Effect of TENS on Pain and Symptoms in Primary Dysmenorrhea

NCT ID: NCT06741059

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-05-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea

Primary dysmenorrhea is a common health problem experienced by women during their menstrual periods, significantly affecting their quality of life. It is often characterized by severe abdominal pain, cramp-like symptoms, nausea, headaches, and fatigue. These symptoms can impact social and functional activities, and in some cases, restrict participation in daily routines.

The treatment of primary dysmenorrhea aims to alleviate symptoms and help women experience a more comfortable menstrual period. Traditional treatments include pain relievers, hormonal therapies, and lifestyle changes. However, these methods may not always be sufficient, or some women may avoid them due to potential side effects.

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.

This study aims to evaluate the effects of TENS on pain and menstrual symptoms in women with primary dysmenorrhea. The research will assess the potential of TENS to reduce menstrual pain and compare its effectiveness with other treatment options. If TENS proves to be effective in managing dysmenorrhea symptoms, it could enhance women's quality of life and provide a valuable non-pharmacological treatment alternative.

The findings of this study could contribute to understanding the role of TENS in alleviating dysmenorrhea symptoms and developing effective treatment strategies to improve women's quality of life during their menstrual periods.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysmenorrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This design allows for direct comparison of the active intervention, placebo, and no intervention (control), evaluating the impact of the treatment on the outcomes.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The group receiving the TENS treatment

The group has received the TENS treatment.

Group Type EXPERIMENTAL

Transkutanöz Elektriksel Sinir Stimülasyonu - TENS

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Transkutanöz Elektriksel Sinir Stimülasyonu - TENS

Intervention Type 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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transkutanöz Elektriksel Sinir Stimülasyonu - TENS

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Osmaniye Korkut Ata University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ESRA ÜNAL

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Esra Ünal

Osmaniye, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Esra U Unal, Doctor

Role: CONTACT

+905342878405

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kadir Dündar

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OKU-SBF-EU-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.