NCT00928772

Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety

The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety

Interventions

Type	Name	Description
DEVICE	CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM	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
DRUG	MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY	CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
OTHER	NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED	NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-06-26
• Last updated: 2017-04-20
• Results posted: 2017-04-20

Locations

1 site across 1 country: United States