Primary DysmenorrheaNCT06250660
The Effectiveness of an Intervention of Fresh Strawberries on Menstrual Pain and Menstrual Distress
A study testing Strawberry Intervention in people with Primary Dysmenorrhea and Menstrual Pain, run by Cynthia del Rocío Márquez Beltrán at 1 site in Spain.
Trial summary
The purpose of this project is to know the effectiveness of an intervention based on the consumption of fresh strawberries from the Huelva region on menstrual pain and menstrual distress in young university students with primary dysmenorrhea, compared to a control group of students. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Menstrual Pain, Menstrual Distress \(Dysmenorrhea\)
- What is being tested?
- Strawberry Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 2 Apr 2024to 6 Jun 2024
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women
- Suffer menstrual pain at least 1 time in the last 6 months or 3 times in the last year
- Without a history of diagnosed gynecological pathology
- Not taking hormonal contraception
- Being enrolled at the University of Huelva for the academic year 2023/2024
Who cannot join
- Those who do not meet the inclusion criteria
- Being in the process of mobility during the months of study
- Have had an abortion
- Suffer from a problem that requires limiting the consumption of fruit or strawberries in their diet
- Suffer from a chronic disease that causes pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Intervention Based on the Consumption of Fresh Strawberries From the Huelva Region on Menstrual Pain and Menstrual Distress in Young University Students
The purpose of this project is to know the effectiveness of an intervention based on the consumption of fresh strawberries from the Huelva region on menstrual pain and menstrual distress in young university students with primary dysmenorrhea, compared to a control group of students.
The participants with dysmenorrhea will be divided into two groups, the assignment will be random to the intervention group with strawberry intake for a month and comparing its effect with de control group. The results of the evaluations carried out prior, to the month and 2 months of the intervention will be compared.
Read the detailed description
Dysmenorrhea is a prevalent problem among women of childbearing age; previous studies carried out among young university students have identified that it affects 74% of them. Dysmenorrhea can also be accompanied by the well-known menstrual distress, which has been estimated to affect between 75 and 94% of women. The symptoms included in menstrual distress are diverse, including irritability, nausea, vomiting, abdominal pain, general weakness or fatigue, among others. Dysmenorrhea and distress have a significant impact on the lives of women who suffer from it, affecting their social life, quality of life and academic and work performance.
The methods that women use to relieve dysmenorrhea are usually pharmacological, with NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and hormonal contraceptives, but these are not free of adverse effects, so more and more studies are investigating non-pharmacological methods to relieve pain. Menstrual distress is also being included as an object of study.
A healthy lifestyle has been shown to be beneficial in relieving primary dysmenorrhoea. In particular, exercise and eating at least 2 pieces of fruit per day have been identified as protective habits.
Most of the studies that evaluate food intake in women with dysmenorrhea are observational and the few clinical trials that exist are with small samples. Strawberries are rich in flavonoids and phenolic acids, giving them anti-inflammatory and antioxidant properties. Studies carried out with strawberries have shown their benefits against chronic inflammatory and cardiovascular diseases. For these reasons, it is necessary a clinical trial to evaluate the benefits of strawberry in relieving dysmenorrhea and menstrual distress.
Carrying out a clinical trial with strawberries is a challenge. Firstly, there is no consensus on the optimal dose that should be ingested to influence health biomarkers. On the other hand, the use of fresh strawberries involves a significant cost, in addition to the fact that it is a seasonal fruit, which is why the most of trials with strawberries are carried out with freeze-dried strawberry powder.
The aim of this study is to analyze the benefits of strawberry consumption in relieving menstrual pain using the VAS (Visual Analogue Scale) scale and menstrual distress using the MEDI-Q scale, previously validated in Spanish in a previous phase of the study in female university students. The results obtained will be compared between the intervention group belonging to the intake of strawberry (specifically the "Fortuna" variety) and with a control group that will continue with their usual diet during the same period of time. They will be evaluated previously, one month and two months after receiving the intervention. The project has been approved by the Andalusian Ethics and Research Committee.
For the design of the clinical trial, previous studies on food intake and dysmenorrhea, as well as studies on the health benefits of strawberries, have been taken into account.
The "Fortuna" strawberry variety will be provided by the association Fres Huelva and must be eaten daily for a month. Participants will be provided with a menstrual diary in order to avoid forgetfulness bias. Participants who are part of the intervention group will be invited to participate in focus groups in order to know about their experiences during the trial.
Our hypothesis is that women who regularly consume strawberries in their diet will improve their pain intensity and levels of menstrual distress, as well as other symptoms associated with dysmenorrhea.
- Being tested
- Strawberry Intervention
- Keywords
- strawberry, primary dysmenorrhea, menstrual distress, pelvic pain, menstruation disturbance
- Medical subject headings
- Dysmenorrhea, Pelvic Pain, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strawberry InterventionDietary supplement
This is an intervention based on the intake of strawberry, specifically the "Fortuna" variety. This intervention is based on the intake of 250 g of fresh strawberries per day for a month. The amount and duration of strawberry intake has been consulted in other studies carried out with strawberries.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in the comparison group will not have intervention and will not receive strawberry supplements, they will follow their conventional treatment and their usual diet. They will be evaluated before the start of the intervention, one month and two months after the intervention. |
| Strawberry intervention with Fortuna variety | Experimental | This group will receive an intake of strawberries of the Fortuna variety. The participants of this group will have to eat 250 g of this strawberry variety per day for 1 month.
All participants in the intervention group will be invited to participate in focus groups once the intervention has ended, in order to learn about their experiences during it.
They will be evaluated before the start of the intervention, one month and two months after the intervention. Receives: Dietary Supplement: Strawberry Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be evaluated with the Visual Analog Scale (VAS). This is a self-administered, single-item measurement scale. Located on a horizontal or vertical line 10 cm (100mm) long, whose values range from 0 ("no pain") to 10 ("the worst pain imaginable"). Participants will be asked to write down the maximum perceived pain during the first 3 days of menstruation.
Measured: Change from baseline pain intensity at 1 month and 2 months.
Distress menstrual
Menstrual distress will be assessed using the MEDI-Q scale, which will be validated in Spanish in a previous phase of this study. This questionnaire evaluates symptoms in the premenstrual, menstrual and intermenstrual phases through a total of 25 items. The score ranges between 0 (absence of symptoms that cause distress during menstruation in the last year) and 125 (presence of all symptoms in more than half of menstruations in the last 12 months).
Measured: Change from baseline distress menstrual at 1 month and 2 months.
Secondary outcomes (9)
Changes in Quality of life
To assess quality of life, EuroQol-5D (EQ-5D) will be used. It is an element for measuring HRQoL (health-related quality of life) that measures 5 dimensions of health (mobility, personal care, usual activities, pain and discomfort and, finally, anxiety and depression). In the first part, the participant must evaluate their health status through the dimensions, the second part must evaluate their health status through a visual analog scale from 0 (worst imaginable health status) to 100 (best imaginable health status).
Measured: Baseline, 1 month and 2 months.
Anxiety State and Anxiety Trait
Anxiety will be measured through the Spanish version of the State/Trait Anxiety Inventory (STAI), made up of the Anxiety/State and Anxiety/Trait scales, with 20 items each and a Likert-type response from 0 (not at all) to 3 (very much), obtaining a total score between 0 and 60. A higher score indicates a higher level of anxiety.
Measured: Baseline, 1 month and 2 months.
Perceived well-being
Well-being will be measured with the Spanish version of the Warwick-Edinburgh Mental Well-being Scale (EBMWE). This scale consists of 14 items, with a Likert-type response option from 1 to 5. With a total score range between 14 and 70, a higher score indicates greater mental well-being.
Measured: Baseline, 1 month and 2 months.
Sleep quality
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI). It is a self-report scale to assess sleep quality divided into 7 parts with 19 items, associated in 10 questions, each of which is scored between 0 (ease) and 3 (severe difficulty). The total score ranges from 0 (ease of sleeping) to 21 (difficulty in all areas).
Measured: Baseline, 1 month and 2 months.
Changes amount of bleeding
Changes in the amount of bleeding will be measured through questions about the number of sanitary towels at day in relation to the last menstruation.
Measured: Baseline, 1 month and 2 months.
Changes menstrual issues
Menstrual issues will be assessed through questions about days of menstruation, and length of cycle (in days) in relation to the last menstruation.
