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

NCT06316440 | Completed DMC

• 1 other identifier: noise and postoperative pain
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

noise Isolation; major abdominal surgery; postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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)

  From ending of the surgery to 24 hours postoperatively

Secondary Outcomes (6)

• Patient controlled analgesia pump analgesic consumption

  From the time when the surgery was completed until to 24 hours after surgery

• Patient controlled analgesia pump analgesic consumption

  From the time when the surgery was completed until to 48 hours after surgery

• The incidence of additional analgesic requirements

  From the time when the surgery was completed until to 48 hours after surgery

• Maximum pain score (NRS score) at 0-48 hours postoperatively

  From ending of the surgery to 48 hours postoperatively

• The incidence of moderate to severe postoperative pain

  From ending of the surgery to 48 hours postoperatively

Other Outcomes (4)

• Pain score (NRS score) at 0-6 hours postoperatively

  From ending of the surgery to 6 hours postoperatively

• Pain score (NRS score) at 6-12 hours postoperatively

  From ending of the surgery to 12 hours postoperatively

• Pain score (NRS score) at 12-24 hours postoperatively

  From 12 hours postoperatively to 24 hours postoperatively

Study Arms (2)

Noise-canceling Group

EXPERIMENTAL

Intraoperative intervention with noise-canceling earphones was performed to isolate the noise

Device: Wear noise-cancelling earphones

Control Group

NO INTERVENTION

After general anesthesia, the intervention of wearing noise-canceling earphones was not given

Interventions

Wear noise-cancelling earphones DEVICE

Intervention of wearing noise-canceling earphones after general anesthesia

Noise-canceling Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing Qijiang District People's Hospital: collaborator
• The Second Affiliated Hospital of Chongqing Medical University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• ChongGang General Hospital: collaborator
• Shapingba People's Hospital of Chongqing University: collaborator
• The 3rd. Affiliated Hospital of Chongqing Medical University: collaborator
• Chongqing Hechuan District People's Hospital: collaborator

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Guangyou Duan, Doctor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: March 12, 2024
• Primary Completion: May 10, 2025
• Study Completion: June 30, 2025
• Last Updated: March 11, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Five years after the study

Locations

CN (1)