LaparoscopyNCT02827292
Effect of Music on Inflammatory Response During Laparoscopic Surgery
A study testing music, No music and Laparoscopic Surgery in people with Laparoscopy, run by Sir Ganga Ram Hospital at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopy
- What is being tested?
- music, No music and Laparoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 31 Oct 2017to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Prof. Brij Bushan Agarwal
Delhi, 110058
Neeraj Dhamija, DNB Surgery, +919811377332, neerajdhamija@icloud.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Laparoscopy
- Being tested
- music, No music, Laparoscopic Surgery
- Keywords
- music, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 SurgeryProcedure or surgery
Patients will undergo Laparoscopic Surgery as per the set protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No music; Procedure: 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. Receives: Other: music; Procedure: Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start31 Oct 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PROF. BRIJ B AGARWAL, Sir Ganga Ram Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827292
- Sponsor's protocol ID
- SirGangaRamH
- Status last verified
- Jan 2018
- First submitted
- 5 May 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peroperative Music on the Biomolecular Inflammatory Response In Laparoscopic Surgery: A Triple Blind Randomized Control Study
- ClinicalTrials.gov ID
- NCT02827292
- Acronym / sponsor ID
- SirGangaRamH
- Conditions
- Laparoscopy
- Keywords
- music, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery without music | Experimental | Other: No music, Procedure: Laparoscopic SurgeryIntervention: 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. |
| Laparoscopic Surgery with music | Experimental | Other: music, Procedure: Laparoscopic SurgeryIntervention: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musicA 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. | Other | Laparoscopic Surgery with music |
| No musicSilent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation. | Other | Laparoscopic Surgery without music |
| Laparoscopic SurgeryPatients will undergo Laparoscopic Surgery as per the set protocol | Procedure or surgery | Laparoscopic Surgery with music, Laparoscopic Surgery without music |
Primary outcome
Change in Interleukin 6 (IL-6)
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
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
8 secondary outcomes
Change in Highly sensitive C-reactive protein (HS-CRP)
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in Tumor necrosis factor -α (TNF-α)
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-3+ (T cells)
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-3+/CD-4+ ratio
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-3+/CD-8+ ratio
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in CD-19 (B cells)
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in Natural Killer Cells-(NK-Cells)
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Change in Immature platelet factor (IPF)
Time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music, No music and Laparoscopic Surgery in people with Laparoscopy, run by Sir Ganga Ram Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brij Bhushan Agarwal, MS (+91-9810124256, endosurgeon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interleukin 6 (IL-6) (time frame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.