Measured: Baseline, 1 month and 2 months.
Changes in menstrual pain management
Questions will be asked to know the method used to relieve menstrual pain; in the case of pharmacological pain relief, the dose and type of drug, and the effectiveness of the method will be asked.
Measured: Baseline, 1 month and 2 months.
Changes in absenteeism and presenteeism days
Absenteeism and presenteeism will be consulted, through questions regarding the number of days that absenteeism or presenteeism has occurred in relation to the last menstruation.
Measured: Baseline, 1 month and 2 months.
The impact on daily and academic activities
The impact on daily and academic activities will be evaluated with specific questions that will be answered on a scale of 0-10 (where 0 is not having a limitation and 10 is the impossibility of doing it) in relation to different situations and activities with respect to the last menstruation
Measured: Baseline, 1 month and 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start2 Apr 2024
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- 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
- Women who meet the inclusion criteria will be divided into two groups. There will be an intervention group, corresponding to the intake of strawberry and a control group. Participants will be randomly assigned to each group, the randomization will be 1:1, so there will be the same number of participants in each of the two groups. The intervention group will receive the corresponding amount of strawberries and the control group will continue with their usual diet and treatment for dysmenorrhea.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynthia del Rocío Márquez Beltrán
- Sponsor type
- University, hospital or other
- Collaborators
- University of Huelva
- Responsible party
- Sponsor-investigator, Cynthia del Rocío Márquez Beltrán, University of Huelva
- Investigators
- Elia Fernández Martínez, PHD, Study director, Teacher and Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250660
- Sponsor's protocol ID
- PFH-1123
- Status last verified
- Jul 2024
- First submitted
- 26 Jan 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armour M, Parry K, Manohar N, Holmes K, Ferfolja T, Curry C, MacMillan F, Smith CA. The Prevalence and Academic Impact of Dysmenorrhea in 21,573 Young Women: A Systematic Review and Meta-Analysis. J Womens Health (Larchmt). 2019 Aug;28(8):1161-1171. doi: 10.1089/jwh.2018.7615. Epub 2019 Jun 6.
PubMed 31170024Abreu-Sanchez A, Parra-Fernandez ML, Onieva-Zafra MD, Ramos-Pichardo JD, Fernandez-Martinez E. Type of Dysmenorrhea, Menstrual Characteristics and Symptoms in Nursing Students in Southern Spain. Healthcare (Basel). 2020 Aug 26;8(3):302. doi: 10.3390/healthcare8030302.
PubMed 32858887Cholbeigi E, Rezaienik S, Safari N, Lissack K, Griffiths MD, Alimoradi Z. Are health promoting lifestyles associated with pain intensity and menstrual distress among Iranian adolescent girls? BMC Pediatr. 2022 Oct 5;22(1):574. doi: 10.1186/s12887-022-03639-x.
PubMed 36199045Chen HM, Wang HH, Chiu MH, Hu HM. Effects of acupressure on menstrual distress and low back pain in dysmenorrheic young adult women: an experimental study. Pain Manag Nurs. 2015 Jun;16(3):188-97. doi: 10.1016/j.pmn.2014.06.002. Epub 2014 Aug 28.
PubMed 25175554Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018 Sep;219(3):255.e1-255.e20. doi: 10.1016/j.ajog.2018.04.001. Epub 2018 Apr 7.
PubMed 29630882Bajalan Z, Alimoradi Z, Moafi F. Nutrition as a Potential Factor of Primary Dysmenorrhea: A Systematic Review of Observational Studies. Gynecol Obstet Invest. 2019;84(3):209-224. doi: 10.1159/000495408. Epub 2019 Jan 10.
PubMed 30630172Cassioli E, Rossi E, Melani G, Faldi M, Rellini AH, Wyatt RB, Oester C, Vannuccini S, Petraglia F, Ricca V, Castellini G. The menstrual distress questionnaire (MEDI-Q): reliability and validity of the English version. Gynecol Endocrinol. 2023 Jun 19;39(1):2227275. doi: 10.1080/09513590.2023.2227275.
