Effect of Biofeedback on Postoperative Pain

Not Applicable

Active, not recruiting

• Conditions: Postoperative Pain
• Interventions: Behavioral: Respiratory biofeedback

• Registration Number: NCT04288492
• Lead Sponsor: Seoul National University Bundang Hospital

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

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 Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-28
• Study Start: 2021-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biofeedback	Respiratory biofeedback	Respiratory exercise using biofeedback device(ResCalm) 2-3 times / day for 3 minutes until discharge from hospital, once in recovery room before surgery

Primary Outcome Measures

Name	Time	Method
Total score of STAI(state-trait anxiety inventory)	20 minutes before the anesthesia started.	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

Secondary Outcome Measures

Name	Time	Method
The rate of Pulmonary complication	24 hours after the anesthesia finished.	medical record is checked after operation
The score of pain	24 hours after the anesthesia finished.	VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
Total amount of cumulative analgesics	24 hours after the anesthesia finished.	total amount of analgesics are measured for 24 hours after surgery.

Trial Locations

Locations (1)

Bon Wook Koo; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of