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
Secondary identifying numbers 20220201
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Mr xuanxuan Zhang
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 logoORCID ID 0009-0003-1324-9745
Phone +86 199 6625 1009
Email gzgk2021@126.com

Study information

Study designInterventional randomized parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeEfficacy
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleAnalysis of therapeutic effect of music therapy on patients with lower extremity orthopedic operation under intravertebral anesthesia
Study objectivesMusic 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) studiedPatients undergoing lower extremity orthopaedic surgery under intravertebral anesthesia
InterventionA 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 typeMixed
Primary outcome measure1. 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
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/02/2022
Completion date31/10/2023

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit60 Years
Upper age limit83 Years
SexBoth
Target number of participants120
Total final enrolment120
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2022
Date of final enrolment30/09/2023

Locations

Countries of recruitment

  • China

Study participating centre

Department of Orthopedics, PLA General Hospital
The General Hospital of the People's Liberation Army of the Southern Theater, No. 111, Liuhua Road, Yuexiu District
Guangzhou
510010
China

Sponsor information

PLA General Hospital, Southern Theater Command
Hospital/treatment centre

Department of Orthopedics, The General Hospital of the People's Liberation Army of the Southern Theater, No. 111, Liuhua Road, Yuexiu District
Guangzhou
510010
China

Phone +86 20-88686256
Email chengfudeng2020@163.com

Funders

Funder type

Hospital/treatment centre

Department of Orthopedics, PLA General Hospital

No information available

Results and Publications

Intention to publish date01/06/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe 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

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.