NCT02827292

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

May 5, 2016

Last Update Submit

January 17, 2018

Conditions

Laparoscopy

Keywords

musicinflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in Highly sensitive C-reactive protein (HS-CRP)

    Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively

  • Change in Tumor necrosis factor -α (TNF-α)

    Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively

  • Change in CD-3+ (T cells)

    Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively

  • Change in CD-3+/CD-4+ ratio

    Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively

  • Change in CD-3+/CD-8+ ratio

    Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively

  • +3 more secondary outcomes

Study Arms (2)

Laparoscopic Surgery without music

EXPERIMENTAL

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 musicProcedure: Laparoscopic Surgery

Laparoscopic Surgery with music

EXPERIMENTAL

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.

Other: musicProcedure: Laparoscopic Surgery

Interventions

musicOTHER

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.

Laparoscopic Surgery with music
No musicOTHER

Silent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation.

Laparoscopic Surgery without music
Laparoscopic SurgeryPROCEDURE

Patients will undergo Laparoscopic Surgery as per the set protocol

Laparoscopic Surgery with musicLaparoscopic Surgery without music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 to the use of standard music during surgery.
  • Ability to maintain \& communicate a PRO diary.
  • Ability to communicate via telephone or email or text message (SMS).
  • Fitness for general anaesthesia (ASA grade-I and ASA grade-II)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Brij Bushan Agarwal

Delhi, 110058, India

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Music TherapyLaparoscopy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Brij Bhushan Agarwal, MS

CONTACT

+91-9810124256endosurgeon@gmail.com

Neeraj Dhamija, DNB

CONTACT

+91-9811377332neerajdhamija@icloud.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chairman, Department of Laparoscopic and General Surgery

Study Record Dates

First Submitted

May 5, 2016

First Posted

July 11, 2016

Study Start

October 31, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

IN(1)