PubMed 37356456Vannuccini S, Rossi E, Cassioli E, Cirone D, Castellini G, Ricca V, Petraglia F. Menstrual Distress Questionnaire (MEDI-Q): a new tool to assess menstruation-related distress. Reprod Biomed Online. 2021 Dec;43(6):1107-1116. doi: 10.1016/j.rbmo.2021.08.029. Epub 2021 Oct 26.
PubMed 34753680Fernandez-Martinez E, Abreu-Sanchez A, Velarde-Garcia JF, Iglesias-Lopez MT, Perez-Corrales J, Palacios-Cena D. Living with Restrictions. The Perspective of Nursing Students with Primary Dysmenorrhea. Int J Environ Res Public Health. 2020 Nov 17;17(22):8527. doi: 10.3390/ijerph17228527.
PubMed 33212985Fernandez-Martinez E, Abreu-Sanchez A, Perez-Corrales J, Ruiz-Castillo J, Velarde-Garcia JF, Palacios-Cena D. Living with Pain and Looking for a Safe Environment: A Qualitative Study among Nursing Students with Dysmenorrhea. Int J Environ Res Public Health. 2020 Sep 13;17(18):6670. doi: 10.3390/ijerph17186670.
PubMed 32933209Rodrigues AC, Gala S, Neves A, Pinto C, Meirelles C, Frutuoso C, Vitor ME. [Dysmenorrhea in adolescents and young adults: prevalence, related factors and limitations in daily living]. Acta Med Port. 2011 Dec;24 Suppl 2:383-88; quiz 389-92. Epub 2011 Dec 31. Portuguese.
PubMed 22849926Vannuccini S, Clemenza S, Cassioli E, Rossi E, Castellini G, Ricca V, Petraglia F. Uterine Fibroids, Perceived Stress, and Menstrual Distress: a Key Role of Heavy Menstrual Bleeding. Reprod Sci. 2023 May;30(5):1608-1615. doi: 10.1007/s43032-022-01126-3. Epub 2022 Dec 5.
PubMed 36471219Parra-Fernandez ML, Onieva-Zafra MD, Abreu-Sanchez A, Ramos-Pichardo JD, Iglesias-Lopez MT, Fernandez-Martinez E. Management of Primary Dysmenorrhea among University Students in the South of Spain and Family Influence. Int J Environ Res Public Health. 2020 Aug 1;17(15):5570. doi: 10.3390/ijerph17155570.
PubMed 32752254Fernandez-Martinez E, Perez-Corrales J, Palacios-Cena D, Abreu-Sanchez A, Iglesias-Lopez MT, Carrasco-Garrido P, Velarde-Garcia JF. Pain management and coping strategies for primary dysmenorrhea: A qualitative study among female nursing students. Nurs Open. 2022 Jan;9(1):637-645. doi: 10.1002/nop2.1111. Epub 2021 Oct 30.
PubMed 34719126Giampieri F, Alvarez-Suarez JM, Battino M. Strawberry and human health: effects beyond antioxidant activity. J Agric Food Chem. 2014 May 7;62(18):3867-76. doi: 10.1021/jf405455n. Epub 2014 Feb 3.
PubMed 24450925
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Intervention Based on the Consumption of Fresh Strawberries From the Huelva Region on Menstrual Pain and Menstrual Distress in Young University Students
- ClinicalTrials.gov ID
- NCT06250660
- Acronym / sponsor ID
- PFH-1123
- Keywords
- strawberry, primary dysmenorrhea, menstrual distress, pelvic pain, menstruation disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cynthia del Rocío Márquez BeltránUniversity, hospital or other
- Collaborators
- University of Huelva
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 9 Feb 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 purpose of this project is to know the effectiveness of an intervention based on the consumption of fresh strawberries from the Huelva region on menstrual pain and menstrual distress in young university students with primary dysmenorrhea, compared to a control group of students.
The participants with dysmenorrhea will be divided into two groups, the assignment will be random to the intervention group with strawberry intake for a month and comparing its effect with de control group. The results of the evaluations carried out prior, to the month and 2 months of the intervention will be compared.
