Effect of music therapy in mitigating anxiety and enhancing satisfaction in eldery patients undergoing lower limbs orthopedic surgery under intravertebral anesthesia
| ISRCTN | ISRCTN73624669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73624669 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 20220201 |
| Sponsor | PLA General Hospital, Southern Theater Command |
| Funder | Department of Orthopedics, PLA General Hospital |
- Submission date
- 26/03/2024
- Registration date
- 02/04/2024
- Last edited
- 30/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This research examines how music therapy can help reduce feelings of worry and improve overall happiness for older patients who are having surgery on their lower limbs while under anesthesia injected into the spine.
Who can participate?
Older patients having surgery on their legs or hips with anesthesia injected into the spine at the Chinese People's Liberation Army General Hospital
What does the study involve?
Patients will be divided into two groups: the control group (with 60 patients) and the music group (also with 60 patients), using a random number table. Patients in the music group will wear headphones and listen to relaxing music via an MP3 player during the surgery. Patients in the control group will wear the same headphones but will not listen to music during the procedure.
What are the possible benefits and risks of participating?
The benefits of taking part are: (1) Getting access to new treatment options. (2) Lessening the financial strain. (3) Learning more about the most recent information concerning your illness. (4) Receiving additional attention from doctors. (5) Reaching high-quality medical care.
The risks of taking part are: Needing to use more energy and the chance that the treatment may not work.
Where is the study run from?
Department of Orthopedics, PLA General Hospital of China
When is the study starting and how long is it expected to run for?
February 2022 to October 2023
Who is funding the study?
Department of Orthopedics, PLA General Hospital of China
Who is the main contact?
Xuanxuan Zhang, gzgk2021@126.com
Contact information
Public, Scientific, Principal investigator
The General Hospital of the People's Liberation Army of the Southern Theater, No. 111, Liuhua Road, Yuexiu District
Guangzhou
510010
China
 ORCID ID |
0009-0003-1324-9745 |
|---|---|
| Phone | +86 199 6625 1009 |
| gzgk2021@126.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized parallel trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Analysis of therapeutic effect of music therapy on patients with lower extremity orthopedic operation under intravertebral anesthesia |
| Study objectives | Music therapy can reduce anxiety and improve satisfaction in patients undergoing lower extremity orthopedic surgery under intravertebral anesthesia |
| Ethics approval(s) |
Approved 23/02/2024, Ethics Committee of the Chinese People's Liberation Army Southern Theater Command General Hospital (Southern War Zone General Hospital, No. 110, Liuhua Road, Yuexiu District, GuangZhou, 510010, China; +86 20-88686180; gzgcp2012@163.com), ref: None |
| Health condition(s) or problem(s) studied | Patients undergoing lower extremity orthopaedic surgery under intravertebral anesthesia |
| Intervention | A total of 120 elderly patients will undergo lower extremity orthopaedic surgery under vertebral anaesthesia in the General Hospital of the Chinese People's Liberation Army. Patients will be divided into a control group (n=60) and a music group (n=60) according to a random number table. Patients in the music group will wear headphones and use MP3 to play relaxing music during the operation. Patients in the control group wore the same headphones but did not play music during the procedure. |
| Intervention type | Mixed |
| Primary outcome measure(s) | 1. Levels of perioperative anxiety measured using The Visual Analog Scale for Anxiety (VAS-A), at pre-operation and post-operation. 2. Hemodynamic Parameters: Heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) measured using continuous monitoring during surgery to provide real-time information on autonomic response using standard medical monitoring equipment, at entry into the operating room (baseline T1), 5 minutes after entering the operating room (T2), before induction of anesthesia (T3), 5 minutes after anesthesia (T4), at the beginning of the operation (T5), 5 minutes after the operation (T6), 30 minutes (T7), 60 minutes of surgery (T8), end of surgery (T9), and one hour after surgery (T10). 3. Salivary Cortisol Levels which is an indicator of stress. Measured using saliva samples collected by the patients themselves using test tubes containing 0.2% trifluoroacetic acid (TFA), followed by centrifugation and measurement using an ELISA (AB154996 Cortisol ELISA kit, Abcam, Cambridge, UK) according to the kit instructions at 15 minutes after waking up on the day of surgery (pre-operation) and the next day (post-operation). 4. Patient Postoperative Satisfaction measured using a standardized homemade questionnaire that includes a question about the satisfaction of the surgery procedure with five answers: A. very satisfied; B. Satisfaction; C. undecided; D. Dissatisfied; E. Very dissatisfied at Post-operation |
| Key secondary outcome measure(s) | There are no secondary outcome measures |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Upper age limit | 83 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Age ≥ 60 years 2. Undergoing lower limbs orthopedic surgery under intravertebral anesthesia 3. Volunteer to participate in this study and sign the informed consent form |
| Key exclusion criteria | 1. Patients with a history of mental illness, hearing impairment, or contraindications to listening to music; 2. Passive position, completely unable to swing anaesthesia position; 3. Coagulation disorders, bleeding tendency and patients taking anticoagulant drugs 4. Patients with shock, circulatory function is unstable 5. Patients with infection of the skin at the puncture site of the corresponding segment 6. Patients with injuries of the spinal column, which cause changes in the position or patients with a history of trauma to the spinal column |
| Date of first enrolment | 01/02/2022 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Guangzhou
510010
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/09/2024 | 30/06/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/06/2025: Publication reference added.
26/03/2024: Trial's existence confirmed by Ethics Committee of the Chinese People's Liberation Army Southern Theater Command General Hospital.
