Is religious chanting effective in reducing post operative pain and hastening recovery following laparoscopic cholecystectomy compared to standard treatment?

Study Setting - Surgical professorial unit in North Colombo Teaching hospital, Ragama. Consecutive, consenting patients who meet inclusion criteria will be sampled. Patient assessment will comprise of a detailed medical history obtained by a medical officer. This will encompass the detection of any co-morbidities and any contraindications for anesthesia. This will also include details of the patient’s religion and his preference of religious chants. All patients will be reviewed by the anesthetic team. Optimization of the essential drugs will be ensured and the patient will be admitted to the ward one day prior to the surgery to undertake preparatory measures.

Pre-operatively the patient will be counselled regarding the trial and informed written consent obtained. Patients will be allocated to two groups using random number tables. The randomization of the patients will be done in the theatre prior to surgery. Patients will be randomized into intervention and control groups by a designated medical officer and the application of headphones will be done by the same medical officer who will not be blinded. He will not take part in the post operative or intra operative care of the patient. The attending anesthetist remains blinded throughout the surgery. The Surgeon who will take decisions with regards to patient management and discharge will not be aware of the patient groups.

Treatment Plan : During laparoscopic cholecystectomy patient is kept supine. General anesthesia and orogastric intubation are offered routinely. All patients will receive 100?g of iv fentanyl, 1-2mg/kg of propofol, 0.6mg/kg of atracurium for intubation and 0.1mg/kg morphine at the induction. Intra venous cefuroxime 1.5mg will be given prophylactically with the induction provided there are no allergies. Patients head end is elevated 10-20 degrees and the table tilted to the left side. Umbilicus is infiltrated with 3-5ml of 0.5% Bupivacaine in all cases. A 10 mm umbilical port is inserted using the open technique. 12mmHg pneumoperitoneum is created.
Muscle relaxation was maintained with IV atracurium and anesthesia maintained with Isoflurane in a 50%:50% combination of oxygen mixed with air. Isoflurane concentration was adjusted to attain a Minimum Alveolar Concentration (MAC) of 1.0 throughout surgery. In the theater standard anesthetic monitoring will be carried out with continuous electrocardiography (ECG), non-invasive blood pressure monitoring (NIBP), pulse oximetry and capnography. Prior to the induction of general anesthesia patients baseline systolic BP, diastolic BP, and pulse rates will be recorded. Before induction of general anesthesia and prior to the skin incision, active noise cancelling headphones (Beyerdynamic DT 990 PRO) connected to a MP3 player (NW-E394 Walkman Digital music player) will be applied to all patients and removed before reversal of muscle relaxants (to ensure patient can comply with instructions from anesthetist).

Recovery - Reversal (neostigmine 0.04mg/kg & atropine 0.02mg/kg), extubation while under anesthesia & recovery (unless contraindicated).

No other music will be played in theaters during the surgery. According to the assigned group, a designated member of the research team (medical officer) chooses either a preselected religious chanting playlist or silence.

The patients assigned to the intervention group will be listening to recordings of religious chants from the onset of general anesthesia (GA) till wound closure. The religious chants include religious chants for each major religion in Sri Lanka (Buddhism, Hinduism, Islam, and Christianity). And then depending on the patient’s religion and preference the selected chant would be played.

For the patients in the control group the headphones will be applied as previously described however a blank file without audio will be played.

In both groups standard laparoscopic procedure previously described will be carried out. The umbilical port will be closed with 1/0 vicryl and the skin sutured with 4/0 subcutaneous Monocryl. All patients will have 2x2 inch plasters placed at port sites. The orogastric tube will be removed immediately and the patient will be transferred to recovery area immediately. Once the patients’ vital parameters are stable, the patient will be shifted to the general ward. Individualized management of each patient is at the discretion of the clinician & any deviation from protocol will be documented.

Post Operative baseline analgesia and drugs- Patients will be transferred to the recovery area and subsequently to the ward where their vitals (blood pressure, pulse rate) will be monitored at stipulated intervals as per the hospital protocol. All patients will receive morphine IV at OT Recovery and paracetamol 1g 6hourly & celecoxib 200mg bd and Ondansetron 8mg at 6 hours after surgery. S/C morphine 0.1mg/kg will be delivered based on patients’ demand. (Pain will be assessed every 6hourly using visual analogue score. If the pain score is more than 5 or if the patient is demanding S/C morphine 0.1mg/kg will be given).

1. All males and females >18 years old who undergo elective laparoscopic cholecystectomy for symptomatic gallstone disease or any other indication.

1. Patients who undergo emergency laparoscopic cholecystectomy.
2. Those who are having conversion from laparoscopy to open cholecystectomy.
3. Duration of surgery more than 3 hours.
4. Patients who have undergone upper abdominal surgeries previously.
5. Patients with known hearing impairment or usage of a hearing aid.
6. Patients using systemic steroids, immunosuppressants or cytotoxic medications.
7. Patients with chronic pain or on regular analgesics.