@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha shukla |
| Designation |
Professor & HOD |
| Affiliation |
ttar Pradesh University of Medical Sciences, Saifai |
| Address |
Room no:329
Department of anaesthesiology and critical care Upums Saifai Etawah
Uttar Pradesh
206130
india
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha shukla |
| Designation |
Professor & HOD |
| Affiliation |
ttar Pradesh University of Medical Sciences, Saifai |
| Address |
Room no:329
Department of anaesthesiology and critical care Upums Saifai Etawah
Uttar Pradesh
206130
india
UTTAR PRADESH
206130
India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh university of medical sciences saifai etawah |
|
|
Primary Sponsor
|
| Name |
Uttar pradesh university of medical sceinces saifai etawah |
| Address |
Room no 329
Department of anaesthesiology and critical care Upums Saifai, Etawah
Uttar Pradesh
206130
india |
| Type of Sponsor |
Government medical college |
|
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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 Thamaraikkannan |
Uttar pradesh university of medical sciences saifai etawah |
Room no 329
Department of anaesthesiology and critical care Upums Saifai, Etawah
Uttar Pradesh
206130
india
Etawah
UTTAR PRADESH |
9655243726
thamaraikannan3696@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (2) ICD-10 Condition: S878||Crushing injury of lower leg, (3) ICD-10 Condition: S880||Traumatic amputation at knee level, (4) ICD-10 Condition: S723||Fracture of shaft of femur, (5) ICD-10 Condition: S823||Fracture of lower end of tibia, (6) ICD-10 Condition: S824||Fracture of shaft of fibula, (7) ICD-10 Condition: S818||Open wound of lower leg, (8) ICD-10 Condition: S730||Subluxation and dislocation of hip, (9) ICD-10 Condition: S820||Fracture of patella, (10) ICD-10 Condition: S978||Crushing injury of foot, (11) ICD-10 Condition: S822||Fracture of shaft of tibia, (12) ICD-10 Condition: S920||Fracture of calcaneus, (13) ICD-10 Condition: S923||Fracture of metatarsal bone(s), (14) ICD-10 Condition: S929||Unspecified fracture of foot and toe, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
music therapy |
Duration of music therapy from onset of surgery to the end of surgery |
| Comparator Agent |
serum cortisol and serum IgA |
Taking the blood sample 10minutes before spinal anaesthesia,30 minutes and 12 hours after spinal anaesthesia to measure the serum cortisol and serum lgA level. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Physical status classification I and II
2. Patients aged between 18-65years.
3. Patients body mass index between 18-25 kg/m2.
4. Patients posted for lower limb orthopedic surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients who refused to listen music.
2. Having hearing abnormality.
3. History of head and neck surgery
4. Having mental or psychiatric disorders |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of music therapy on anxiety, stress, and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia. |
10 mints before surgery to 12 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate total sedative requirements Bispectral index(BIS) as end point inpatients between two groups.
2.To compare the anxiety levels by using the state-trait anxiety inventory and changes in the hemodynamics parameters in patients between two groups.
3.To compare the stress levels by measuring the serum cortisol and immunoglobulin A level in patients between two groups
|
1.will be taken from after administered of propofol to till end of surgery.
2.10 mints before surgery and 12 hours after surgery.
3.taking the blood sample 10minutes before spinal anaesthesia,30 minutes and 12 hours after spinal anaesthesia to measure the serum cortisol and serum lgA level. |
|
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Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
10/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
INTRODUCTION: Music is capable of evoking strong positive emotions, and elevating the mood of individual . These effects can potentially be used in clinical settings, where negative emotions such as pain often reduce an individual’s subjective well-being. Music has been reported to reduce stress before, during, and after medical procedures including surgery, angiography, and colonoscopy . Correspondingly, some studies suggest that listening to music reduces cortisol levels before, during and after such procedures . In relation to the lower stress levels of patients listening to music, many studies reported that sedative requirements are also reduced in patients undergoing surgery under regional anesthesia combined with sedation . Similar effects have been reported for sedated patients treated in intensive care units. The stress- and pain-reducing effects of music are presumably due to its capability to engage perceptual, emotional, and cognitive processes that (a) interfere with the perception of the noise of the operating theater, (b) consume attentional resources, and (c) evoke feelings of pleasure which interact with pain and unpleasant affects related to the surgical procedure . Cortisol (a corticosteroid hormone that is crucial for glucose metabolism, inflammation suppression, and stress adaptation) is the biochemical that has been investigated most frequently with regard to music. In addition to such hormonal effects, stress levels also affect immune system activity; one of these effects is a transient increase of immunoglobulin A (IgA) in response to an increase in HPA axis activity . Effects of music on serum IgA concentrations were only investigated under general anesthesia, and statistically not significant. Nevertheless, some non-clinical studies suggest effects of music listening on salivary IgA concentrations in awake, healthy individuals . In the present aim of study is to compare the effect of music therapy on anxiety, stress, and sedative requirements in patients undergoing lower limb orthopedics surgery under spinal anaesthesia.
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