Conditions: Anxiety
Keywords: Cranial Electro Stimulation First Eye Cataract Surgery Preoperative sedation Perioperative sedation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 115
Healthy volunteers: no

Brief summary:
Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.

Detailed description:
CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.

Arms:
arm 1: One hour Alpha-Stim intervention with sham midazolam arm 2: Sham Alpha-Stim intervention with real midazolam administration arm 3: No Alpha-Stim and only topical anesthetics

Interventions: intervention 1: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM intervention 2: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY intervention 3: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
Intervention descriptions: intervention 1: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION intervention 2: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION intervention 3: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.

Protocol document: