Primary DysmenorrheaNCT04356131
Effect of Massage and Progressive Relaxation Exercises on Primary Dysmenorrhea
A study testing progressive relaxation exercises and massage in people with Primary Dysmenorrhea, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
A total of 97 female students, 50 in the intervention group and 47 in the control group, were included in this pretest-posttest design randomized controlled study. Massage and progressive relaxation exercises are self-administered practices that are easy to adopt, with no side effects, and have beneficial effects on… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- progressive relaxation exercises and massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 31 Dec 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being older than 18 years,
- Having a dysmenorrhea pain intensity score ≥4 according to Visual Analog Scale (VAS),
- Having no previous pregnancy experience,
- Having no disease that leads to dysmenorrhea,
- Using no hormonal contraception or intrauterine device,
- Having a menstruation period of 3-8 days and a menstrual cycle of 21-35 days,
- Having no systemic-chronic disease or physical/mental health problems that prevent/restrict massage or exercise,
- Volunteering to participate in the study.
Who cannot join
- Being younger than 18 years
- Having a dysmenorrhea pain intensity score ≤ 4 according to Visual Analog Scale (VAS),
- Having previous pregnancy experience,
- Having disease that leads to dysmenorrhoea (endometriosis, ovarian cysts/tumors, pelvic infection disease, myoma/uterus tumor, uterus polyp, asherman syndrome, infection),
- Using hormonal contraception and intrauterine devices,
- Not to present a menstruation period that lasts 3-8 days and menstrual cycle of 21-35 days,
Show all 9Show fewer
- Having a systemic and chronic disease (diabetes, heart diseases, vein diseases, circulatory disorders, varicosis, blood diseases, etc.),
- Having any physical/mental health problems that prevent/restrict massaging and exercising,
- Not to be voluntary to join the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage and Progressive Relaxation Exercises on Pain Intensity and Menstrual Symptoms of Students With Primary Dysmenorrhoea
A total of 97 female students, 50 in the intervention group and 47 in the control group, were included in this pretest-posttest design randomized controlled study. Massage and progressive relaxation exercises are self-administered practices that are easy to adopt, with no side effects, and have beneficial effects on pain, sweating, fatigue, and gastrointestinal and central nervous system signs. So, it can be asserted that when applied together, massage and progressive relaxation exercises could be more effective in reducing menstrual symptoms than applying them separately.
Read the detailed description
Dysmenorrhea is one of the most frequent problems during menstruation and described as periodic and painful pelvis menstruation among women at reproductive age. It is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea (PD) is defined as suprapubic pelvis pain with cramps that begin a couple hours before menstrual bleeding, after menstrual bleeding, or during the last 12-72 hours of menstruation and occur repeatedly without organic pathology. PD is associated with an increase in prostaglandin production in the endometrium, which causes pain by increasing uterine contractions in the suprapubic region. According to De Sanctis et al., PD prevalence varies between 16% and 93%. It is often seen with sweating, fatigue, gastrointestinal system signs (lack of appetite, nausea, vomiting, diarrhea), and central nervous system signs (dizziness, headache, syncope, and lack of concentration). These symptoms that occur just before or just after menstrual bleeding among women with normal pelvic anatomy may prevent them from attending school and work or joining social activities. Secondary dysmenorrhea is defined as menstrual pain caused by a pathology in the pelvis such as endometriosis. If a patient has pain for 3-6 months, a more comprehensive evaluation of chronic pelvic pain should be performed to evaluate the potential etiologies of secondary dysmenorrhea.
