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Effect of Biofeedback on Postoperative Pain

NCT04288492 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-01-10

No results posted yet for this study

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

Interventions

BEHAVIORAL

Respiratory biofeedback

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

Sponsors & Collaborators

  • Gyeongsang National University Hospital

    collaborator OTHER

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • Bon Wook Koo, MD · SNUBH

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-05-31
Completion
2024-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288492 on ClinicalTrials.gov