- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647008
Pain Relief During Unsedated Office Hysteroscopy by Applying TENS
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
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Moncada, Valencia, Spain, 46113
- Universidad CEU Cardenal Herrera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Juan Fco. Lisón, Dr, University CEU Cardenal Herrera
Publications and helpful links
General Publications
- Amer-Cuenca JJ, Goicoechea C, Girona-Lopez A, Andreu-Plaza JL, Palao-Roman R, Martinez-Santa G, Lison JF. Pain relief by applying transcutaneous electrical nerve stimulation (TENS) during unsedated colonoscopy: a randomized double-blind placebo-controlled trial. Eur J Pain. 2011 Jan;15(1):29-35. doi: 10.1016/j.ejpain.2010.05.006. Epub 2010 Jun 9.
- Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UNIVERSITY CARDENAL HERRERA-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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