Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05981924
• Other study ID #: A2023-003
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

• Life expectancy greater than 12 months

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.

Related Conditions & MeSH terms

• Analgesia
• Lung Cancer

Intervention

Other:
• Perioperative Music Therapy
Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Hao Long	Sun Yat-sen University Department of Psychology, Sun Yat-sen University School of Art

Country where clinical trial is conducted

China, 

References & Publications (2)

Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17. — View Citation

Zhou W, Ye C, Wang H, Mao Y, Zhang W, Liu A, Yang CL, Li T, Hayashi L, Zhao W, Chen L, Liu Y, Tao W, Zhang Z. Sound induces analgesia through corticothalamic circuits. Science. 2022 Jul 8;377(6602):198-204. doi: 10.1126/science.abn4663. Epub 2022 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total dose of oxycodone within 72 hours after surgery	The total dose of oxycodone within 72 hours after surgery	72 hours after surgery
Secondary	The VSA-A Score	The Visual Analogue Scale-Anxiety Score at different observation point	1 day before surgery, 1 hour before surgery, 24/48/72 hours after surgery
Secondary	The VSA-P Score	The Visual Analogue Scale-Pain Score at different observation point	24/48/72 hours after surgery
Secondary	The incidence rate of analgesic related adverse reaction	The incidence rate of analgesic related adverse reaction within 72 hours after surgery	72 hours after surgery
Secondary	The usage of extra analgesics after surgery	The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine	72 hours after surgery
Secondary	The kind and usage of anesthetics for anesthesia induction and maintenance	The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium	During the surgery