TENS Efficacy in Pain Relief During Hysteroscopy

Pain Clinical Trial

Official title:

Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229576
• Other study ID #: TENS
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized controlled trial

Description:

Patients fulfilling inclusion criteria will be distributed in two groups, each one will be (60) patients (more than sample size number) to avoid the drop in the size of the study.

Group (A):(60) Active TENS during office hysteroscopy. Group (B)(60) placebo TENS during office hysteroscopy. The active TENS intervention consisted of a varying high-frequency (80-100 Hz), pulse duration 400-microseconds.Transcutaneous electrical nerve stimulation therapy will be initiated 5 minutes before starting the hysteroscopy and for the duration of the procedure. Two sets of two self-adhesive electrodes (circular pads) will be placed parallel to the spinal cord at the T10-L1 and S2-S4 levels .

Group (A)(60) Active TENs during office hysteroscopy The device intensity (amplitude) will be individually adjusted to each participant's maximum sensory level (strongest reported tingling feeling without pain and with no muscle contractions. Patients will be informed about the importance of maintaining the stimulation at a maximum non painful level. Thus, the TENS output intensity will be increased during the treatment every time the patient accommodated to the TENS stimulus. All the hysteroscopies will be performed by the same experienced consultant in (ECDU), who will be blinded to the patients' group allocations. Uterine cavity will be distended with normal saline

Group (B):(60) placebo TENs during office hysteroscopy To achieve blinding in the placebo group, participants will be connected to the TENS unit in exactly the same way as participants in the active TENS group with the unit emitting the active indicator light and sound but delivering no electrical stimulation.

Primary Outcome Measures :

The level of pain at the end of office hysteroscopy procedure (primary outcome) will be measured 5 minutes after procedure on a 100-mm-long horizontal line visual analog scale (VAS; 0 mm=no pain and 100 mm=worst possible pain).

A discrete, 5-point, verbal Likert scale including the following options: "no pain," "minimal pain," "moderate pain," "severe pain," and "worst pain possible," will be used to assess the internal consistency of the pain rating 5 minutes after procedure.

Secondary Outcome Measures The pain of hysteroscopy entry, contact, and biopsy. The duration of the procedure, vital parameters (blood pressure, heart rate, arterial oxygen saturation), vasovagal symptoms (dizzin ess, nausea, vomiting, shoulder pain, vertigo, sweating, or fainting), and unusual or adverse TENS events (skin allergy, pain, or burning at the electrode site) will be recorded during all the hysteroscopy procedures.

Finally, the level of satisfaction with the hysteroscopy, as indicated on a scale of ( 0-10), was measured at the end of the procedure .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal endometrial thickening >4mm.

• Suspicious endometrial polyp or leiomyoma.

• Infertility study.

• Menstrual disorder.

• Suspicious endometrial carcinoma

Exclusion Criteria:

• • Genital infection.

• Undiagnosed genital bleeding.

• Contraindication to office hysteroscopy.

• 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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• TENs
Assessing the efficacy of TENs in pain relieve during office hysteroscopy .

Locations

Country	Name	City	State
Egypt	Ebtihal Sameih Ali Alnomany	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of pain:visual analog scale	Using visual analog scale VAS; 0 mm=no pain and 100 mm=worst possible pain).	5 minutes after procedures
Primary	Verbal likert scale	A discrete, 5-point, verbal Likert scale including the following options: "no pain," "minimal pain," "moderate pain," "severe pain," and "worst pain possible," was also used to assess the internal consistency of the pain rating within the study.	5 minutes after procedures
Secondary	Pain during procedures	The pain of hysteroscopy entry, contact, and biopsy.	5 minutes after procedures
Secondary	The duration of procedures	The duration of procesures	5 minutes after procedures
Secondary	vital parameters	Blood pressure	5 minutes after procedures
Secondary	Vital parameters	Heart rate	5 minutes after procedures
Secondary	Vital parameters	Arterial oxygen saturation	5 minutes after saturation
Secondary	Vasovagal symptoms	vasovagal symptoms (dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, or fainting)	5 minutes after procedures
Secondary	TENS advers effect	unusual or adverse TENS events (skin allergy, pain, or burning at the electrode site) will be recorded during all the hysteroscopy procedures.	5 minutes after procedures
Secondary	Level of satisfaction	Finally, the level of satisfaction with the hysteroscopy, as indicated on a scale of ( 0-10), was measured at the end of the procedure .	5 minutes after procedures