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Effect of Biofeedback on Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Respiratory biofeedback
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Respiratory biofeedback, Postpoerative Pain, Preoperative Anxiety

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    biofeedback

    general

    Arm Description

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

    General surgical schedule without control exercise

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Total amount of cumulative analgesics
    total amount of analgesics are measured for 24 hours after surgery.
    The rate of Pulmonary complication
    medical record is checked after operation
    The score of pain
    VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain

    Full Information

    First Posted
    February 26, 2020
    Last Updated
    April 23, 2021
    Sponsor
    Seoul National University Bundang Hospital
    Collaborators
    Gyeongsang National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04288492
    Brief Title
    Effect of Biofeedback on Postoperative Pain
    Official Title
    The Effect of Respiratory Exercise Using Preoperative Biofeedback on Postoperative Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    December 2, 2021 (Anticipated)
    Study Completion Date
    December 3, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital
    Collaborators
    Gyeongsang National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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. 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    Respiratory biofeedback, Postpoerative Pain, Preoperative Anxiety

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    biofeedback
    Arm Type
    Experimental
    Arm Description
    Respiratory exercise using biofeedback device(ResCalm) 2-3 times / day for 3 minutes until discharge from hospital, once in recovery room before surgery
    Arm Title
    general
    Arm Type
    No Intervention
    Arm Description
    General surgical schedule without control exercise
    Intervention Type
    Behavioral
    Intervention Name(s)
    Respiratory biofeedback
    Intervention Description
    Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)
    Primary Outcome Measure Information:
    Title
    Total score of STAI(state-trait anxiety inventory)
    Description
    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
    Time Frame
    20 minutes before the anesthesia started.
    Secondary Outcome Measure Information:
    Title
    Total amount of cumulative analgesics
    Description
    total amount of analgesics are measured for 24 hours after surgery.
    Time Frame
    24 hours after the anesthesia finished.
    Title
    The rate of Pulmonary complication
    Description
    medical record is checked after operation
    Time Frame
    24 hours after the anesthesia finished.
    Title
    The score of pain
    Description
    VAS(visual analog scale) measurement for 24 hours after surgery(0-10) 0: no pain 10: severe pain
    Time Frame
    24 hours after the anesthesia finished.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bon Wook Koo, MD
    Phone
    82-31-787-7504
    Email
    tendong2@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bon Wook Koo, MD
    Organizational Affiliation
    SNUBH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Biofeedback on Postoperative Pain

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