AnalgesiaPhase 2NCT05981924
Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery
A Phase 2 study testing Perioperative Music Therapy in people with Analgesia and Lung Cancer, run by Hao Long at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Lung Cancer
- What is being tested?
- Perioperative Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 20 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Music Therapy on Perioperative Anxiety and Pain Management in Lung Surgery: A Randomized, Prospective, Multidisciplinary Trial
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
- Analgesia, Lung Cancer
- Being tested
- Perioperative Music Therapy
- Keywords
- Music Therapy, Anxiety, Quality of Life
- Medical subject headings
- Agnosia, Lung Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Music TherapyOther
Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone with Perioperative Music Therapy | Experimental | Using perioperative music therapy plus oxycodone to manage the postoperative pain Receives: Other: Perioperative Music Therapy |
| Oxycodone without Perioperative Music Therapy | No intervention | Using oxycodone only to manage the postoperative pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of oxycodone within 48 hours after surgery
The total dose of oxycodone within 48 hours after surgery
Measured: 48 hours after surgery
Secondary outcomes (7)
The VSA-A Score
The Visual Analogue Scale-Anxiety Score at different observation point
Measured: 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
Measured: 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
Measured: 48 hours after surgery
The usage of extra analgesics after surgery
The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine
Measured: 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
Measured: During the surgery
The quality of life after treatment
The quality of life assessed by questionnaire on the third day after surgery
Measured: 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
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Aug 2023
- Primary completion20 Jan 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hao Long
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University School of Art, Sun Yat-sen University Department of Psychology
- Responsible party
- Sponsor-investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981924
- Sponsor's protocol ID
- A2023-003
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26282640Zhou 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Therapy on Perioperative Anxiety and Pain Management in Lung Surgery: A Randomized, Prospective, Multidisciplinary Trial
- ClinicalTrials.gov ID
- NCT05981924
- Acronym / sponsor ID
- A2023-003
- Conditions
- Analgesia, Lung Cancer
- Keywords
- Music Therapy, Anxiety, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hao LongUniversity, hospital or other
- Collaborators
- Sun Yat-sen University School of Art, Sun Yat-sen University Department of Psychology
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oxycodone with Perioperative Music Therapy | Experimental | Other: Perioperative Music TherapyUsing perioperative music therapy plus oxycodone to manage the postoperative pain |
| Oxycodone without Perioperative Music Therapy | No intervention | –Using oxycodone only to manage the postoperative pain |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative Music TherapyMusic therapist will play customized music in the perioperative period on the basis of oxycodone analgesia | Other | Oxycodone with Perioperative Music Therapy |
Primary outcome
The total dose of oxycodone within 48 hours after surgery
Time frame: 48 hours after surgery
The total dose of oxycodone within 48 hours after surgery
7 secondary outcomes
The VSA-A Score
Time frame: From 1 day before surgery to the third day after surgery
The VSA-P Score
Time frame: From the first day to the third day after surgery
The incidence rate of analgesic related adverse reaction
Time frame: 48 hours after surgery
The usage of extra analgesics after surgery
Time frame: 48 hours after surgery
The kind and usage of anesthetics for anesthesia induction and maintenance
Time frame: During the surgery
The quality of life after treatment
Time frame: The third day after surgery
The press times of PCIA pump within 48 hours after surgery
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 26282640Palmer 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 publication: PubMed 35857536Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perioperative Music Therapy in people with Analgesia and Lung Cancer, run by Hao Long at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total dose of oxycodone within 48 hours after surgery (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981924, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.