The international literature includes oral contraceptive, nonsteroidal anti-inflammatory, and sedative drugs for the treatment of primary dysmenorrhea. However, the fact that some of these drugs cause side effects such as indigestion, headache, drowsiness, and substance addiction causes individuals to remain indifferent to them. In Turkey, it is reported that women prefer their family members as the first source of information and therefore use individual methods (massage, herbal teas, hot application, lying down, sweet food consumption, etc.) rather than pharmacological treatments due to cultural differences in coping with PD. Complementary and integrated therapy approaches, which are widely used all over the world today, have become common in coping with gynecological disorders among women in recent years. Some studies state that PD can be cured using such complementary therapies as essential oil acids, vitamins, acupuncture, herbal medicines, aromatherapy, reflexology, acupressure, massage, sports, and exercise. However, ACOG emphasizes that although these methods are frequently used by patients, they have not been studied enough yet, and mostly supports the use of exercise, high-frequency transcutaneous electrical nerve stimulation, and topical heat to help manage dysmenorrhea symptoms. Research on PD has applied massage and exercise practices using different application protocols. Studies on massage applications have examined the effect of inhaling herbal essential oils alone or together with massage. Research solely on exercise has examined the effectiveness of long-term and regular exercise, although with various practices. However, it can be said that massage and progressive relaxation exercises are more advantageous than other methods because they are easy, economical, and can be applied without the need for someone else.
Massage intensifies the blood flow in the area of application and reduces muscle tension. It also increases endorphin secretion and raises the pain threshold. Relaxation exercises, on the other hand, provide a decrease in sympathetic activity, an increase in parasympathetic activity and consequently a widening of the peripheral vessels, an increase in blood flow in the blood vessels, and a decrease in muscle tension and pain perception. Moreover, it has been reported that pain, anxiety, and depression symptoms decrease as a result of the decrease in the activation of the sympathetic nervous system, thanks to the deep breathing exercises performed during PRE. Therefore, it is predicted that massage combined with PRE will be beneficial in PD management. In this sense, this study was conducted to examine the effect of massage and PRE together on pain severity and other menstrual symptoms in PD treatment.
The literature includes no studies on the use of massage and PRE together in PD management. Therefore, the aim of the current study was to examine the effect of massage and PRE together on pain intensity and other menstrual symptoms in the management of PD.
- Conditions
- Primary Dysmenorrhea
- Being tested
- progressive relaxation exercises and massage
- Keywords
- Dysmenorrhoea, Massage, Progressive relaxation exercises, Pain, Menstrual symptom, Randomized controlled trial
- Medical subject headings
- Dysmenorrhea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exercises and massageOther
Progressive relaxation exercises included 30 minute rhythmic breathing and muscle relaxation exercises were demonstrated in the second part of the CD with river sounds and verbal instructions. Massage techniques were performed on the site between upper symphysis pubis and umbilicus with 15 minute effleurage demonstrated in the third part of the CD with nature sound.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Students in the experimental group were taught about massage and progressive relaxation exercises (PRE). The phases of the massage and PRE trainings were first explained by being demonstrated by the author on herself. In the meantime, the trainings were video-taped and uploaded to the mobile phones of the students. After the author, each student was made to perform massage and PRE. Both the exercises and massage techniques were daily performed 3 times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes consecutively Receives: Other: progressive relaxation exercises and massage |
| control group | No intervention | The students in the control group continued their routines during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students' individual and menstruation-related characteristics as assessed by "The Personal Information Form".
At the pretest stage of the research, by the experimental group and control group, "The Personal Information Form" form is filled in to specify individual characteristics and menstruation period characteristics.
Measured: 1 day
Secondary outcomes (2)
Students' Menstruation Period Pain as assessed by The short-form McGill Pain Questionnaire.
By the experimental group in each menstrual period for 3 consecutive months: both the exercises and massage techniques were daily performed three times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes and after that the form is filled in.
Without any application by the control group the form is filled in after pain start.
In the form, pain quality is determined with 15 descriptors that describe sensory (first 11) and affective pain (last 4). Dimension of pain is evaluated to demonstrate the intensity by using a rating of 0-3 (0=none, 1=mild, 2=moderate, 3=severe). Pain quality scores of sensory pain (0-33 score), of affective pain (0-12 score) and of total (0- 45 score) are obtained. A rise in total pain quality score indicates a rise in pain sensory. In the study in order to provide an overall intensity score; Visual analog scale is included in the scale. Visual analog scale suggests general pain intensity.
