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Effect of Noise Isolation on the Incidence of Moderate to Severe Postoperative Pain

Effect of Noise Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06316440
Enrollment
304
Registered
2024-03-18
Start date
2024-03-12
Completion date
2025-06-30
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

noise Isolation, major abdominal surgery, postoperative Pain

Brief 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 use.

Interventions

Intervention of wearing noise-canceling earphones after general anesthesia

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Shapingba People's Hospital of Chongqing University
CollaboratorUNKNOWN
The 3rd. Affiliated Hospital of Chongqing Medical University
CollaboratorUNKNOWN
Chongqing Hechuan District People's Hospital
CollaboratorUNKNOWN
Chongqing Qijiang District People's Hospital
CollaboratorUNKNOWN
ChongGang General Hospital
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Patients were randomly divided into intervention group(noise blocking) and control group(No noise blocking)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of moderate to severe postoperative painFrom ending of the surgery to 24 hours postoperativelyModerate 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)

Secondary

MeasureTime frameDescription
Patient controlled analgesia pump analgesic consumptionFrom the time when the surgery was completed until to 24 hours after surgeryAnalgesic requirements was assessed by recording the volume of patient controlled analgesia pump
The incidence of additional analgesic requirementsFrom the time when the surgery was completed until to 48 hours after surgerythe percentage of patients who received additional analgesic out of the total number of patients in the group
Maximum pain score (NRS score) at 0-48 hours postoperativelyFrom ending of the surgery to 48 hours postoperativelyNRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
The incidence of moderate to severe postoperative painFrom ending of the surgery to 48 hours postoperativelyModerate 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)
Accumulative postoperative pain NRSFrom ending of the surgery to 48 hours postoperativelyAccumulative 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

Countries

China

Contacts

STUDY_CHAIRGuangyou Duan, Doctor

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026