Pain Relief During Unsedated Office Hysteroscopy by Applying TENS

September 11, 2016 updated by: Juan F. Lisón Párraga, Dr, Cardenal Herrera University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Valencia
      • Moncada, Valencia, Spain, 46113
        • Universidad CEU Cardenal Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACTIVE TENS
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.
Placebo Comparator: PLACEBO
INACTIVE TENS
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.
No Intervention: CONTROL
NO TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain, assessed by visual analogue scale (VAS)
Time Frame: 5 minutes after hysteroscopy
5 minutes after hysteroscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain assessed by Likert scale.
Time Frame: 5 minutes after hysteroscopy
5 minutes after hysteroscopy

Other Outcome Measures

Outcome Measure
Time Frame
Heart Rate
Time Frame: 5 minutes after hysteroscopy
5 minutes after hysteroscopy
Blood Pleasure
Time Frame: 5 minutes after hysteroscopy
5 minutes after hysteroscopy
Total procedure time
Time Frame: 5 minutes after hysteroscopy
5 minutes after hysteroscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Juan Fco. Lisón, Dr, University CEU Cardenal Herrera

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 3, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 11, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • UNIVERSITY CARDENAL HERRERA-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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