Measured: 28 day
Students' Menstruation Period Menstrual Symptoms as assessed by Daily Symptom Rating Scale.
By the experimental group in each menstrual period for 3 consecutive months: both the exercises and massage techniques were daily performed three times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes and after that "Daily Symptom Rating Scale" form is filled in.
Without any application by the control group "Daily Symptom Rating Scale" form is filled in after menstrual symptoms start.
In the scale that includes 17 symptoms, each symptom is scored according to its intensity with a five point rating between 0 and 5. An increase in scores indicates high intensity of the symptoms.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start1 May 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies 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
- The study was done experimentally in pre-test and post-test design and randomized controlled model among students with PD. The sample size was calculated with power analysis. According to calculations, it was found that 58 students were enough for sampling through 95% of power value, 0.05 of confidence interval and 0.88 of effect size. Students who were determined to meet sampling and inclusion criteria through questionnaire and accepted to participate in the study were assigned into the experimental and control groups through randomization. During the follow-up of the three menstruation periods, the number of groups was increased in case of drop-out and 100 students were included. However, the study was completed with a total of 97 students -50 students for the experimental group and 47 students for the control group- because 3 students of the control group withdrew from the study in the second month.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EBRU YILDIZ, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356131
- Sponsor's protocol ID
- pain management
- Status last verified
- May 2021
- First submitted
- 16 Apr 2020
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Avcı D.K, Sarı E. Approach to dysmenorrhea and effect of dysmenorrhea on social life and school performance in the university students. Van Medical Journal. 2018; 25(2): 188-193.
Azima S, Bakhshayesh H.R, Mousavi S, Ashrafizaveh S. Comparison of the effects of reflexology and massage therapy on primary dysmenorrhea. Biomedical Research. 2015; 26 (3): 0976-1683.
De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.
PubMed 26841639Memmott J. The effect of music-assisted progressive muscle relaxation on the self-reported symptoms of women with primary dysmenorrhoea [PhD thesis]. Kansas: University of Kansas; 2009.
Apay SE, Arslan S, Akpinar RB, Celebioglu A. Effect of aromatherapy massage on dysmenorrhea in Turkish students. Pain Manag Nurs. 2012 Dec;13(4):236-40. doi: 10.1016/j.pmn.2010.04.002. Epub 2010 Sep 15.
PubMed 23158705İbrahimoğlu Ö, Kanan N. The effect of progressive muscle relaxation exercises after endotracheal extubation on vital signs and anxiety level in open heart surgery patients. Turk Journal Intense Care. 2017; 15(3): 98-106.
Mackereth PA, Booth K, Hillier VF, Caress AL. Reflexology and progressive muscle relaxation training for people with multiple sclerosis: a crossover trial. Complement Ther Clin Pract. 2009 Feb;15(1):14-21. doi: 10.1016/j.ctcp.2008.07.002. Epub 2008 Oct 1.
PubMed 19161949
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage and Progressive Relaxation Exercises on Pain Intensity and Menstrual Symptoms of Students With Primary Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT04356131
- Acronym / sponsor ID
- pain management
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhoea, Massage, Progressive relaxation exercises, Pain, Menstrual symptom, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 22 Apr 2020 (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.
A total of 97 female students, 50 in the intervention group and 47 in the control group, were included in this pretest-posttest design randomized controlled study. Massage and progressive relaxation exercises are self-administered practices that are easy to adopt, with no side effects, and have beneficial effects on pain, sweating, fatigue, and gastrointestinal and central nervous system signs. So, it can be asserted that when applied together, massage and progressive relaxation exercises could be more effective in reducing menstrual symptoms than applying them separately.
