In short
Clinical trials are studying TROCKENEXTRAKT AUS PASSIONSBLUMENKRAUT 5-7:1, AUSZUGSMITTEL ETHANOL 60 % (V/V) in patients having eye surgery. The trial aims to look at perioperative anxiety and pain, with a main focus on pain after a retrobulbar block. It includes people undergoing vitrectomy and/or cataract surgery.
Key points
- Clinical trials are studying TROCKENEXTRAKT AUS PASSIONSBLUMENKRAUT 5-7:1, AUSZUGSMITTEL ETHANOL 60 % (V/V) in people having eye surgery. The main focus is perioperative anxiety and pain, especially pain measured 30 seconds after a retrobulbar block. The trial includes patients undergoing vitrectomy and/or cataract surgery. It is listed as Low Intervention and is authorised. The planned enrollment is 240 participants.
Trial overview
The available trial investigates TROCKENEXTRAKT AUS PASSIONSBLUMENKRAUT 5-7:1, AUSZUGSMITTEL ETHANOL 60 % (V/V) in the setting of eye surgery. Its brief summary says the study aims to investigate the effect of music on perioperative pain and the effect of herbal medicine on perioperative pain.
The trial is titled “The effect of music on perioperative anxiety and pain of patients undergoing retrobulbar anaesthesia.” This tells us the research is centered on anxiety and pain around the time of surgery, not on long-term disease treatment.
Who can participate
The study includes patients undergoing vitrectomy and/or cataract surgery. These are eye operations, so the target population is people scheduled for these procedures.
The trial data do not list any other eligibility details, such as age limits or extra medical conditions. Based on the source, the main known group is patients having eye surgery with retrobulbar anaesthesia.
What is being measured
The main endpoint is the NRS-P score 30 seconds after the retrobulbar block. An endpoint is the main result a trial measures to see whether the study question is answered.
NRS-P is a pain rating score, so this trial is checking how much pain patients feel very soon after the block. The trial also looks at perioperative anxiety and pain more broadly, based on the study title and summary.
Study design and status
The study is listed as Interventional and Low Intervention. Interventional means the researchers are testing a planned approach in participants, while Low Intervention suggests a lower-burden study design.
The status is Authorised, and the planned enrollment is 240 participants. Enrollment means the number of people the study aims to include.
Patient terms explained
Perioperative anxiety means worry or nervousness before, during, or after surgery. Perioperative pain means pain linked to the surgery period.
A retrobulbar block is an injection used around the eye to numb it for surgery. The study checks the pain score shortly after this block to understand the immediate patient experience.
Vitrectomy and cataract surgery are eye operations, and both are part of the study population described in the trial record. The source does not provide more detail on outcomes beyond the pain score and the anxiety/pain focus.