Study of herbal medicine combination and bromazepam for anxiety and pain in patients having eye surgery with retrobulbar anesthesia

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What is this study about?

This study examines patients who are having eye surgery, specifically vitrectomy or cataract surgery. Vitrectomy is a procedure where the gel-like substance inside the eye is removed, while cataract surgery involves removing the cloudy lens of the eye and replacing it with a clear artificial one. These surgeries require a type of numbing injection called retrobulbar anaesthesia, which is given behind the eyeball to block pain during the operation. The study will use two different treatments: one is a herbal medicine tablet called Nervenruh forte that contains plant extracts from hops flower, valerian root, and passionflower, and the other is a medication called Bromazepam. Both of these medications are intended to help reduce anxiety and discomfort. The purpose of the study is to investigate whether listening to music and taking herbal medicine can reduce pain and anxiety during the time around the surgery.

During the study, patients will receive one of the treatments before their eye surgery. The study will measure pain and anxiety levels at different times: when patients first arrive, before the numbing injection is given, right after the injection is given, and immediately after the surgery is completed. Pain will be measured using a scale where patients rate their pain level, and anxiety will be measured using questionnaires that ask about feelings of nervousness or worry. The study will also record how long it takes to give the numbing injection behind the eye.

Patients participating in this study will be adults over 18 years old who need surgery on one eye only. The treatments being tested are taken by mouth in tablet form. The study aims to understand whether these approaches can make the surgical experience less painful and less stressful for patients undergoing this type of eye surgery with retrobulbar anaesthesia.

1 Admission and initial assessment

Upon joining the study, you will complete the STAI Questionnaire at admission. This questionnaire measures your level of anxiety at that moment.

This assessment will be conducted before your eye surgery procedure begins.

2 Assessment before retrobulbar injection

Before receiving the retrobulbar injection, which is a type of anesthesia administered behind the eye, you will be asked to rate your pain and anxiety levels.

The pain level will be measured using the NRS-P score, which is a numerical rating scale for pain where you indicate how much pain you are experiencing.

The anxiety level will be measured using the NRS-A score, which is a numerical rating scale for anxiety where you indicate how anxious you are feeling.

3 Retrobulbar injection procedure

You will receive a retrobulbar injection, which is an anesthesia injection given behind your eye to numb the area for surgery.

The duration and speed of this injection will be recorded as part of the study measurements.

4 Assessment after retrobulbar injection

Thirty seconds after receiving the retrobulbar injection, you will be asked to rate your pain level using the NRS-P score.

This measurement is the main focus of the study.

5 Eye surgery procedure

Your scheduled eye surgery will be performed. This may be either vitrectomy, which is a procedure to remove the gel-like substance inside the eye, or cataract surgery, which is a procedure to remove the clouded lens of the eye.

The surgery will be performed on one eye only.

6 Assessment immediately after surgery

Directly after the operation is completed, you will be asked to rate your pain level using the NRS-P score.

You will also be asked to rate your anxiety level using the NRS-A score.

These final assessments will complete your participation in the study measurements.

Who Can Join the Study?

You must be 18 years of age or older
You must be able to understand the study information and give your informed consent, which means you can agree to participate after receiving clear information about the study
You must need eye surgery called pars plana vitrectomy, which is a procedure to remove the gel-like substance inside your eye, or cataract surgery, which is a procedure to remove the cloudy lens in your eye and replace it with a clear artificial lens
The surgery must be needed on only one eye

Who Cannot Join the Study?

The study does not list specific reasons that would prevent you from participating
However, you should discuss with your doctor if you have any concerns about taking part in this research
General factors that might affect your ability to participate could include your overall health condition and any medications you are currently taking
If you have hearing problems that would prevent you from listening to music during the procedure, this may affect your participation
If you have known allergies or bad reactions to herbal medicines (natural plant-based treatments), you should inform your doctor

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Graz	Graz	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Music therapy is a non-medication treatment that involves listening to music before, during, or after a medical procedure. In this trial, music is being studied to see if it can help reduce feelings of anxiety and pain that patients may experience during eye surgery with retrobulbar anaesthesia, which is a type of numbing injection given behind the eye.

Herbal medicine refers to plant-based treatments that are being tested in this study. The trial is examining whether herbal medicine can help reduce pain that patients experience around the time of their eye surgery procedure.

Investigated diseases:

Cataract

Cataract – Cataract is a condition where the normally clear lens of the eye becomes cloudy, leading to decreased vision. This cloudiness develops gradually over time as proteins in the lens break down and clump together. People with cataracts may experience blurry or dim vision, increased sensitivity to glare, and difficulty seeing at night. The condition can affect one or both eyes, though it does not spread from one eye to the other. Colors may appear faded or yellowed as the cataract progresses. Without intervention, the cloudiness continues to worsen, making daily activities increasingly difficult.

Vitreous Detachment – Vitreous detachment occurs when the gel-like substance filling the eye, called the vitreous, separates from the retina at the back of the eye. This is a common age-related change that happens as the vitreous naturally shrinks and becomes more liquid over time. People may notice floaters, which appear as spots or cobwebs in their vision, or brief flashes of light. The condition typically begins in one eye and may later occur in the other eye. Most cases happen gradually and are a normal part of aging. The separation usually progresses until the vitreous is completely detached from the retina.

Trial ID:

2024-520132-15-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of herbal medicine combination and bromazepam for anxiety and pain in patients having eye surgery with retrobulbar anesthesia

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