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Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery

Sponsor
Hao Long (Other)
Overall Status
Recruiting
CT.gov ID
NCT05981924
Collaborator
Sun Yat-sen University School of Art (Other), Sun Yat-sen University Department of Psychology (Other)
66
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Perioperative Music Therapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oxycodone with Perioperative Music Therapy

Using perioperative music therapy plus oxycodone to manage the postoperative pain

Other: Perioperative Music Therapy
Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia
No Intervention: Oxycodone without Perioperative Music Therapy

Using oxycodone only to manage the postoperative pain

Outcome Measures

Primary Outcome Measures

  1. The total dose of oxycodone within 72 hours after surgery [72 hours after surgery]

    The total dose of oxycodone within 72 hours after surgery

Secondary Outcome Measures

  1. The VSA-A Score [1 day before surgery, 1 hour before surgery, 24/48/72 hours after surgery]

    The Visual Analogue Scale-Anxiety Score at different observation point

  2. The VSA-P Score [24/48/72 hours after surgery]

    The Visual Analogue Scale-Pain Score at different observation point

  3. The incidence rate of analgesic related adverse reaction [72 hours after surgery]

    The incidence rate of analgesic related adverse reaction within 72 hours after surgery

  4. The usage of extra analgesics after surgery [72 hours after surgery]

    The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine

  5. The kind and usage of anesthetics for anesthesia induction and maintenance [During the surgery]

    The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Hao Long
  • Sun Yat-sen University School of Art
  • Sun Yat-sen University Department of Psychology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hao Long, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05981924
Other Study ID Numbers:
  • A2023-003
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hao Long, Prof., Sun Yat-sen University
Music Therapy
Anxiety
Quality of Life
Additional relevant MeSH terms:
Agnosia

Study Results

No Results Posted as of Aug 8, 2023