Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

NCT ID: NCT05981924

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-04-20

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.

Conditions

Analgesia; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxycodone with Perioperative Music Therapy

Using perioperative music therapy plus oxycodone to manage the postoperative pain

Group Type: EXPERIMENTAL

Perioperative Music Therapy

Intervention Type: OTHER

Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia

Oxycodone without Perioperative Music Therapy

Using oxycodone only to manage the postoperative pain

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Perioperative Music Therapy

Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia

Intervention Type: OTHER

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University School of Art

UNKNOWN

Sponsor Role: collaborator

Sun Yat-sen University Department of Psychology

UNKNOWN

Sponsor Role: collaborator

Hao Long

OTHER

Sponsor Role: lead

Responsible Party

Hao Long

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 26282640 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35857536 (View on PubMed)

Other Identifiers

A2023-003

Identifier Type: -

Identifier Source: org_study_id