Primary DysmenorrheaNCT07409337
Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms
A study testing Self-Acupressure in people with Primary Dysmenorrhea and Premenstrual Syndrome, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on menstrual pain severity and premenstrual symptoms in women aged 18-30 years with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Premenstrual Syndrome, Menstrual Pain
- What is being tested?
- Self-Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Dec 2026
- 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 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 18 to 30 years
- Regular menstrual cycles (21-35 days)
- Diagnosis of primary dysmenorrhea with moderate to severe menstrual pain
- Presence of premenstrual symptoms consistent with premenstrual syndrome
- Currently enrolled as a university student
- Willingness to perform self-acupressure as instructed for approximately six menstrual cycles
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Secondary dysmenorrhea (e.g., endometriosis, uterine fibroids, pelvic inflammatory disease)
- Current use of hormonal contraceptives or hormonal therapy within the past 3 months
- Pregnancy or breastfeeding
- Chronic gynecological, endocrine, or systemic disease that may affect menstrual pain or symptoms
- Regular use of analgesic or anti-inflammatory medications outside menstruation
- Prior formal training or regular practice of acupuncture or acupressure
- Inability to comply with study procedures or follow-up schedule
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
Niğde Ömer Halisdemir University Hospital
Niğde, Merkez, 51240
Pınar Erdoğan, Assoc. Prof., 05233646954, drpinarerdogan@gmail.com
About this study
Official title: Effects of Self-Acupressure on Primary Dysmenorrhea and Premenstrual Symptoms in Women Aged 18-30: A Randomized, Sham-Controlled, 6-Month Trial
This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on menstrual pain severity and premenstrual symptoms in women aged 18-30 years with primary dysmenorrhea. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be applied during the premenstrual and menstrual periods over approximately six months. The primary outcome is the change in menstrual pain severity, and secondary outcomes include changes in premenstrual symptom severity, analgesic use, and menstruation-related activity limitation.
Read the detailed description
Primary dysmenorrhea and premenstrual syndrome are highly prevalent conditions among women of reproductive age and are associated with substantial impairment in quality of life, academic or work performance, and daily functioning. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs and hormonal contraceptives are commonly used, they may be ineffective, contraindicated, or undesirable for some individuals. Therefore, non-pharmacological, low-cost, and self-administered approaches are of clinical interest.
This study is a randomized, parallel-group, sham-controlled clinical trial designed to investigate the effectiveness of a self-acupressure protocol on menstrual pain and premenstrual symptoms. Eligible participants are women aged 18-30 years with regular menstrual cycles and clinically significant primary dysmenorrhea and premenstrual symptoms. Participants are randomized in a 1:1 ratio to either a verum self-acupressure group or a sham self-acupressure group.
The verum intervention consists of self-administered acupressure applied to predefined acupoints (SP6, CV4, ST36, and LV3), while the sham intervention uses non-acupoint locations near the same anatomical regions. Both interventions are matched in terms of training, session duration, frequency, and pressure intensity. Participants are instructed to perform acupressure daily during the premenstrual phase and on the first days of menstruation across approximately five to six consecutive menstrual cycles.
Outcome assessments are conducted at baseline and at the end of the six-month follow-up period. The primary outcome is the change in menstrual pain severity measured by a visual analog scale. Secondary outcomes include changes in premenstrual symptom severity scores, analgesic consumption, and menstruation-related school or work absenteeism. Adherence and participant-reported feasibility are also recorded. The study is conducted under minimal-risk conditions, and all participants provide written informed consent prior to enrollment.
- Conditions
- Primary Dysmenorrhea, Premenstrual Syndrome, Menstrual Pain
- Being tested
- Self-Acupressure, Sham Self-Acupressure
- Keywords
- Self-acupressure, Dysmenorrhea, Premenstrual symptoms, Menstrual pain, Non-pharmacological treatment, Sham-controlled trial
- Medical subject headings
- Premenstrual Syndrome, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-AcupressureOther
Participants receive structured training in self-administered acupressure at predefined acupoints (SP6, CV4, ST36, and LV3). Training is provided face-to-face at baseline. Participants are instructed to apply acupressure using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation across approximately six consecutive menstrual cycles.
