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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
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. CONDITION: Patients undergoing lower extremity orthopaedic surgery under intravertebral anesthesia ; Surgery PRIMARY OUTCOME: 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 OUTCOME: There are no secondary outcome measures 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
Epistemonikos ID: cbacfa1fe18999ec44ff6132f08e6ea4670edf7c
First added on: Aug 28, 2024