Detailed description
Dysmenorrhea is one of the most frequent problems during menstruation and described as periodic and painful pelvis menstruation among women at reproductive age. It is classified as primary and secondary dysmenorrhea. Primary dysmenorrhea (PD) is defined as suprapubic pelvis pain with cramps that begin a couple hours before menstrual bleeding, after menstrual bleeding, or during the last 12-72 hours of menstruation and occur repeatedly without organic pathology. PD is associated with an increase in prostaglandin production in the endometrium, which causes pain by increasing uterine contractions in the suprapubic region. According to De Sanctis et al., PD prevalence varies between 16% and 93%. It is often seen with sweating, fatigue, gastrointestinal system signs (lack of appetite, nausea, vomiting, diarrhea), and central nervous system signs (dizziness, headache, syncope, and lack of concentration). These symptoms that occur just before or just after menstrual bleeding among women with normal pelvic anatomy may prevent them from attending school and work or joining social activities. Secondary dysmenorrhea is defined as menstrual pain caused by a pathology in the pelvis such as endometriosis. If a patient has pain for 3-6 months, a more comprehensive evaluation of chronic pelvic pain should be performed to evaluate the potential etiologies of secondary dysmenorrhea.
The international literature includes oral contraceptive, nonsteroidal anti-inflammatory, and sedative drugs for the treatment of primary dysmenorrhea. However, the fact that some of these drugs cause side effects such as indigestion, headache, drowsiness, and substance addiction causes individuals to remain indifferent to them. In Turkey, it is reported that women prefer their family members as the first source of information and therefore use individual methods (massage, herbal teas, hot application, lying down, sweet food consumption, etc.) rather than pharmacological treatments due to cultural differences in coping with PD. Complementary and integrated therapy approaches, which are widely used all over the world today, have become common in coping with gynecological disorders among women in recent years. Some studies state that PD can be cured using such complementary therapies as essential oil acids, vitamins, acupuncture, herbal medicines, aromatherapy, reflexology, acupressure, massage, sports, and exercise. However, ACOG emphasizes that although these methods are frequently used by patients, they have not been studied enough yet, and mostly supports the use of exercise, high-frequency transcutaneous electrical nerve stimulation, and topical heat to help manage dysmenorrhea symptoms. Research on PD has applied massage and exercise practices using different application protocols. Studies on massage applications have examined the effect of inhaling herbal essential oils alone or together with massage. Research solely on exercise has examined the effectiveness of long-term and regular exercise, although with various practices. However, it can be said that massage and progressive relaxation exercises are more advantageous than other methods because they are easy, economical, and can be applied without the need for someone else.
Massage intensifies the blood flow in the area of application and reduces muscle tension. It also increases endorphin secretion and raises the pain threshold. Relaxation exercises, on the other hand, provide a decrease in sympathetic activity, an increase in parasympathetic activity and consequently a widening of the peripheral vessels, an increase in blood flow in the blood vessels, and a decrease in muscle tension and pain perception. Moreover, it has been reported that pain, anxiety, and depression symptoms decrease as a result of the decrease in the activation of the sympathetic nervous system, thanks to the deep breathing exercises performed during PRE. Therefore, it is predicted that massage combined with PRE will be beneficial in PD management. In this sense, this study was conducted to examine the effect of massage and PRE together on pain severity and other menstrual symptoms in PD treatment.