Detailed description
Dysmenorrhea is a prevalent problem among women of childbearing age; previous studies carried out among young university students have identified that it affects 74% of them. Dysmenorrhea can also be accompanied by the well-known menstrual distress, which has been estimated to affect between 75 and 94% of women. The symptoms included in menstrual distress are diverse, including irritability, nausea, vomiting, abdominal pain, general weakness or fatigue, among others. Dysmenorrhea and distress have a significant impact on the lives of women who suffer from it, affecting their social life, quality of life and academic and work performance.
The methods that women use to relieve dysmenorrhea are usually pharmacological, with NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and hormonal contraceptives, but these are not free of adverse effects, so more and more studies are investigating non-pharmacological methods to relieve pain. Menstrual distress is also being included as an object of study.
A healthy lifestyle has been shown to be beneficial in relieving primary dysmenorrhoea. In particular, exercise and eating at least 2 pieces of fruit per day have been identified as protective habits.
Most of the studies that evaluate food intake in women with dysmenorrhea are observational and the few clinical trials that exist are with small samples. Strawberries are rich in flavonoids and phenolic acids, giving them anti-inflammatory and antioxidant properties. Studies carried out with strawberries have shown their benefits against chronic inflammatory and cardiovascular diseases. For these reasons, it is necessary a clinical trial to evaluate the benefits of strawberry in relieving dysmenorrhea and menstrual distress.
Carrying out a clinical trial with strawberries is a challenge. Firstly, there is no consensus on the optimal dose that should be ingested to influence health biomarkers. On the other hand, the use of fresh strawberries involves a significant cost, in addition to the fact that it is a seasonal fruit, which is why the most of trials with strawberries are carried out with freeze-dried strawberry powder.
The aim of this study is to analyze the benefits of strawberry consumption in relieving menstrual pain using the VAS (Visual Analogue Scale) scale and menstrual distress using the MEDI-Q scale, previously validated in Spanish in a previous phase of the study in female university students. The results obtained will be compared between the intervention group belonging to the intake of strawberry (specifically the "Fortuna" variety) and with a control group that will continue with their usual diet during the same period of time. They will be evaluated previously, one month and two months after receiving the intervention. The project has been approved by the Andalusian Ethics and Research Committee.
For the design of the clinical trial, previous studies on food intake and dysmenorrhea, as well as studies on the health benefits of strawberries, have been taken into account.
The "Fortuna" strawberry variety will be provided by the association Fres Huelva and must be eaten daily for a month. Participants will be provided with a menstrual diary in order to avoid forgetfulness bias. Participants who are part of the intervention group will be invited to participate in focus groups in order to know about their experiences during the trial.
Our hypothesis is that women who regularly consume strawberries in their diet will improve their pain intensity and levels of menstrual distress, as well as other symptoms associated with dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women who meet the inclusion criteria will be divided into two groups. There will be an intervention group, corresponding to the intake of strawberry and a control group. Participants will be randomly assigned to each group, the randomization will be 1:1, so there will be the same number of participants in each of the two groups. The intervention group will receive the corresponding amount of strawberries and the control group will continue with their usual diet and treatment for dysmenorrhea.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in the comparison group will not have intervention and will not receive strawberry supplements, they will follow their conventional treatment and their usual diet. They will be evaluated before the start of the intervention, one month and two months after the intervention. |
| Strawberry intervention with Fortuna variety | Experimental | Dietary Supplement: Strawberry InterventionThis group will receive an intake of strawberries of the Fortuna variety. The participants of this group will have to eat 250 g of this strawberry variety per day for 1 month. All participants in the intervention group will be invited to participate in focus groups once the intervention has ended, in order to learn about their experiences during it. They will be evaluated before the start of the intervention, one month and two months after the intervention. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Nulliparous women
- Suffer menstrual pain at least 1 time in the last 6 months or 3 times in the last year
- Without a history of diagnosed gynecological pathology
- Not taking hormonal contraception
- Being enrolled at the University of Huelva for the academic year 2023/2024
Key exclusion criteria (5 listed)
- Those who do not meet the inclusion criteria
- Being in the process of mobility during the months of study
- Have had an abortion
- Suffer from a problem that requires limiting the consumption of fruit or strawberries in their diet
- Suffer from a chronic disease that causes pain
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 |
|---|---|---|
| Strawberry InterventionThis is an intervention based on the intake of strawberry, specifically the "Fortuna" variety. This intervention is based on the intake of 250 g of fresh strawberries per day for a month. The amount and duration of strawberry intake has been consulted in other studies carried out with strawberries. | Dietary supplement | Strawberry intervention with Fortuna variety |
Primary outcome
Pain intensity
Time frame: Change from baseline pain intensity at 1 month and 2 months.
