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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
106
Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)
Bon Wook Koo
Seongnam-si, Gyeonggi-do, South Korea
Total score of STAI(state-trait anxiety inventory)
Preoperative anxiety state is measured using STAI(state-trait anxiety inventory): Total score of 40 questions. Each question is consisted as follows 1: not at all 2: a little 3: somewhat 4: very much so minimal: 40 maximum: 160
Time frame: 20 minutes before the anesthesia started.
Total amount of cumulative analgesics
total amount of analgesics are measured for 24 hours after surgery.
Time frame: 24 hours after the anesthesia finished.
The rate of Pulmonary complication
medical record is checked after operation
Time frame: 24 hours after the anesthesia finished.
The score of pain
VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Time frame: 24 hours after the anesthesia finished.
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