NCT05981924CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 31 Jul 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 20 Jan 2024
- Lead sponsor
- Hao Long
- Diseases
- Lung cancer
- NCT number
- NCT05981924
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 66
- From 1 Aug 2023 to the primary completion date, 20 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Enhanced CT or PET/CT indicate metastatic malignant pulmonary nodule;
- 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;
- Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.
Other
- Hearing loss greater than 35 decibels (dB) in the better hearing ear;
- Simultaneous participation in another therapeutic clinical study;
- Pregnant or lactating women, or male and female patients planning to have children during the study;
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.