Effect of Music on Inflammatory Response During Laparoscopic Surgery

Effects of Peroperative Music on the Biomolecular Inflammatory Response In Laparoscopic Surgery: A Triple Blind Randomized Control Study

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.

Study Overview

• Status: Unknown
• Conditions: Laparoscopy
• Intervention / Treatment: Other: No music; Procedure: Laparoscopic Surgery; Other: music

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110058
    • Recruiting
    • Prof. Brij Bushan Agarwal
    • Contact: Neeraj Dhamija, DNB Surgery; Phone Number: +919811377332; Email: neerajdhamija@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age more than 18 years.
2. Should be able to understand and sign an informed consent.
3. Consent to the use of standard music during surgery.
4. Ability to maintain & communicate a PRO diary.
5. Ability to communicate via telephone or email or text message (SMS).
6. Fitness for general anaesthesia (ASA grade-I and ASA grade-II)

Exclusion Criteria:

1. Surgery for incidental Gall Bladder (GB) disease in patients for other surgeries.
2. Concomitant common bile duct (CBD) stone or any CBD intervention/pancreatitis in the preceding 6 weeks.
3. Non acceptance for the standard music or objection to any unknown music.
4. Suspicion of carcinoma gallbladder on ultrasonography
5. Patients with neuropathic pain/chronic pain needing regular anti-inflammatory drugs.
6. Documented or known sensitivity to any drug to be used in the study protocol.
7. Patient on immunosuppressant/ cytotoxic/ steroid therapy.
8. Pregnant or lactating ladies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laparoscopic Surgery without music; Intervention: Headphones without music (Silent). A headphone will be applied peroperatively but no music will be played. Blood samples to assess the biomolecular inflammatory response and the post operative monitoring will be done as per the protocol.	Other: No music; Silent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation.; Procedure: Laparoscopic Surgery; Patients will undergo Laparoscopic Surgery as per the set protocol
EXPERIMENTAL: Laparoscopic Surgery with music; Intervention: peroperative music via head phones. A headphone will be applied peroperatively and music will be played for the entire duration of the surgical procedure. Blood samples to assess the biomolecular inflammatory response and the post operative monitoring will be done as per the protocol.	Procedure: Laparoscopic Surgery; Patients will undergo Laparoscopic Surgery as per the set protocol; Other: music; A standard music with a standard volume as per the protocol will be played with headphones during the entire duration of the surgery starting from the point of induction to the time of extubation. A proper silent operative room environment will be maintained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interleukin 6 (IL-6)	serum levels of IL-6 will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Highly sensitive C-reactive protein (HS-CRP)	serum levels of HS-CRP will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in Tumor necrosis factor -α (TNF-α)	serum levels of TNF-α will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-3+ (T cells)	serum levels of CD-3+ (T cells) will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-3+/CD-4+ ratio	serum levels of CD-3+/CD-4+ ratio will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-3+/CD-8+ ratio	serum levels of CD-3+/CD-8+ ratio will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-19 (B cells)	serum levels of CD-19 (B cells) will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in Natural Killer Cells-(NK-Cells)	serum levels of NK-Cells will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in Immature platelet factor (IPF)	serum levels of IPF will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Sir Ganga Ram Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2017
• Primary Completion (ANTICIPATED): October 1, 2018
• Study Completion (ANTICIPATED): October 1, 2018

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: music; inflammation
• Other Study ID Numbers: SirGangaRamH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No