PainNCT05408611
The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents With Primary Dysmenorrhea
A study testing Acupressure in people with Pain and Dysmenorrhea Primary, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is planned to determine the effect of acupressure applied to adolescents with primary dysmenorrhea on pain, menstrual symptoms and general comfort. The research questions of the research are as follows; Research Questions Is there a difference in pain scores in the post-acupressure intervention group… Read more about this study
- Who is it for?
- Ages 14 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Dysmenorrhea Primary, Signs and Symptoms
- What is being tested?
- Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2023to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Those between the ages of 14-17,
- Willing to participate in the research,
- Open to communication,
- Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days),
- Menstrual pain severity is at least 4 according to the Visual Pain Scale,
- A score of 60 or more on the Menstruation Symptom Scale,
Show all 16Show fewer
- Not using hormonal contraception and intrauterine device,
- Not pregnant and not experiencing pregnancy before,
- Does not have a systemic and chronic disease,
- Have not had a gynecological disorder or surgery before,
- Not using analgesics 6 hours before and during the study period,
- Body mass index <30 kg/m2
- No physical/mental health problems that would prevent/limit acupressure and exercise,
- Not doing regular acupressure,
- No psychiatric problems
- Adolescents without active COVID-19 infection.
Who cannot join
- Not between the ages of 14-17,
- Not willing to participate in the research,
- Closed to communication,
- Not having a regular menstrual period (not occurring at intervals of 21-35 days and lasting more or less than 3-8 days),
- Menstrual pain severity is less than 4 according to the Visual Pain Scale,
- A score below 60 on the Menstruation Symptom Scale,
Show all 16Show fewer
- Using hormonal contraception and intrauterine device,
- Pregnant and experienced pregnancy before,
- Having a systemic and chronic disease,
- Have had a previous gynecological disorder or surgery,
- Using analgesics 6 hours before and during the study period,
- Body mass index ≥30 kg/m2
- Having physical/mental health problems that will prevent/limit acupressure and exercise,
- Regular acupressure
- Having a psychiatric problem
- Adolescents with active COVID-19 infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents With Primary Dysmenorrhea: A Single-Blind Randomized Controlled Trial
In this study, it is planned to determine the effect of acupressure applied to adolescents with primary dysmenorrhea on pain, menstrual symptoms and general comfort. The research questions of the research are as follows; Research Questions
- Is there a difference in pain scores in the post-acupressure intervention group and the placebo group?
- Is there a difference between menstrual symptoms scores in the post-acupressure intervention group and the placebo group?
- Is there a difference between comfort scores in the intervention group and the placebo group after acupressure?
- Is there a difference between the pain scores of the intervention group according to time?
- Is there a difference between the menstrual symptoms scores of the intervention group according to time?
- Is there a difference between the comfort scores of the intervention group according to time? Is there a difference between the pain scores of the placebo group over time? Is there a difference between the menstrual symptoms scores of the placebo group over time?
- Is there a difference between the comfort scores of the placebo group over time?
Read the detailed description
Methods:
Adolescents aged 14-17 years with primary dysmenorrhea will be randomly assigned to the acupressure and control groups. The study group (n=28) and placebo group (n=28) will be applied to the determined points in a certain order. The order of application is Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6). Acupressure will be applied to the adolescents in the groups individually for 18-20 minutes, twice a day in the first three days of their menstrual periods. The primary outcome measures of the study is the effect of acupressure on adolescent pain severity and menstrual symptoms. The secondary outcome measures of the study is the effect of acupressure on general comfort. Data collection forms will be applied four times in total for the second and third cycles, before and immediately after the acupressure application.
- Conditions
- Pain, Dysmenorrhea Primary, Signs and Symptoms
- Being tested
- Acupressure, Placebo acupressure
- Keywords
- Primary dysmenorrhea, acupressure, pain, menstrual symptoms, general comfort
- Medical subject headings
- Pain, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
acupressure is a non-pharmacological method originating from traditional Chinese medicine. According to the National Cancer Institute, acupressure is defined as pressure / massage applied to certain parts of the body to control symptoms such as pain or nausea. The main purpose of acupressure is to stimulate the regions associated with the specific organ by applying pressure with energy channels called meridians.
Placebo acupressureOther
Placebo acupressure is manual pressure applied to unreal acupressure points.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (acupressure) group | Experimental | Acupressure (complementary and integrative medicine method) Acupressure will be applied individually to the experimental group for 15 minutes three times a day for three menstrual cycles (approximately 3 months). Data collection forms will be applied 4 times in total, before the intervention, at the end of Cycle 1, cycle 2, and cycle 3 (each cycle is 28 days) Receives: Other: Acupressure |
| Plasebo group | Placebo comparator | Placebo acupressure will be performed at any point within 1.5 cm of the actual acupressure points.
