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
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring Respiratory biofeedback, Postpoerative Pain, Preoperative Anxiety
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
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
NCT ID
NCT04288492
First Posted
February 26, 2020
Last Updated
April 23, 2021
Sponsor
Seoul National University Bundang Hospital
Collaborators
Gyeongsang National University Hospital
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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