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Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05981924
Enrollment
66
Registered
2023-08-08
Start date
2023-08-01
Completion date
2024-04-20
Last updated
2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Lung Cancer

Keywords

Music Therapy, Anxiety, Quality of Life

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.

Interventions

OTHERPerioperative Music Therapy

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

Sponsors

Sun Yat-sen University School of Art
CollaboratorUNKNOWN
Sun Yat-sen University Department of Psychology
CollaboratorUNKNOWN
Hao Long
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients will be randomly assigned into two groups, the experimental group will receive music therapy and oxycodone for the pain management after thoracic surgery. The control group will only use oxycodone to relief the pain.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The total dose of oxycodone within 48 hours after surgery48 hours after surgeryThe total dose of oxycodone within 48 hours after surgery

Secondary

MeasureTime frameDescription
The VSA-A ScoreFrom 1 day before surgery to the third day after surgeryThe Visual Analogue Scale-Anxiety Score at different observation point
The VSA-P ScoreFrom the first day to the third day after surgeryThe Visual Analogue Scale-Pain Score at different observation point
The incidence rate of analgesic related adverse reaction48 hours after surgeryThe incidence rate of analgesic related adverse reaction within 72 hours after surgery
The usage of extra analgesics after surgery48 hours after surgeryThe usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine
The quality of life after treatmentThe third day after surgeryThe quality of life assessed by questionnaire on the third day after surgery
The press times of PCIA pump within 48 hours after surgery48 hours after surgeryThe press times of PCIA pump within 48 hours after surgery
The kind and usage of anesthetics for anesthesia induction and maintenanceDuring the surgeryThe kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium

Other

MeasureTime frameDescription
Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment1 hour before surgeryChanges of resting beta power of electroencephalography in the central brain areas by preoperative treatment
Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment1 hour before surgeryChanges of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026