Placebo acupressure will be applied individually to the placebo group for 15 minutes three times a day for three menstrual cycles (approximately 3 months). Data collection forms will be applied 4 times in total, before the intervention, at the end of Cycle 1, cycle 2, and cycle 3 (each cycle is 28 days) Receives: Other: Placebo acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain will be evaluated by using the "Visual Analog Skala (VAS)" . The Visual Analog Scale is used to measure the pain perceived by the person. There is a 10 cm mark on the one end of the scale, where there is no pain (zero), and on the other end there is the most severe (10) pain. Between the (100 mm.) part, the individual can indicate his or her pain by drawing a line, putting a dot or pointing. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the value found indicates the severity of the individual's pain. In the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, while 75-100 mm indicates severe pain.
Measured: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Menstrual Symptom Questionnaire (MSQ)
Menstrual symptoms will be evaluated by using the "Menstrual Symptom Questionnaire ". The Menstrual Symptom Questionnaire was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. The scale, which is a five-point Likert type and consists of 24 items, was updated by Negriff et al. in 2009 by re-evaluating its factor structure and usability. The MSQ score is calculated by taking the total mean score of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The original Cronbach's Alpha value of the scale was .86 and had three sub-dimensions: "Negative Effects/Somatic Complaints", "Menstrual Pain" and "Abdominal Pain".
The Turkish validity and reliability study of the Menstruation Symptom Questionnaire was performed by Güvenç et al. in 2014. Two items (6th and 17th items) in the original of the scale were removed from the scale because they had an item-total score correlation of less than 0.30. The scale
Measured: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Secondary outcomes (1)
General Comfort Scale (GAS)
Comfort level will be evaluated by using the "General Comfort Scale (GAS)". It was developed by Kolcaba (1992) by taking the taxonomic structure, which includes three levels and four dimensions that make up the theoretical components of comfort, as a guide. The GAQ, which is suitable for Turkish society by Kuğuoğlu and Karabacak (2008), is of four and six-point Likert type, contains 24 positive and 24 negative items, and the response patterns are given in mixed form. The scale consists of three levels: relief (16 items), relaxation (17 items) and overcoming problems (15 items); It consists of four dimensions, namely the physical dimension (12 items), the psychospiritual dimension (13 items), the environmental dimension (13 items), and the sociocultural dimension (10 items). In the evaluation of the scale; Negative scores obtained are reverse coded and added up with positive items. The highest total score that can be obtained from the scale is 192, and the lowest total score is 48. The
Measured: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start17 Apr 2023
- Primary completion15 Aug 2023
- Study completion15 Nov 2023
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 PainStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Prospective, parallel, two arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahu AKSOY, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408611
- Sponsor's protocol ID
- 000
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aksoy-Can A, Buldum A, Abic A, Vefikulucay-Yilmaz D. The effect of acupressure on pain, menstrual symptoms, and comfort in adolescents with primary dysmenorrhea: a single-blind randomized controlled trial. BMC Complement Med Ther. 2025 Jul 2;25(1):221. doi: 10.1186/s12906-025-04965-0.
PubMed 40605053
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Pain, Menstrual Symptoms, and General Comfort in Adolescents With Primary Dysmenorrhea: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05408611
- Acronym / sponsor ID
- 000
- Conditions
- Pain, Dysmenorrhea Primary, Signs and Symptoms
- Keywords
- Primary dysmenorrhea, acupressure, pain, menstrual symptoms, general comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 7 Jun 2022 (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.
In this study, it is planned to determine the effect of acupressure applied to adolescents with primary dysmenorrhea on pain, menstrual symptoms and general comfort. The research questions of the research are as follows; Research Questions
- Is there a difference in pain scores in the post-acupressure intervention group and the placebo group?
- Is there a difference between menstrual symptoms scores in the post-acupressure intervention group and the placebo group?
- Is there a difference between comfort scores in the intervention group and the placebo group after acupressure?
- Is there a difference between the pain scores of the intervention group according to time?
- Is there a difference between the menstrual symptoms scores of the intervention group according to time?
- Is there a difference between the comfort scores of the intervention group according to time? Is there a difference between the pain scores of the placebo group over time? Is there a difference between the menstrual symptoms scores of the placebo group over time?
- Is there a difference between the comfort scores of the placebo group over time?
