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

NCT ID: NCT06316440

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Noise-canceling Group

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

Group Type EXPERIMENTAL

Wear noise-cancelling earphones

Intervention Type DEVICE

Intervention of wearing noise-canceling earphones after general anesthesia

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Wear noise-cancelling earphones

Intervention of wearing noise-canceling earphones after general anesthesia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Shapingba People's Hospital of Chongqing University

UNKNOWN

Sponsor Role collaborator

The 3rd. Affiliated Hospital of Chongqing Medical University

UNKNOWN

Sponsor Role collaborator

Chongqing Hechuan District People's Hospital

UNKNOWN

Sponsor Role collaborator

Chongqing Qijiang District People's Hospital

UNKNOWN

Sponsor Role collaborator

ChongGang General Hospital

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guangyou Duan, Doctor

Role: STUDY_CHAIR

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

Locations

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

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guangyou Duan, Doctor

Role: CONTACT

(+86)18323376014

Facility Contacts

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Guangyou Duan, MD

Role: primary

(+86)18323376014

Other Identifiers

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noise and postoperative pain

Identifier Type: -

Identifier Source: org_study_id

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