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A double blinded randomized control trial – the impact of intraoperative religious chanting vs standard care on post operative pain and recovery following laparoscopic cholecystectomy.

A double blinded randomized control trial – the impact of religious chanting on post operative pain and recovery following laparoscopic cholecystectomy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2024/031
Enrollment
Unknown
Registered
2024-09-25
Start date
2024-10-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Cholecystectomy pain

Interventions

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

Sponsors

Colombo North Centre for Liver Diseases, Faculty of Medicine, University of Kelaniya.
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Assessment of the intensity of post operative pain will be done using the Numeric Rating Scale (NRS) where where 0 = no pain, scores 1 to 3 = mild pain, 4 to 7 = moderate pain and 8 to 10 = severe pain. [Assessed 2,6,12,18,24 and 36 hours following surgery. ]

Secondary

MeasureTime frame
The requirements for the opioid analgesics (S/C morphine 0.1mg/kg) will be recorded as a total dose. [Assessed after 36 hours.] Post operative Nausea and Vomiting will be assessed by the PONV 4 grade scale Post operative Nausea and Vomiting will be assessed by the PONV 4 grade scale: where 1 = no nausea, 2 = mild nausea, 3 = moderate nausea and 4 = severe nausea. [Assessed at 2,6,12,18,24, and 36 hours following surgery. ] Duration of immobilization: time taken to walk to the washroom after surgery [Assessed at 2,6,12,18,24, and 36 hours following surgery. ] Duration of hospital stay [ At the time of discharge] Overall wellbeing - assessed by GCS and general wellbeing [Assessed at 2,6,12,18,24, and 36 hours following surgery.] Intra-operative vitals (blood pressure and pulse rate). [Recorded at every 30 min intervals by the anesthetic team along with the total opioid requirement will be retrieved using anesthetic charts after completion of the surgery. ]

Countries

Sri Lanka

Contacts

Public ContactProf. Rohan Chaminda Siriwardana

Consultant hepatobiliary surgeon

rohansiriwardana@yahoo.com0775544015

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026