Postoperative PainNCT06316440
Effect of Noise Isolation on the Incidence of Moderate to Severe 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 isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic… 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
- 304 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2024to 30 Jun 2025
- 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
- Between the ages of 18 and 70, both male and female.
- American Society of Anesthesiologists Classification 1-3
- Patients undergoing elective major abdominal surgery under general anesthesia(Surgery time ≥ 2h)
- Voluntarily accept patient controlled intravenous analgesia 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 Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery
To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use.
- Conditions
- Postoperative Pain
- Being tested
- Wear noise-cancelling earphones
- Keywords
- noise Isolation, major abdominal surgery, 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 |
|---|---|---|
| Noise-canceling Group | Experimental | Intraoperative intervention with noise-canceling earphones was performed to isolate the noise Receives: Device: Wear noise-cancelling earphones |
| Control Group | 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.
The incidence of moderate to severe postoperative pain
Moderate to severe postoperative pain：NRS score ≥ 4 (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful)
Measured: From ending of the surgery to 24 hours postoperatively
Secondary outcomes (6)
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
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 48 hours after surgery
The incidence of additional analgesic requirements
the percentage of patients who received additional analgesic out of the total number of patients in the group
Measured: From the time when the surgery was completed until to 48 hours after surgery
Maximum pain score (NRS score) at 0-48 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 48 hours postoperatively
The incidence of moderate to severe postoperative pain
Moderate to severe postoperative pain：NRS score ≥ 4 (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful)
Measured: From ending of the surgery to 48 hours postoperatively
Accumulative postoperative pain NRS
Accumulative NRS score (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful) at 6, 12, 24 and 48 hours after surgery
Measured: From ending of the surgery to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start12 Mar 2024
- Primary completion10 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Shapingba People's Hospital of Chongqing University, The 3rd. Affiliated Hospital of Chongqing Medical University, Chongqing Hechuan District People's Hospital, Chongqing Qijiang District People's Hospital, ChongGang General Hospital
- Responsible party
- Sponsor
- Investigators
- Guangyou Duan, Doctor, Study chair, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316440
- Sponsor's protocol ID
- noise and postoperative pain
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 11 Mar 2026
- 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
Publications
Xu F, Chen D, Wang C, Yang Y, Wu Y, You S, Duan G. Effect of noise isolation during general anaesthesia on the incidence of moderate-to-severe pain after major abdominal surgery: multicentre randomized clinical study. BJS Open. 2026 May 12;10(3):zrag035. doi: 10.1093/bjsopen/zrag035.
PubMed 42206821
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Noise Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06316440
- Acronym / sponsor ID
- noise and postoperative pain
- Conditions
- Postoperative Pain
- Keywords
- noise Isolation, major abdominal surgery, postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Shapingba People's Hospital of Chongqing University, The 3rd. Affiliated Hospital of Chongqing Medical University, Chongqing Hechuan District People's Hospital, Chongqing Qijiang District People's Hospital, ChongGang General Hospital
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Mar 2024 (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 isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use.
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 |
|---|---|---|
| Noise-canceling Group | Experimental | Device: Wear noise-cancelling earphonesIntraoperative intervention with noise-canceling earphones was performed to isolate the noise |
| Control Group | 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 (4 listed)
- Between the ages of 18 and 70, both male and female.
- American Society of Anesthesiologists Classification 1-3
- Patients undergoing elective major abdominal surgery under general anesthesia(Surgery time ≥ 2h)
- Voluntarily accept patient controlled intravenous analgesia 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 | Noise-canceling Group |
Primary outcome
The incidence of moderate to severe postoperative pain
Time frame: From ending of the surgery to 24 hours postoperatively
Moderate to severe postoperative pain：NRS score ≥ 4 (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful)
6 secondary outcomes
Patient controlled analgesia pump analgesic consumption
Time frame: From the time when the surgery was completed until to 24 hours after surgery
Patient controlled analgesia pump analgesic consumption
Time frame: From the time when the surgery was completed until to 48 hours after surgery
The incidence of additional analgesic requirements
Time frame: From the time when the surgery was completed until to 48 hours after surgery
Maximum pain score (NRS score) at 0-48 hours postoperatively
Time frame: From ending of the surgery to 48 hours postoperatively
The incidence of moderate to severe postoperative pain
Time frame: From ending of the surgery to 48 hours postoperatively
Accumulative postoperative pain NRS
Time frame: From ending of the surgery to 48 hours postoperatively
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 11 Mar 2026.
- Derived from this study: PubMed 42206821Xu F, Chen D, Wang C, Yang Y, Wu Y, You S, Duan G. Effect of noise isolation during general anaesthesia on the incidence of moderate-to-severe pain after major abdominal surgery: multicentre randomized clinical study. BJS Open. 2026 May 12;10(3):zrag035. doi: 10.1093/bjsopen/zrag035.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Guangyou Duan, 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 4 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 11 Mar 2026. 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?
The incidence of moderate to severe postoperative pain (time frame: From ending of the surgery to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06316440, which also lists 1 linked publication.
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 11 Mar 2026.