Effect of Preoperative Music on Sterile Inflammation Induced by Laparoscopic Surgery

NCT03429478 | Completed DMC

• 1 other identifier: EC/10/17/1281
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Surgery induced sterile inflammation leaves behind a biomolecular footprint measurable by various pro-inflammatory markers e.g. IL-6, CD(Cluster of differentiation)19B, HsCRP(High-sensitivity CRP) etc. Music is a non-pharmacological means in attenuating this inflammatory pathway thereby improving Health related quality of life measurable by improved postoperative convalescence. Correct timing of music application is a lacuna in the knowledge. This research aims at evaluating the effect of preoperative music on sterile inflammation induced by index Laparoscopic Surgery (Laparoscopic Cholecystectomy) and its proposed beneficial effects on patient reported outcomes. A total of 50 patients divided into 2 groups (test and control) will be evaluated in this triple blind randomized controlled study aiming at evaluating the biomolecular signatures of sterile inflammatory response and its correlation with improved postoperative convalescence. All the patients will be followed up for a period of 1 month postoperatively to assess for overall improvement in health related quality of life. Collected data will be analysed using updated SPSS software and a p value of less than 0.05 will be taken as statistically significant in support of the measured indices.

Conditions

Music Therapy; Cholecystitis/Cholelithiasis; Inflammatory Response; Surgical Injury

Keywords

Music; Laparoscopic Surgery; Sterile Inflammation

Outcome Measures

Primary Outcomes (4)

• Postoperative Pain (POP)

  Visual Analogue Scale (VAS) will be used to measure the pain on a numeric scale of 0-100 at 6 Hours, Day 1, Day 3, Day 10 and Week 3 postoperatively respectively with a total of 5 readings. Higher values on the VAS will represent a worse outcome. Minimum value on VAS = 0 Maximum value on VAS= 100

  3 weeks

• Postoperative Nausea Vomiting (PONV)

  Visual Analogue Scale (VAS) will be used to measure the PONV on a numeric scale of 0-100 at 6 Hours, Day 1, Day 3, Day 10 and Week 3 postoperatively respectively with a total of 5 readings. Higher values on the VAS will represent a worse outcome. Minimum value on VAS = 0 Maximum value on VAS= 100

  3 weeks

• Postoperative Fatigue (POF)

  Visual Analogue Scale (VAS) will be used to measure the pain on a numeric scale of 0-100 at 6 Hours, Day 1, Day 3, Day 10 and Week 3 postoperatively respectively with a total of 5 readings. Higher values on the VAS will represent a worse outcome. Minimum value on VAS = 0 Maximum value on VAS= 100

  3 weeks

• Gastrointestinal Quality of Life Index (GIQoL)

  Gastrointestinal Quality Of Life Index (GIQoL) 30 Days Min=0 (Best) Max=144 (Worst) GIQoL will be assessed on 30th postoperative day and any difference in the measurement will be assessed for analysis in between the two study arms.

  1 month

Secondary Outcomes (10)

• Liver function test (LFT)

  upto 24 hours after surgical intervention

• Serum amylase

  upto 24 hours after surgical intervention

• Serum lipase

  upto 24 hours after surgical intervention

• Interlukin-6 (IL-6)

  upto 24 hours after surgical intervention

• Tumor Necrosis Factor-alpha (TNF -alpha )

  upto 24 hours after surgical intervention

Study Arms (2)

Music

EXPERIMENTAL

Preoperative application of a Bluetooth enabled headphones with standard music played for atleast 2 hours preoperatively.

Other: Preoperative application of a bluetooth enabled Headphones.

No Music

ACTIVE COMPARATOR

Preoperative application of a Bluetooth enabled headphones with no music played and headphones will just mask the surrounding noise.

Other: Preoperative application of a bluetooth enabled Headphones.

Interventions

Preoperative application of a bluetooth enabled Headphones. OTHER

A Bluetooth enabled Headphones device which is worn overhead and music can be played through it.

Music; No Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age more than 18 years.
• Should be able to understand and sign an informed consent.
• Consent for surgery, anaesthesia and the use of standardized music before surgery. (Appendix I)
• Fitness for General Anesthesia (GA)
• Ability to maintain \& communicate a PRO diary.
• Ability to communicate via telephone or email or SMS or WhatsApp.

You may not qualify if:

• Fitfor GA but higher than ASA Grade I.
• Uncontrolled coagulopathy
• Suspicion of carcinoma gallbladder on USG
• Any suspicion of common bile duct (CBD) stones or pancreatitis.
• Patient using chronic anti-inflammatory drug.
• Concomitant common bile duct (CBD) stone or any CBD intervention/pancreatitis in the preceding 6 weeks.
• Patient on immunosuppressive / cytotoxic/ steroid therapy.
• Documented or known sensitivity to any drug to be used in the study protocol.
• Pregnant or lactating ladies.
• Any concomitant surgery

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Prof. Brij Bushan Agarwal

Delhi, 110058, India

Location

MeSH Terms

Conditions

Cholecystitis; Cholelithiasis; Intraoperative Complications

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Participants will be randomized to be part of the study groups. The Care providers will not be aware of the grouping of the participants as the intervention is done in the pre-operative holding area. All patients will undergo Laparoscopic Cholecystectomy under standard operative and anesthesia protocol. The Investigator (Nurse and the doctor staff) will also be unaware of the grouping of the patients. The recorded data will be analyzed by an individual outcome asser unaware of the grouping or identity of the patient.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman Department of General and Laparoscopic Surgery

Model Details: 50 patients meeting the inclusion criteria will be included in the study after written and informed consent. They will be randomized and divided into 2 groups. Group 1 will be labelled as intervention group (recieving pre-operative music intervention), The group 2 will be labelled as controlled group (Not receiving pre-operative music intervention). Clinico-biochemical, Bio-cellular \& Neurohumoral data evaluation will be done in both the groups.The results will be analyzed using standard SPSS software.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: February 12, 2018
• Study Start: November 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: December 1, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

IN (1)