Effect of Music on Inflammatory Response During Laparoscopic Surgery
NCT ID: NCT02827292
Last Updated: 2018-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-10-31
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
No music
Silent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation.
Laparoscopic Surgery
Patients will undergo Laparoscopic Surgery as per the set protocol
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.
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.
Laparoscopic Surgery
Patients will undergo Laparoscopic Surgery as per the set protocol
Interventions
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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.
No music
Silent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation.
Laparoscopic Surgery
Patients will undergo Laparoscopic Surgery as per the set protocol
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Sir Ganga Ram Hospital
OTHER
Responsible Party
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PROF. BRIJ B AGARWAL
Vice Chairman, Department of Laparoscopic and General Surgery
Locations
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Prof. Brij Bushan Agarwal
Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SirGangaRamH
Identifier Type: -
Identifier Source: org_study_id
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