Postoperative PainNCT05540691
Effect of Noise Blocking During General Anesthesia on Postoperative Pain
A study testing Wear noise-cancelling earphones in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
To investigate the effect of noise blocking during general anesthesia on postoperative pain in patients undergoing laparoscopic abdominal surgery. The aim of this study was to determine whether noise blocking can reduce postoperative pain, analgesic use, and its possible effects on intraoperative electrocorticogram. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Wear noise-cancelling earphones
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2022to 28 Feb 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA Classification ⅰ-ⅲ
- Patients undergoing elective laparoscopic abdominal surgery under general anesthesia
- Voluntarily accept PCIA and signed informed consent
Who cannot join
- Patients with previous severe disease
- Patients with hearing abnormalities
- Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
- Patients with chronic preoperative pain and/or long-term analgesic use
- Patients who could not cooperate with the study for any reason
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: Effect of Noise Blocking During General Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Abdominal Surgery
To investigate the effect of noise blocking during general anesthesia on postoperative pain in patients undergoing laparoscopic abdominal surgery. The aim of this study was to determine whether noise blocking can reduce postoperative pain, analgesic use, and its possible effects on intraoperative electrocorticogram.
- Conditions
- Postoperative Pain
- Being tested
- Wear noise-cancelling earphones
- Keywords
- noise blocking, Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wear noise-cancelling earphonesDevice
Intervention of wearing noise-canceling earphones after general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Intraoperative intervention with noise-canceling earphones was performed to isolate the noise Receives: Device: Wear noise-cancelling earphones |
| group 2 | No intervention | After general anesthesia, the intervention of wearing noise-canceling earphones was not given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain score (NRS score) at 0-24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From ending of the surgery to 24 hours postoperatively
Pain score (NRS score) at 0-6 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From ending of the surgery to 6 hours postoperatively
Pain score (NRS score) at 6-12 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From 6 hours postoperatively to 12 hours postoperatively
Pain score (NRS score) at 12-24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Measured: From 12 hours postoperatively to 24 hours postoperatively
Secondary outcomes (2)
Patient controlled analgesia pump analgesic consumption
Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump
Measured: From the time when the surgery was completed until to 24 hours after surgery
Postoperative hyperalgesia after surgery
Postoperative hyperalgesia was measured by the ratio of pressure pain threshold at time when discharged from postanesthesia care unit compare to before surgery
Measured: from the 30 minutes before the surgery until to 30 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start8 Oct 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang He, doctor, Study chair, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540691
- Sponsor's protocol ID
- Noise blocking and pain
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Noise Blocking During General Anesthesia on Postoperative Pain in Patients Undergoing Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05540691
- Acronym / sponsor ID
- Noise blocking and pain
- Conditions
- Postoperative Pain
- Keywords
- noise blocking, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 15 Sep 2022 (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.
To investigate the effect of noise blocking during general anesthesia on postoperative pain in patients undergoing laparoscopic abdominal surgery. The aim of this study was to determine whether noise blocking can reduce postoperative pain, analgesic use, and its possible effects on intraoperative electrocorticogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Device: Wear noise-cancelling earphonesIntraoperative intervention with noise-canceling earphones was performed to isolate the noise |
| group 2 | No intervention | –After general anesthesia, the intervention of wearing noise-canceling earphones was not given |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Classification ⅰ-ⅲ
- Patients undergoing elective laparoscopic abdominal surgery under general anesthesia
- Voluntarily accept PCIA and signed informed consent
Key exclusion criteria (5 listed)
- Patients with previous severe disease
- Patients with hearing abnormalities
- Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
- Patients with chronic preoperative pain and/or long-term analgesic use
- Patients who could not cooperate with the study for any reason
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 |
|---|---|---|
| Wear noise-cancelling earphonesIntervention of wearing noise-canceling earphones after general anesthesia | Device | group 1 |
Primary outcome
Maximum pain score (NRS score) at 0-24 hours postoperatively
Time frame: From ending of the surgery to 24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS score) at 0-6 hours postoperatively
Time frame: From ending of the surgery to 6 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS score) at 6-12 hours postoperatively
Time frame: From 6 hours postoperatively to 12 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS score) at 12-24 hours postoperatively
Time frame: From 12 hours postoperatively to 24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
2 secondary outcomes
Patient controlled analgesia pump analgesic consumption
Time frame: From the time when the surgery was completed until to 24 hours after surgery
Postoperative hyperalgesia after surgery
Time frame: from the 30 minutes before the surgery until to 30 minutes after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email
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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.
Huang He, doctor study chair
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wear noise-cancelling earphones in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 29 Mar 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum pain score (NRS score) at 0-24 hours postoperatively (time frame: From ending of the surgery to 24 hours postoperatively). The study lists 4 primary outcomes in all. 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 29 Mar 2023.