TENS Efficacy in Pain Relief During Hysteroscopy

NCT04229576 | Completed

• 1 other identifier: TENS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Pain during procedures

  5 minutes after procedures

• The duration of procedures

  5 minutes after procedures

• vital parameters

  5 minutes after procedures

• Vital parameters

  5 minutes after procedures

• Vital parameters

  5 minutes after saturation

Study Arms (2)

Using TENS to relief pain during hystroscopy

ACTIVE COMPARATOR

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, the TENS output intensity will be increased during the treatment every time the patient accommodated to the TENS stimulus.

Device: TENs

Using placebo TENS (not active) during hystroscopy

PLACEBO COMPARATOR

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.

Device: TENs

Interventions

TENs DEVICE

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

Using TENS to relief pain during hystroscopy; Using placebo TENS (not active) during hystroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal endometrial thickening \>4mm.
• Suspicious endometrial polyp or leiomyoma.
• Infertility study.
• Menstrual disorder.
• Suspicious endometrial carcinoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ebtihal Sameih Ali Alnomany

Cairo, 55500, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ebtihal Sa Ali

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 18, 2020
• Study Start: March 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Completed study
• Access Criteria: Data access will be reviewed by an external independant review panel. Requests will be required to sign a data access agreement

Locations

EG (1)