Evaluation of the Effects of Music and Herbal Medicine on Perioperative Anxiety and Pain in Patients Undergoing Retrobulbar Anesthesia for Vitrectomy or Cataract Surgery

The primary objective is to evaluate the effect of music and herbal medicine on perioperative pain in patients undergoing vitrectomy or cataract surgery. This investigation aims to determine the efficacy of these interventions in managing pain levels associated with retrobulbar anaesthesia.

• Investigation of the association between classical music and perioperative anxiety.
• Investigation of the association between herbal medicine and perioperative anxiety.
• Evaluation of the correlation between the speed rate of the retrobulbar injection and pain perception.

The sponsor did not provide the total number of participants. The study population consists of patients undergoing pars plana vitrectomy or cataract surgery on a single eye. Eligible subjects are both male and female individuals aged 18 years or older who are capable of providing informed consent. The primary objectives of the research are:

• To investigate the effect of music on perioperative pain.
• To investigate the effect of herbal medicine on perioperative pain.

This Phase IV clinical trial is designed to investigate the efficacy of music on perioperative anxiety and pain in patients undergoing vitrectomy or cataract surgery. The study involves a comparison between the test product, Nervenruh forte, and the comparator, bromazepam. The primary endpoint is the NRS-P score measured 30 seconds after the administration of a retrobulbar block. Secondary endpoints include assessments using the STAI Questionnaire at admission, as well as NRS-A and NRS-P scores at various intervals before and after the injection and surgical procedure, alongside the duration of the retrobulbar injection. Inclusion criteria require subjects to be over 18 years of age, capable of providing informed consent, and undergoing surgery on a single eye only. The study duration is estimated to span from September 2025 to September 2027.

The experimental treatment consists of Nervenruh forte - Dragees, which is administered in the form of a coated tablet. The active components include lupuli flos dry alcoholic extract, valerian root te with ethanol/ethanol water, and passiflora incarnata dry extract. This medication is administered via an oral route at a dosage of 1 unit.

The comparator treatment is Bromazepam Genericon 3 mg Filmtabletten, which is provided as a film-coated tablet. The active substance is bromazepam. Administration is performed via the oral route at a dosage of 1.5 mg.

The efficacy assessment focuses on evaluating the impact of music and herbal medicine on perioperative pain and anxiety in patients undergoing vitrectomy and/or cataract surgery. The primary endpoint is the NRS-P score measured 30 seconds following the retrobulbar block.

Secondary endpoints include the following parameters:

• STAI Questionnaire administered at admission.
• NRS-P and NRS-A scores measured before the retrobulbar injection.
• NRS-P and NRS-A scores recorded directly after the operation.
• The speed rate and duration of the retrobulbar injection.