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Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery

Primary Purpose

Analgesia, Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Perioperative Music Therapy
Sponsored by
Hao Long
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Music Therapy, Anxiety, Quality of Life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oxycodone with Perioperative Music Therapy

Oxycodone without Perioperative Music Therapy

Arm Description

Using perioperative music therapy plus oxycodone to manage the postoperative pain

Using oxycodone only to manage the postoperative pain

Outcomes

Primary Outcome Measures

The total dose of oxycodone within 72 hours after surgery
The total dose of oxycodone within 72 hours after surgery

Secondary Outcome Measures

The VSA-A Score
The Visual Analogue Scale-Anxiety Score at different observation point
The VSA-P Score
The Visual Analogue Scale-Pain Score at different observation point
The incidence rate of analgesic related adverse reaction
The incidence rate of analgesic related adverse reaction within 72 hours after surgery
The usage of extra analgesics after surgery
The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine
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

Full Information

First Posted
July 31, 2023
Last Updated
August 30, 2023
Sponsor
Hao Long
Collaborators
Sun Yat-sen University School of Art, Sun Yat-sen University Department of Psychology
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1. Study Identification

Unique Protocol Identification Number
NCT05981924
Brief Title
Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery
Official Title
A Phase II Study of Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hao Long
Collaborators
Sun Yat-sen University School of Art, Sun Yat-sen University Department of Psychology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Lung Cancer
Keywords
Music Therapy, Anxiety, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone with Perioperative Music Therapy
Arm Type
Experimental
Arm Description
Using perioperative music therapy plus oxycodone to manage the postoperative pain
Arm Title
Oxycodone without Perioperative Music Therapy
Arm Type
No Intervention
Arm Description
Using oxycodone only to manage the postoperative pain
Intervention Type
Other
Intervention Name(s)
Perioperative Music Therapy
Intervention Description
Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia
Primary Outcome Measure Information:
Title
The total dose of oxycodone within 72 hours after surgery
Description
The total dose of oxycodone within 72 hours after surgery
Time Frame
72 hours after surgery
Secondary Outcome Measure Information:
Title
The VSA-A Score
Description
The Visual Analogue Scale-Anxiety Score at different observation point
Time Frame
1 day before surgery, 1 hour before surgery, 24/48/72 hours after surgery
Title
The VSA-P Score
Description
The Visual Analogue Scale-Pain Score at different observation point
Time Frame
24/48/72 hours after surgery
Title
The incidence rate of analgesic related adverse reaction
Description
The incidence rate of analgesic related adverse reaction within 72 hours after surgery
Time Frame
72 hours after surgery
Title
The usage of extra analgesics after surgery
Description
The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine
Time Frame
72 hours after surgery
Title
The kind and usage of anesthetics for anesthesia induction and maintenance
Description
The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium
Time Frame
During the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Long, MD
Phone
+86-20-87343314
Email
longhao@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Long, MD
Phone
+86-20-87343261
Email
longhao@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26282640
Citation
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.
Results Reference
background
PubMed Identifier
35857536
Citation
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.
Results Reference
result

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Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery

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