CompletedNCT05981924Updated Jul 17, 2024

Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

A Phase 2 interventional study of Perioperative Music Therapy in Analgesia and Lung Cancer, sponsored by Hao Long. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Hao Long · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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 studied

Analgesia
Lung Cancer

Keywords

Music Therapy
Anxiety
Quality of Life

In context

Lead sponsor

Hao Long is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts 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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 66 participants (actual)

Study arms

Experimental
Oxycodone with Perioperative Music Therapy
Using perioperative music therapy plus oxycodone to manage the postoperative pain
Other: Perioperative Music Therapy
No intervention
Oxycodone without Perioperative Music Therapy
Using oxycodone only to manage the postoperative pain

Interventions

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

What researchers measure

Primary outcomes

The total dose of oxycodone within 48 hours after surgery
The total dose of oxycodone within 48 hours after surgery
Time frame: 48 hours after surgery

Secondary outcomes

The VSA-A Score
The Visual Analogue Scale-Anxiety Score at different observation point
Time frame: From 1 day before surgery to the third day after surgery
The VSA-P Score
The Visual Analogue Scale-Pain Score at different observation point
Time frame: From the first day to the third day after surgery
The incidence rate of analgesic related adverse reaction
The incidence rate of analgesic related adverse reaction within 72 hours after surgery
Time frame: 48 hours after surgery
The usage of extra analgesics after surgery
The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine
Time frame: 48 hours after surgery
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
Time frame: During the surgery
The quality of life after treatment
The quality of life assessed by questionnaire on the third day after surgery
Time frame: The third day after surgery
The press times of PCIA pump within 48 hours after surgery
The press times of PCIA pump within 48 hours after surgery
Time frame: 48 hours after surgery

Other outcomes

Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment
Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment
Time frame: 1 hour before surgery
Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment
Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment
Time frame: 1 hour before surgery

Study locations

1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000, China

References and documents

Publications

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. PubMed 26282640 ↗
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. PubMed 35857536 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05981924
Lead sponsor: Hao Long
Collaborators: Sun Yat-sen University School of Art, Sun Yat-sen University Department of Psychology
Responsible party: Hao Long (Prof., Sun Yat-sen University) — Sponsor-investigator
First posted: Aug 8, 2023
Start date: Aug 1, 2023
Primary completion: Jan 20, 2024
Completion: Apr 20, 2024
Last update: Jul 17, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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