Effect of music therapy in mitigating anxiety and enhancing satisfaction in eldery patients undergoing lower limbs orthopedic surgery under intravertebral anesthesia

Analysis of therapeutic effect of music therapy on patients with lower extremity orthopedic operation under intravertebral anesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN73624669

Enrollment

120

Registered

2024-04-02

Start date

2022-02-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing lower extremity orthopaedic surgery under intravertebral anesthesia Surgery

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

China

Contacts

Public Contactxuanxuan Zhang

gzgk2021@126.com+86 199 6625 1009

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026