Postoperative PainNCT04288492
Effect of Biofeedback on Postoperative Pain
A study testing Respiratory biofeedback in people with Postoperative Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Respiratory biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged between 19 and 64 years of age with ASA class I, II who underwent regular laparoscopic cholecystectomy under general anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Respiratory biofeedback
- Keywords
- Respiratory biofeedback, Postpoerative Pain, Preoperative Anxiety
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory biofeedbackBehavioural
Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Respiratory biofeedback |
| general | No intervention | General surgical schedule without control exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes before the anesthesia started.
Secondary outcomes (3)
Total amount of cumulative analgesics
total amount of analgesics are measured for 24 hours after surgery.
Measured: 24 hours after the anesthesia finished.
The rate of Pulmonary complication
medical record is checked after operation
Measured: 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
Measured: 24 hours after the anesthesia finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Jun 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gyeongsang National University Hospital
- Responsible party
- Principal investigator, BON WOOK KOO, Seoul National University Bundang Hospital
- Investigators
- Bon Wook Koo, MD, Study director, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288492
- Sponsor's protocol ID
- biofeedback112233
- Status last verified
- Jan 2024
- First submitted
- 26 Feb 2020
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Exercise Using Preoperative Biofeedback on Postoperative Pain
- ClinicalTrials.gov ID
- NCT04288492
- Acronym / sponsor ID
- biofeedback112233
- Conditions
- Postoperative Pain
- Keywords
- Respiratory biofeedback, Postpoerative Pain, Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Gyeongsang National University Hospital
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofeedback | Experimental | Behavioral: Respiratory biofeedbackRespiratory exercise using biofeedback device(ResCalm) 2-3 times / day for 3 minutes until discharge from hospital, once in recovery room before surgery |
| general | No intervention | –General surgical schedule without control exercise |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients aged between 19 and 64 years of age with ASA class I, II who underwent regular laparoscopic cholecystectomy under general anesthesia.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory biofeedbackRepeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm) | Behavioural | biofeedback |
Primary outcome
Total score of STAI(state-trait anxiety inventory)
Time frame: 20 minutes before the anesthesia started.
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
3 secondary outcomes
Total amount of cumulative analgesics
Time frame: 24 hours after the anesthesia finished.
The rate of Pulmonary complication
Time frame: 24 hours after the anesthesia finished.
The score of pain
Time frame: 24 hours after the anesthesia finished.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon Wook Koo, MD study director
SNUBH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory biofeedback in people with Postoperative Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of STAI(state-trait anxiety inventory) (time frame: 20 minutes before the anesthesia started.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.