The literature includes no studies on the use of massage and PRE together in PD management. Therefore, the aim of the current study was to examine the effect of massage and PRE together on pain intensity and other menstrual symptoms in the management of PD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was done experimentally in pre-test and post-test design and randomized controlled model among students with PD. The sample size was calculated with power analysis. According to calculations, it was found that 58 students were enough for sampling through 95% of power value, 0.05 of confidence interval and 0.88 of effect size. Students who were determined to meet sampling and inclusion criteria through questionnaire and accepted to participate in the study were assigned into the experimental and control groups through randomization. During the follow-up of the three menstruation periods, the number of groups was increased in case of drop-out and 100 students were included. However, the study was completed with a total of 97 students -50 students for the experimental group and 47 students for the control group- because 3 students of the control group withdrew from the study in the second month.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: progressive relaxation exercises and massageStudents in the experimental group were taught about massage and progressive relaxation exercises (PRE). The phases of the massage and PRE trainings were first explained by being demonstrated by the author on herself. In the meantime, the trainings were video-taped and uploaded to the mobile phones of the students. After the author, each student was made to perform massage and PRE. Both the exercises and massage techniques were daily performed 3 times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes consecutively |
| control group | No intervention | –The students in the control group continued their routines during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being older than 18 years,
- Having a dysmenorrhea pain intensity score ≥4 according to Visual Analog Scale (VAS),
- Having no previous pregnancy experience,
- Having no disease that leads to dysmenorrhea,
- Using no hormonal contraception or intrauterine device,
Key exclusion criteria (9 listed)
- Being younger than 18 years
- Having a dysmenorrhea pain intensity score ≤ 4 according to Visual Analog Scale (VAS),
- Having previous pregnancy experience,
- Having disease that leads to dysmenorrhoea (endometriosis, ovarian cysts/tumors, pelvic infection disease, myoma/uterus tumor, uterus polyp, asherman syndrome, infection),
- Using hormonal contraception and intrauterine devices,
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 |
|---|---|---|
| progressive relaxation exercises and massageProgressive relaxation exercises included 30 minute rhythmic breathing and muscle relaxation exercises were demonstrated in the second part of the CD with river sounds and verbal instructions. Massage techniques were performed on the site between upper symphysis pubis and umbilicus with 15 minute effleurage demonstrated in the third part of the CD with nature sound. | Other | experimental group |
Primary outcome
Students' individual and menstruation-related characteristics as assessed by "The Personal Information Form".
Time frame: 1 day
At the pretest stage of the research, by the experimental group and control group, "The Personal Information Form" form is filled in to specify individual characteristics and menstruation period characteristics.
2 secondary outcomes
Students' Menstruation Period Pain as assessed by The short-form McGill Pain Questionnaire.
Time frame: 28 day
Students' Menstruation Period Menstrual Symptoms as assessed by Daily Symptom Rating Scale.
Time frame: 28 day
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 12 May 2021.
- BackgroundAvcı D.K, Sarı E. Approach to dysmenorrhea and effect of dysmenorrhea on social life and school performance in the university students. Van Medical Journal. 2018; 25(2): 188-193.
- BackgroundAzima S, Bakhshayesh H.R, Mousavi S, Ashrafizaveh S. Comparison of the effects of reflexology and massage therapy on primary dysmenorrhea. Biomedical Research. 2015; 26 (3): 0976-1683.
- Background: PubMed 26841639De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.
- BackgroundMemmott J. The effect of music-assisted progressive muscle relaxation on the self-reported symptoms of women with primary dysmenorrhoea [PhD thesis]. Kansas: University of Kansas; 2009.
- Background: PubMed 23158705Apay SE, Arslan S, Akpinar RB, Celebioglu A. Effect of aromatherapy massage on dysmenorrhea in Turkish students. Pain Manag Nurs. 2012 Dec;13(4):236-40. doi: 10.1016/j.pmn.2010.04.002. Epub 2010 Sep 15.
- Backgroundİbrahimoğlu Ö, Kanan N. The effect of progressive muscle relaxation exercises after endotracheal extubation on vital signs and anxiety level in open heart surgery patients. Turk Journal Intense Care. 2017; 15(3): 98-106.
- Background: PubMed 19161949Mackereth PA, Booth K, Hillier VF, Caress AL. Reflexology and progressive muscle relaxation training for people with multiple sclerosis: a crossover trial. Complement Ther Clin Pract. 2009 Feb;15(1):14-21. doi: 10.1016/j.ctcp.2008.07.002. Epub 2008 Oct 1.
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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 progressive relaxation exercises and massage in people with Primary Dysmenorrhea, 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 8 inclusion and 9 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 12 May 2021. 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. 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?
Students' individual and menstruation-related characteristics as assessed by "The Personal Information Form". (time frame: 1 day). 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 NCT04356131, which also lists 7 linked publications.
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 12 May 2021.