Effect of Biofeedback on Postoperative Pain

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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. 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. 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.

Official Title
-----------------
The Effect of Respiratory Exercise Using Preoperative Biofeedback on Postoperative Pain

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Behavioral: Respiratory biofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients aged between 19 and 64 years of age with ASA class I, II who underwent regular laparoscopic cholecystectomy under general anesthesia. Exclusion Criteria: Seniors 65 years of age or older or minors under 19 years of age ASA (American Society of Anesthesiologists) class ≥ III Difficulties in proper cooperation with diseases such as Alzheimer dementia, cognitive disorders, and psychopathy Patients with respiratory diseases such as Asthma, Pnuemonia Patients with incomplete airway due to pulmonary resection, airway surgery, mouth or nose surgery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: biofeedback<br>Respiratory exercise using biofeedback device(ResCalm) 2-3 times / day for 3 minutes until discharge from hospital, once in recovery room before surgery | Behavioral: Respiratory biofeedback<br>* Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)<br>|
| No Intervention: general<br>General surgical schedule without control exercise | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 20 minutes before the anesthesia started. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of cumulative analgesics | total amount of analgesics are measured for 24 hours after surgery. | 24 hours after the anesthesia finished. | 
| The rate of Pulmonary complication | medical record is checked after operation | 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 | 24 hours after the anesthesia finished. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory biofeedback, Postpoerative Pain, Preoperative Anxiety