Detailed description
Methods:
Adolescents aged 14-17 years with primary dysmenorrhea will be randomly assigned to the acupressure and control groups. The study group (n=28) and placebo group (n=28) will be applied to the determined points in a certain order. The order of application is Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6). Acupressure will be applied to the adolescents in the groups individually for 18-20 minutes, twice a day in the first three days of their menstrual periods. The primary outcome measures of the study is the effect of acupressure on adolescent pain severity and menstrual symptoms. The secondary outcome measures of the study is the effect of acupressure on general comfort. Data collection forms will be applied four times in total for the second and third cycles, before and immediately after the acupressure application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, parallel, two arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental (acupressure) group | Experimental | Other: AcupressureAcupressure (complementary and integrative medicine method) Acupressure will be applied individually to the experimental group for 15 minutes three times a day for three menstrual cycles (approximately 3 months). Data collection forms will be applied 4 times in total, before the intervention, at the end of Cycle 1, cycle 2, and cycle 3 (each cycle is 28 days) |
| Plasebo group | Placebo comparator | Other: Placebo acupressurePlacebo acupressure will be performed at any point within 1.5 cm of the actual acupressure points. Placebo acupressure will be applied individually to the placebo group for 15 minutes three times a day for three menstrual cycles (approximately 3 months). Data collection forms will be applied 4 times in total, before the intervention, at the end of Cycle 1, cycle 2, and cycle 3 (each cycle is 28 days) |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Those between the ages of 14-17,
- Willing to participate in the research,
- Open to communication,
- Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days),
- Menstrual pain severity is at least 4 according to the Visual Pain Scale,
Key exclusion criteria (16 listed)
- Not between the ages of 14-17,
- Not willing to participate in the research,
- Closed to communication,
- Not having a regular menstrual period (not occurring at intervals of 21-35 days and lasting more or less than 3-8 days),
- Menstrual pain severity is less than 4 according to the Visual Pain Scale,
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 |
|---|---|---|
| Acupressureacupressure is a non-pharmacological method originating from traditional Chinese medicine. According to the National Cancer Institute, acupressure is defined as pressure / massage applied to certain parts of the body to control symptoms such as pain or nausea. The main purpose of acupressure is to stimulate the regions associated with the specific organ by applying pressure with energy channels called meridians. | Other | Experimental (acupressure) group |
| Placebo acupressurePlacebo acupressure is manual pressure applied to unreal acupressure points. | Other | Plasebo group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Pain will be evaluated by using the "Visual Analog Skala (VAS)" . The Visual Analog Scale is used to measure the pain perceived by the person. There is a 10 cm mark on the one end of the scale, where there is no pain (zero), and on the other end there is the most severe (10) pain. Between the (100 mm.) part, the individual can indicate his or her pain by drawing a line, putting a dot or pointing. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the value found indicates the severity of the individual's pain. In the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, while 75-100 mm indicates severe pain.
Menstrual Symptom Questionnaire (MSQ)
Time frame: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Menstrual symptoms will be evaluated by using the "Menstrual Symptom Questionnaire ". The Menstrual Symptom Questionnaire was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. The scale, which is a five-point Likert type and consists of 24 items, was updated by Negriff et al. in 2009 by re-evaluating its factor structure and usability. The MSQ score is calculated by taking the total mean score of the items in the scale. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The original Cronbach's Alpha value of the scale was .86 and had three sub-dimensions: "Negative Effects/Somatic Complaints", "Menstrual Pain" and "Abdominal Pain". The Turkish validity and reliability study of the Menstruation Symptom Questionnaire was performed by Güvenç et al. in 2014. Two items (6th and 17th items) in the original of the scale were removed from the scale because they had an item-total score correlation of less than 0.30. The scale
1 secondary outcome
General Comfort Scale (GAS)
Time frame: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 40605053Aksoy-Can A, Buldum A, Abic A, Vefikulucay-Yilmaz D. The effect of acupressure on pain, menstrual symptoms, and comfort in adolescents with primary dysmenorrhea: a single-blind randomized controlled trial. BMC Complement Med Ther. 2025 Jul 2;25(1):221. doi: 10.1186/s12906-025-04965-0.
- The effects of acupressure on severity of primary dysmenorrheaLink provided by the sponsor.
- Effectıveness Of Abdomınal Stretchıng Exercıse And Sanyınjıao Acupressure To Relıeve Dysmenorrhea PaınLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Pain and Dysmenorrhea Primary, run by Mersin 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 16 inclusion and 16 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: finished, as of the sponsor's last update on 13 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: change from before the intervention, at the end of Cycle 1, cycle 2 and cycle 3 (each cycle is 28 days).). The study lists 2 primary outcomes in all. 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 NCT05408611, 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 13 Oct 2026.