Effect of Biofeedback on Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

The Effect of Respiratory Exercise Using Preoperative Biofeedback on Postoperative Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04288492
• Other study ID #: biofeedback112233
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Behavioral:
• Respiratory biofeedback
Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)

Locations

Country	Name	City	State
Korea, Republic of	Bon Wook Koo	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Gyeongsang National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total amount of cumulative analgesics	total amount of analgesics are measured for 24 hours after surgery.	24 hours after the anesthesia finished.
Secondary	The rate of Pulmonary complication	medical record is checked after operation	24 hours after the anesthesia finished.
Secondary	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.