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RecruitingNCT06741059Updated Mar 20, 2025

Effect of TENS on Pain and Symptoms in Primary Dysmenorrhea

An interventional study of Transkutanöz Elektriksel Sinir Stimülasyonu - TENS in Dysmenorrhea, sponsored by Osmaniye Korkut Ata University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by Osmaniye Korkut Ata University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Dysmenorrhea

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Keywords

  • Primary Dysmenorrhea
  • Transcutaneous Electric Nerve Stimulation
  • Menstrual Pain
  • nursing
03

In context

Dysmenorrhea

430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.

This study's planned enrollment of 93 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Osmaniye Korkut Ata University is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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: Women with the following conditions were excluded from the study:

  • Secondary dysmenorrhea
  • Using oral
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
93 participants (estimated)

Study arms

  • Experimental
    The group receiving the TENS treatment

    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

  • No intervention
    Control Group

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

Interventions

  • OtherTranskutanöz 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

06

What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

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

    Transcutaneous Electrical Nerve Stimulation (TENS) is effective in managing menstrual symptoms in women with primary dysmenorrhea.A scale was developed by Taylor in 1979 to assess the symptoms and intensity of symptoms that occur during menstruation. The Turkish validity and reliability of the scale was performed by Oskay et al. in 2008. The scale, which contains seventeen items, has no sub-dimensions with each symptom being scored between 0 and 5. An increase in score indicates an increase in the intensity of the symptoms

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Esra Ünal
    Osmaniye, 80010, Turkey
    Recruiting
    • Kadir Dündar · Contact
08

References and documents

Individual participant data

Plan to share: No — I will share the study results, but individual forms will not be shared because they require patient consent.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Mar 2025, 2 months after the start.

Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 2 months is below that.

Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2024
First posted
Dec 18, 2024
StartActual
Dec 20, 2024
Primary completionEst.
Mar 10, 2025
CompletionEst.
May 25, 2025
Last update
Mar 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06741059
Lead sponsor
Osmaniye Korkut Ata University
Responsible party
ESRA ÜNAL (Dr, Osmaniye Korkut Ata University) — Principal investigator
First posted
Dec 18, 2024
Start date
Dec 20, 2024
Primary completion
Mar 10, 2025 (estimated)
Completion
May 25, 2025 (estimated)
Last update
Mar 20, 2025

Study contacts

Esra U Unal, Doctor
Contact
esraunal2428@gmail.com
+905342878405

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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