Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 2:07 PM
Study NCT ID:
NCT02827292
Status:
UNKNOWN
Last Update Posted:
2018-01-18
First Post:
2016-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Music on Inflammatory Response During Laparoscopic Surgery
Sponsor:
Sir Ganga Ram Hospital
Organization:
Study Overview
Official Title:
Effects of Peroperative Music on the Biomolecular Inflammatory Response In Laparoscopic Surgery: A Triple Blind Randomized Control Study
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the effect of per-operative music on the bio-molecular inflammatory response in laparoscopic surgery. Per-operative music intervention will be given to the test group via headphones while the control group will be applied headphones without any music (Silent). The inflammatory stress response will be measured postoperatively at 6 hours and 24 hours postoperatively along with the baseline levels measured preoperatively. The values will be compared between the test and control groups.
Detailed Description:
Laparoscopic surgery (LS) has gained popularity both amongst surgeon as well as patients. The appeal of LS is based on improved patient reported outcomes (PRO). The main PROs like post operative pain, hospital stay and ability to return to activity are better with LS. The improvement in PROs has been attributed to attenuated post operative inflammatory response. The post operative inflammatory response has been studied by the changes in various cytokine pathways. The cytokine response has been shown to be subdued after LS as compare to conventional surgery. This benefit of subdued cytokine response has been shown to translate into better PROs.
Laparoscopic cholecystectomy (LC) has been considered an index LS. It is also an index LS for evaluation of potentially beneficial intervention in LS. The surgical discourse in last two decades has been to achieve clinical equivalence of LS with conventional surgery. The clinical outcomes with LC have stabilized. The current scientific discourse is geared towards improving PROs. A multi dimensional approach including pre-operative optimisation, protocoled anaesthesia technique, and 'systems approach' based surgery and standardised dissection techniques have been recommended.
Peri-operative music has been shown to improve PROs in LC . A recently published meta-analysis has established the benefits of peri-operative music in post operative convalescence. Peri-operative music has been shown to affect the neurohumoral and cyto-immune expressions of various 'cluster of differentiation' (CD) markers, on various cell lines.
Despite the established efficacy of music, there is reluctance amongst surgeon to adopt it routinely. There is no clarity and scientific curiosity about the type of music and the timing of music intervention, for the observed benefits of peri-operative music. The biomolecular basis of the reported benefits, of music in surgical setting has not been studied in an objective manner.
With this background the investigators hypothesized that per-operative music should have measurable bio-molecular footprint in postoperative convalescence use. With this hypothesis the investigators wish to study the per-operative music effects on the PROs, in laparoscopic cholecystectomy with measurable bio-molecular or/and bio-cellular markers.
Laparoscopic cholecystectomy (LC) has been considered an index LS. It is also an index LS for evaluation of potentially beneficial intervention in LS. The surgical discourse in last two decades has been to achieve clinical equivalence of LS with conventional surgery. The clinical outcomes with LC have stabilized. The current scientific discourse is geared towards improving PROs. A multi dimensional approach including pre-operative optimisation, protocoled anaesthesia technique, and 'systems approach' based surgery and standardised dissection techniques have been recommended.
Peri-operative music has been shown to improve PROs in LC . A recently published meta-analysis has established the benefits of peri-operative music in post operative convalescence. Peri-operative music has been shown to affect the neurohumoral and cyto-immune expressions of various 'cluster of differentiation' (CD) markers, on various cell lines.
Despite the established efficacy of music, there is reluctance amongst surgeon to adopt it routinely. There is no clarity and scientific curiosity about the type of music and the timing of music intervention, for the observed benefits of peri-operative music. The biomolecular basis of the reported benefits, of music in surgical setting has not been studied in an objective manner.
With this background the investigators hypothesized that per-operative music should have measurable bio-molecular footprint in postoperative convalescence use. With this hypothesis the investigators wish to study the per-operative music effects on the PROs, in laparoscopic cholecystectomy with measurable bio-molecular or/and bio-cellular markers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: