Effects of Music Therapy on Perioperative Anxiety and Pain Management in Lung Surgery: A Randomized, Prospective, Multidisciplinary Trial

Hao Long1 site in 1 country66 target enrollmentAugust 1, 2023

ConditionsAnalgesia Lung Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Analgesia
Sponsor: Hao Long
Enrollment: 66
Locations: 1
Primary Endpoint: The total dose of oxycodone within 48 hours after surgery
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To explore the feasibility and effectiveness of Perioperative Music Therapy Plus Oxycodone in pain management after thoracic surgery, patients will be randomly assigned into two groups. The experimental group will receive perioperative music therapy and the control group will not. We will record and contrast the postoperative oxycodone usage to evaluate the effect of music therapy in relieving the pain. We will also use visual analogue scale, questionnaire and EEG to evaluate patients' anxiety and depression.

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

April 20, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hao Long

Responsible Party

Sponsor Investigator

Principal Investigator

Hao Long

Prof.

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Enhanced CT or PET/CT indicate primary malignant pulmonary nodule;
•The clinical stage belongs to cT1-4N0-2M0 before treatment or ycT1-4N0-2M0 after neoadjuvant treatment (AJCC/TNM 8th Edition);
•Suitable for video-assisted thoracoscopic surgery after evaluated by thoracic surgeon;
•FEV1 \> 1.5L and DLCO \> 60% pred;
•Hearing loss lesser than 35 decibels (dB) in the better hearing ear;
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
•American Society of Anesthesiologists Score of 1 or 2;
•Confirmed eligibility for R0 resection for curative intent by thoracic surgeon assessment;
•Adequate cardiopulmonary function, confirmed to meet the requirement for surgical resection for curative intent;
•Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;

Exclusion Criteria

•Enhanced CT or PET/CT indicate metastatic malignant pulmonary nodule;
•Hearing loss greater than 35 decibels (dB) in the better hearing ear;
•Active autoimmune disease or history of autoimmune disease that may recur; Note: well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid hormone replacement only); well-controlled celiac disease; skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is not expected to recur in the absence of an external trigger.
•History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease;
•Serious infection occurred before grouping, including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; severe chronic or active infection (including pulmonary tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;
•Simultaneous participation in another therapeutic clinical study;
•Pregnant or lactating women, or male and female patients planning to have children during the study;
•Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.

Outcomes

Primary Outcomes

The total dose of oxycodone within 48 hours after surgery

Time Frame: 48 hours after surgery

The total dose of oxycodone within 48 hours after surgery

Secondary Outcomes

The VSA-P Score(From the first day to the third day after surgery)
The incidence rate of analgesic related adverse reaction(48 hours after surgery)
The usage of extra analgesics after surgery(48 hours after surgery)
The quality of life after treatment(The third day after surgery)
The VSA-A Score(From 1 day before surgery to the third day after surgery)
The kind and usage of anesthetics for anesthesia induction and maintenance(During the surgery)
The press times of PCIA pump within 48 hours after surgery(48 hours after surgery)