Effect of TENS on Pain and Symptoms in Primary Dysmenorrhea

NCT06741059 | Recruiting

• 1 other identifier: OKU-SBF-EU-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea This study aims to investigate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in managing pain and alleviating menstrual symptoms in individuals with primary dysmenorrhea. Primary dysmenorrhea is characterized by severe menstrual pain and accompanying symptoms that negatively impact the quality of life and daily functioning. TENS, a non-invasive and drug-free method, is applied to relieve pain by stimulating nerves through electrical impulses. This research evaluates the impact of TENS on both the intensity of menstrual pain and associated symptoms, offering insights into its potential as an alternative or complementary therapeutic approach.

Conditions

Dysmenorrhea

Keywords

Primary Dysmenorrhea; Transcutaneous Electric Nerve Stimulation; Menstrual Pain; nursing

Outcome Measures

Primary Outcomes (1)

• Transcutaneous Electrical Nerve Stimulation

  Transcutaneous Electrical Nerve Stimulation (TENS) is effective in pain management in women with primary dysmenorrhea. The Visual Analog Scale is a scale where the patient can mark their own pain on a ruler that can be used horizontally or vertically, where the pain is evaluated between 0-10. VCS is used to evaluate both the severity of pain and the effectiveness of the treatment/intervention on pain in various populations. An increase in the score indicates an increase in pain.

  3 months

Secondary Outcomes (1)

• Transcutaneous Electrical Nerve Stimulation (TENS) is effective in managing menstrual symptoms in women with primary dysmenorrhea.

  3 months

Study Arms (3)

The group receiving the TENS treatment

EXPERIMENTAL

The group has received the TENS treatment.

Other: Transkutanöz Elektriksel Sinir Stimülasyonu - TENS

Placebo Comparator

PLACEBO COMPARATOR

It is the placebo group where the TENS device is applied, but no treatment is given.

Other: Transkutanöz Elektriksel Sinir Stimülasyonu - TENS

Control Group

NO INTERVENTION

It is the control group, which receives no intervention or standard treatment.

Interventions

Transkutanöz Elektriksel Sinir Stimülasyonu - TENS OTHER

Transcutaneous Electrical Nerve Stimulation (TENS) has gained popularity in recent years as a non-invasive method for pain management. TENS works by modulating nerve stimulation through low-frequency electrical currents applied to the skin, reducing pain perception. Its potential effectiveness in alleviating menstrual pain has drawn increasing attention as an alternative treatment option

Placebo Comparator; The group receiving the TENS treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and above
• Have regular menstrual cycles (lasting 3 to 8 days, with a menstrual cycle range of 21 to 35 days)
• Have dysmenorrhea pain severity rated 4 or higher on the Visual Analog Scale (VAS)

You may not qualify if:

• Secondary dysmenorrhea
• Using oral contraceptives
• Having impaired tissue integrity in the abdominal area
• Having previous experience with TENS
• Having a history of nerve damage or sensory loss
• Having a pacemaker
• Having any systemic diseases
• Being pregnant or in the postpartum period

Sponsors & Collaborators

• Osmaniye Korkut Ata University: lead

Study Sites (1)

Esra Ünal

Osmaniye, 80010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Esra U Unal, Doctor

CONTACT

+905342878405; esraunal2428@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study Design: This study follows a parallel design with three groups: Experimental Group: Participants in this group receive the active intervention (e.g., Transcutaneous Electrical Nerve Stimulation - TENS). Placebo Group: Participants in this group receive a placebo treatment (e.g., a sham TENS treatment or a non-active intervention). Control Group: Participants in this group receive no intervention or the standard treatment. Blinding: A single-blind design is used in this study, meaning only the participants do not know which group they are assigned to. The research team is aware of the group assignments. This approach helps prevent the participants' expectations from influencing the results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This design allows for direct comparison of the active intervention, placebo, and no intervention (control), evaluating the impact of the treatment on the outcomes.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 18, 2024
• Study Start: December 20, 2024
• Primary Completion: March 10, 2025
• Study Completion: May 25, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)