Effect of Biofeedback on Postoperative Pain

The Effect of Respiratory Exercise Using Preoperative Biofeedback on Postoperative Pain

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Behavioral: Respiratory biofeedback

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 Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13590
      • Bon Wook Koo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: biofeedback; 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; Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)
No Intervention: general; 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.

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Gyeongsang National University Hospital
• Investigators: Study Director: Bon Wook Koo, MD, SNUBH

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Preoperative Anxiety; Respiratory biofeedback; Postpoerative Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: biofeedback112233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No