Sham Self-AcupressureOther
Participants receive structured training in sham self-acupressure matched to the experimental intervention in terms of training format, session duration, frequency, and pressure intensity. Sham acupressure is applied at non-acupoint locations adjacent to the same anatomical regions as the experimental points, using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation across approximately six menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| Self-Acupressure Intervention | Experimental | Participants receive structured training in self-administered acupressure at predefined acupoints (SP6, CV4, ST36, and LV3). Participants are instructed to apply acupressure using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation for approximately six consecutive menstrual cycles. The intervention is performed according to the study protocol in addition to usual care. Receives: Other: Self-Acupressure |
| Sham Self-Acupressure | Sham comparator | Participants receive structured training in sham self-acupressure matched to the experimental intervention in terms of training format, session duration, frequency, and pressure intensity. Sham acupressure is applied at non-acupoint locations adjacent to the same anatomical regions as the experimental points, using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation for approximately six consecutive menstrual cycles. Receives: Other: Sham Self-Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in menstrual pain severity
Change in menstrual pain severity measured using a visual analog scale (VAS, 0-10), where higher scores indicate more severe pain. The primary outcome is defined as the change in mean VAS score from baseline to the end of the 6-month follow-up period.
Measured: Baseline and end of 6 months (approximately 5-6 menstrual cycles)
Secondary outcomes (3)
Change in premenstrual symptom severity
Change in premenstrual symptom severity assessed using a validated premenstrual symptom scale. Higher scores indicate greater symptom severity. Change is defined as the difference between baseline and end-of-study scores.
Measured: Baseline and end of 6 months
Analgesic use during menstruation
Use of analgesic medication during menstruation, recorded as the number of days and/or doses of analgesic intake per menstrual cycle.
Measured: Assessed throughout the 6-month follow-up period
Menstruation-related absenteeism
Number of school or work days missed due to menstrual pain or premenstrual symptoms, self-reported by participants.
Measured: Assessed throughout the 6-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Feb 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group, randomized, sham-controlled clinical trial. Participants are individually randomized in a 1:1 ratio to either a verum self-acupressure intervention or a sham self-acupressure control. There is no crossover between study arms, and all participants are followed for approximately six months.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Erdoğan, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409337
- Sponsor's protocol ID
- 22504254-050.04/18-75
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified data will be stored securely and used only for the purposes of this study and related publications, in accordance with institutional ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-Acupressure on Primary Dysmenorrhea and Premenstrual Symptoms in Women Aged 18-30: A Randomized, Sham-Controlled, 6-Month Trial
- ClinicalTrials.gov ID
- NCT07409337
- Acronym / sponsor ID
- 22504254-050.04/18-75
- Conditions
- Primary Dysmenorrhea, Premenstrual Syndrome, Menstrual Pain
- Keywords
- Self-acupressure, Dysmenorrhea, Premenstrual symptoms, Menstrual pain, Non-pharmacological treatment, Sham-controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on menstrual pain severity and premenstrual symptoms in women aged 18-30 years with primary dysmenorrhea. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be applied during the premenstrual and menstrual periods over approximately six months. The primary outcome is the change in menstrual pain severity, and secondary outcomes include changes in premenstrual symptom severity, analgesic use, and menstruation-related activity limitation.
Detailed description
Primary dysmenorrhea and premenstrual syndrome are highly prevalent conditions among women of reproductive age and are associated with substantial impairment in quality of life, academic or work performance, and daily functioning. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs and hormonal contraceptives are commonly used, they may be ineffective, contraindicated, or undesirable for some individuals. Therefore, non-pharmacological, low-cost, and self-administered approaches are of clinical interest.
This study is a randomized, parallel-group, sham-controlled clinical trial designed to investigate the effectiveness of a self-acupressure protocol on menstrual pain and premenstrual symptoms. Eligible participants are women aged 18-30 years with regular menstrual cycles and clinically significant primary dysmenorrhea and premenstrual symptoms. Participants are randomized in a 1:1 ratio to either a verum self-acupressure group or a sham self-acupressure group.
