Uterus Dysfunction Clinical Trial
Official title:
Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation (TENS): A Randomized Double-blind Placebo-controlled Trial
Aim: To compare the pain-relieving effect of a specific application of TENS vs. placebo TENS
and a control group during unsedated diagnostic office hysteroscopy.
Design: double-blind randomized placebo-controlled trial. Setting: Outpatient setting.
Population: Women who attended annual gynecological check up, and were indicated for
diagnostic office hysteroscopy.
Nowadays, diagnostic hysteroscopy is an easy and economically acceptable technique, that is
being used by the gynecologist to evaluate different pathologies that used to be studied by
other blind techniques. Although most women tolerate it well, the most common cause for
failure during office hysteroscopy is pain. In order to overcome this adversity several
studies have been carried out using different types of pain relievers as local anesthesia,
misoprostol, music, and NSAID to prevent the occurrence of a vagal reaction, but the results
have been contradictory. Other analgesic alternatives that prioritize these three points
should be considered. Transcutaneous electrical nerve stimulation (TENS) has become a very
common electrotherapy as a pain-reliever because of its attributes, namely a noninvasive and
non-pharmacological method based on the delivery of pulsed electrical currents through the
skin, using surface electrodes, effective in many variety of conditions, such as neuropathic
pain, musculoskeletal pain, headache, gynecological and obstetric pain, to treat both
chronic and acute pain, even from visceral organs.
Aim: to compare the pain-relieving effect of a specific application of TENS vs. placebo TENS
and a control group during unsedated diagnostic office hysteroscopy.
Design: double-blind randomized placebo-controlled trial. Setting: Outpatient setting;
Hospital Provincial de Castellon (Spain) and Hospital General de Castellon (Spain).
Population: Women who attended annual gynecological check up, and were indicated for
diagnostic office hysteroscopy
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment