Effect of Biofeedback on Postoperative Pain

Status Active, not recruiting

Clinical Trial Summary

This study is a multi-center, randomized, controlled, double-blinded, and parallel design study. A total of 106 patients were decided to be recruited considering a 10% dropout rate. Patients are randomizes to perform or not respiratory exercises using biofeedback device(ResCalm). The randomization numbers are generated using a computer-generated randomization code and are sealed in the opaque envelope until they are handed over to anesthesiologist in charge of patient management. Record patient preoperative t anxiety, postoperative pain, and pain medication use. Patient aged 19-64 yr, ASA class 1 or 2, and are scheduled for elective laparoscopic cholecystectomy are included. Patients who were unable to perform self breathing at regular intervals were excluded.

Clinical Trial Description

1. Assignment of experimental groups Group A: Respiratory exercise using respiratory biofeedback device(ResCalm) is applied 2-3 times / day for 3 minutes until discharge from hospital and once in the recovery room before surgery. Group B: General surgery schedule without control exercise. All patients measure STAI(state trait anxiety inventory) at the operating room entrance on the day of surgery. 2. anesthesia methods Intravenous anesthesia is performed using the target injection concentration control method. As an anesthetic, propofol / remifentanil / rocuronium is used. The artificial ventilation method is a pressure-controlled ventilation method, which maintains an appropriate pressure and performs anesthesia. 3. postoperative care After anesthesia, the patient wakes up and transfers to the recovery room to encourage self-breathing exercise. After entering the recovery room, the patient's vital signs (average blood pressure, heart rate, oxygen saturation) and analgesic use are checked immediately before leaving. The investigators check for the presence of pulmonary complications, visual analog scale (VAS), analgesic use, and hospital patient satisfaction for 24 hours after surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04288492
Study type	Interventional
Source	Seoul National University Bundang Hospital
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 1, 2021
Completion date	July 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.