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OpenTrials
Completed

NCT Number: NCT02647008

Pain Relief During Unsedated Office Hysteroscopy by Applying TENS

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

women who attended annual gynecological check up, and were indicated for diagnostic office hysteroscopy because of different pathologies such as:

  • postmenopausal endometrial thickening >4mm;
  • postmenopausal abnormal uterine bleeding;
  • suspicious endometrial polyp or leiomyoma;
  • infertility study;
  • suspicious endometrial carcinoma;
  • hypermenorrhea

Exclusion criteria

  • age less than 18;
  • previous cervical surgery;
  • neurological deficit;
  • chronic or preprocedural use of opioids or psychoactive drugs;
  • previous experience in TENS;
  • cutaneous damage on the application sites;
  • pacemakers or automatic implanted cardiac defibrillators;
  • refusal to sign the informed consent form;
  • inability to understand informed consent form.

Treatment and study plan

TENS

Device

Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.These small battery powered devices deliver alternating current via cutaneous electrodes positioned near the painful area.

Primary outcomes

  1. Pain, assessed by visual analogue scale (VAS)

    Time frame: 5 minutes after hysteroscopy

Secondary outcomes

  1. Pain assessed by Likert scale.

    Time frame: 5 minutes after hysteroscopy

Other outcomes

  1. Heart Rate

    Time frame: 5 minutes after hysteroscopy

  2. Blood Pleasure

    Time frame: 5 minutes after hysteroscopy

  3. Total procedure time

    Time frame: 5 minutes after hysteroscopy

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation (TENS): A Randomized Double-blind Placebo-controlled Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.