The verum intervention consists of self-administered acupressure applied to predefined acupoints (SP6, CV4, ST36, and LV3), while the sham intervention uses non-acupoint locations near the same anatomical regions. Both interventions are matched in terms of training, session duration, frequency, and pressure intensity. Participants are instructed to perform acupressure daily during the premenstrual phase and on the first days of menstruation across approximately five to six consecutive menstrual cycles.
Outcome assessments are conducted at baseline and at the end of the six-month follow-up period. The primary outcome is the change in menstrual pain severity measured by a visual analog scale. Secondary outcomes include changes in premenstrual symptom severity scores, analgesic consumption, and menstruation-related school or work absenteeism. Adherence and participant-reported feasibility are also recorded. The study is conducted under minimal-risk conditions, and all participants provide written informed consent prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, randomized, sham-controlled clinical trial. Participants are individually randomized in a 1:1 ratio to either a verum self-acupressure intervention or a sham self-acupressure control. There is no crossover between study arms, and all participants are followed for approximately six months.
| Arm | Type | Receives |
|---|---|---|
| Self-Acupressure Intervention | Experimental | Other: Self-AcupressureParticipants receive structured training in self-administered acupressure at predefined acupoints (SP6, CV4, ST36, and LV3). Participants are instructed to apply acupressure using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation for approximately six consecutive menstrual cycles. The intervention is performed according to the study protocol in addition to usual care. |
| Sham Self-Acupressure | Sham comparator | Other: Sham Self-AcupressureParticipants receive structured training in sham self-acupressure matched to the experimental intervention in terms of training format, session duration, frequency, and pressure intensity. Sham acupressure is applied at non-acupoint locations adjacent to the same anatomical regions as the experimental points, using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation for approximately six consecutive menstrual cycles. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female participants aged 18 to 30 years
- Regular menstrual cycles (21-35 days)
- Diagnosis of primary dysmenorrhea with moderate to severe menstrual pain
- Presence of premenstrual symptoms consistent with premenstrual syndrome
- Currently enrolled as a university student
Key exclusion criteria (7 listed)
- Secondary dysmenorrhea (e.g., endometriosis, uterine fibroids, pelvic inflammatory disease)
- Current use of hormonal contraceptives or hormonal therapy within the past 3 months
- Pregnancy or breastfeeding
- Chronic gynecological, endocrine, or systemic disease that may affect menstrual pain or symptoms
- Regular use of analgesic or anti-inflammatory medications outside menstruation
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 |
|---|---|---|
| Self-AcupressureParticipants receive structured training in self-administered acupressure at predefined acupoints (SP6, CV4, ST36, and LV3). Training is provided face-to-face at baseline. Participants are instructed to apply acupressure using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation across approximately six consecutive menstrual cycles. | Other | Self-Acupressure Intervention |
| Sham Self-AcupressureParticipants receive structured training in sham self-acupressure matched to the experimental intervention in terms of training format, session duration, frequency, and pressure intensity. Sham acupressure is applied at non-acupoint locations adjacent to the same anatomical regions as the experimental points, using moderate, comfortable, non-painful pressure during the premenstrual phase and the first days of menstruation across approximately six menstrual cycles. | Other | Sham Self-Acupressure |
Primary outcome
Change in menstrual pain severity
Time frame: Baseline and end of 6 months (approximately 5-6 menstrual cycles)
Change in menstrual pain severity measured using a visual analog scale (VAS, 0-10), where higher scores indicate more severe pain. The primary outcome is defined as the change in mean VAS score from baseline to the end of the 6-month follow-up period.
3 secondary outcomes
Change in premenstrual symptom severity
Time frame: Baseline and end of 6 months
Analgesic use during menstruation
Time frame: Assessed throughout the 6-month follow-up period
Menstruation-related absenteeism
Time frame: Assessed throughout the 6-month follow-up period
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 24 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified data will be stored securely and used only for the purposes of this study and related publications, in accordance with institutional ethics approval.
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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 Self-Acupressure in people with Primary Dysmenorrhea and Premenstrual Syndrome, run by Nigde Omer Halisdemir 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 7 inclusion and 7 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 24 Aug 2026. 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 Pınar Erdoğan, Assoc. Prof. (+905233646954, drpinarerdogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in menstrual pain severity (time frame: Baseline and end of 6 months (approximately 5-6 menstrual cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.