DysmenorrheaNCT06741059
Effect of TENS on Pain and Symptoms in Primary Dysmenorrhea
A study testing Transkutanöz Elektriksel Sinir Stimülasyonu - TENS in people with Dysmenorrhea, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Transkutanöz Elektriksel Sinir Stimülasyonu - TENS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 25 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 contraceptives
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Esra Ünal
Osmaniye, 80010
Kadir Dündar
About this study
Official title: Determining the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea
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.
- Conditions
- Dysmenorrhea
- Being tested
- Transkutanöz Elektriksel Sinir Stimülasyonu - TENS
- Keywords
- Primary Dysmenorrhea, Transcutaneous Electric Nerve Stimulation, Menstrual Pain, nursing
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transkutanöz Elektriksel Sinir Stimülasyonu - TENSOther
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
| Study group | Role | What they receive |
|---|---|---|
| The group receiving the TENS treatment | Experimental | The group has received the TENS treatment. Receives: 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. Receives: Other: Transkutanöz Elektriksel Sinir Stimülasyonu - TENS |
| Control Group | No intervention | It is the control group, which receives no intervention or standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Dec 2024
- Primary completion10 Mar 2025 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This design allows for direct comparison of the active intervention, placebo, and no intervention (control), evaluating the impact of the treatment on the outcomes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA ÜNAL, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741059
- Sponsor's protocol ID
- OKU-SBF-EU-01
- Status last verified
- Mar 2025
- First submitted
- 16 Dec 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will share the study results, but individual forms will not be shared because they require patient consent.
Publications
Unal E. Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Menstrual Symptoms in Primary Dysmenorrhea: A Placebo-Controlled Study. J Midwifery Womens Health. 2026 Jun 7. doi: 10.1111/jmwh.70138. Online ahead of print.
PubMed 42252834
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06741059
- Acronym / sponsor ID
- OKU-SBF-EU-01
- Conditions
- Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Transcutaneous Electric Nerve Stimulation, Menstrual Pain, nursing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This design allows for direct comparison of the active intervention, placebo, and no intervention (control), evaluating the impact of the treatment on the outcomes.
| Arm | Type | Receives |
|---|---|---|
| The group receiving the TENS treatment | Experimental | Other: Transkutanöz Elektriksel Sinir Stimülasyonu - TENSThe group has received the TENS treatment. |
| Placebo Comparator | Placebo comparator | Other: Transkutanöz Elektriksel Sinir Stimülasyonu - TENSIt is the placebo group where the TENS device is applied, but no treatment is given. |
| Control Group | No intervention | –It is the control group, which receives no intervention or standard treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
- Secondary dysmenorrhea
- Using oral contraceptives
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transkutanöz Elektriksel Sinir Stimülasyonu - TENSTranscutaneous 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 | Other | Placebo Comparator, The group receiving the TENS treatment |
Primary outcome
Transcutaneous Electrical Nerve Stimulation
Time frame: 3 months
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.
1 secondary outcome
Transcutaneous Electrical Nerve Stimulation (TENS) is effective in managing menstrual symptoms in women with primary dysmenorrhea.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 42252834Unal E. Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Menstrual Symptoms in Primary Dysmenorrhea: A Placebo-Controlled Study. J Midwifery Womens Health. 2026 Jun 7. doi: 10.1111/jmwh.70138. Online ahead of print.
- Individual participant dataSharing planned: No. I will share the study results, but individual forms will not be shared because they require patient consent.
Related trials for Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transkutanöz Elektriksel Sinir Stimülasyonu - TENS in people with Dysmenorrhea, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra U Unal, Doctor (+905342878405, esraunal2428@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous Electrical Nerve Stimulation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06741059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.