Effect of Biofeedback on Postoperative Pain

NCT04288492 | Unknown DMC

• 1 other identifier: biofeedback112233
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Respiratory biofeedback; Postpoerative Pain; Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total amount of cumulative analgesics

  24 hours after the anesthesia finished.

• The rate of Pulmonary complication

  24 hours after the anesthesia finished.

• The score of pain

  24 hours after the anesthesia finished.

Study Arms (2)

biofeedback

EXPERIMENTAL

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

general

NO INTERVENTION

General surgical schedule without control exercise

Interventions

Respiratory biofeedback BEHAVIORAL

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

biofeedback

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged between 19 and 64 years of age with ASA class I, II who underwent regular laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Gyeongsang National University Hospital: collaborator

Study Sites (1)

Bon Wook Koo

Seongnam-si, Gyeonggi-do, 13590, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bon Wook Koo, MD

  SNUBH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistnat professosr

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: June 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)