Effect of Biofeedback on Postoperative Pain

NCT ID: NCT04288492

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-07-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

biofeedback

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

Group Type: EXPERIMENTAL

Respiratory biofeedback

Intervention Type: BEHAVIORAL

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

general

General surgical schedule without control exercise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Respiratory biofeedback

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gyeongsang National University Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

BON WOOK KOO

assistnat professosr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bon Wook Koo, MD

Role: STUDY_DIRECTOR

SNUBH

Locations

Bon Wook Koo

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

biofeedback112233

Identifier Type: -

Identifier Source: org_study_id