Pain intensity will be evaluated with the Visual Analog Scale (VAS). This is a self-administered, single-item measurement scale. Located on a horizontal or vertical line 10 cm (100mm) long, whose values range from 0 ("no pain") to 10 ("the worst pain imaginable"). Participants will be asked to write down the maximum perceived pain during the first 3 days of menstruation.
Distress menstrual
Time frame: Change from baseline distress menstrual at 1 month and 2 months.
Menstrual distress will be assessed using the MEDI-Q scale, which will be validated in Spanish in a previous phase of this study. This questionnaire evaluates symptoms in the premenstrual, menstrual and intermenstrual phases through a total of 25 items. The score ranges between 0 (absence of symptoms that cause distress during menstruation in the last year) and 125 (presence of all symptoms in more than half of menstruations in the last 12 months).
9 secondary outcomes
Changes in Quality of life
Time frame: Baseline, 1 month and 2 months.
Anxiety State and Anxiety Trait
Time frame: Baseline, 1 month and 2 months.
Perceived well-being
Time frame: Baseline, 1 month and 2 months.
Sleep quality
Time frame: Baseline, 1 month and 2 months.
Changes amount of bleeding
Time frame: Baseline, 1 month and 2 months.
Changes menstrual issues
Time frame: Baseline, 1 month and 2 months.
Changes in menstrual pain management
Time frame: Baseline, 1 month and 2 months.
Changes in absenteeism and presenteeism days
Time frame: Baseline, 1 month and 2 months.
The impact on daily and academic activities
Time frame: Baseline, 1 month and 2 months.
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 1 Aug 2024.
- Background: PubMed 31170024Armour M, Parry K, Manohar N, Holmes K, Ferfolja T, Curry C, MacMillan F, Smith CA. The Prevalence and Academic Impact of Dysmenorrhea in 21,573 Young Women: A Systematic Review and Meta-Analysis. J Womens Health (Larchmt). 2019 Aug;28(8):1161-1171. doi: 10.1089/jwh.2018.7615. Epub 2019 Jun 6.
- Background: PubMed 32858887Abreu-Sanchez A, Parra-Fernandez ML, Onieva-Zafra MD, Ramos-Pichardo JD, Fernandez-Martinez E. Type of Dysmenorrhea, Menstrual Characteristics and Symptoms in Nursing Students in Southern Spain. Healthcare (Basel). 2020 Aug 26;8(3):302. doi: 10.3390/healthcare8030302.
- Background: PubMed 36199045Cholbeigi E, Rezaienik S, Safari N, Lissack K, Griffiths MD, Alimoradi Z. Are health promoting lifestyles associated with pain intensity and menstrual distress among Iranian adolescent girls? BMC Pediatr. 2022 Oct 5;22(1):574. doi: 10.1186/s12887-022-03639-x.
- Background: PubMed 25175554Chen HM, Wang HH, Chiu MH, Hu HM. Effects of acupressure on menstrual distress and low back pain in dysmenorrheic young adult women: an experimental study. Pain Manag Nurs. 2015 Jun;16(3):188-97. doi: 10.1016/j.pmn.2014.06.002. Epub 2014 Aug 28.
- Background: PubMed 29630882Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018 Sep;219(3):255.e1-255.e20. doi: 10.1016/j.ajog.2018.04.001. Epub 2018 Apr 7.
- Background: PubMed 30630172Bajalan Z, Alimoradi Z, Moafi F. Nutrition as a Potential Factor of Primary Dysmenorrhea: A Systematic Review of Observational Studies. Gynecol Obstet Invest. 2019;84(3):209-224. doi: 10.1159/000495408. Epub 2019 Jan 10.
- Background: PubMed 37356456Cassioli E, Rossi E, Melani G, Faldi M, Rellini AH, Wyatt RB, Oester C, Vannuccini S, Petraglia F, Ricca V, Castellini G. The menstrual distress questionnaire (MEDI-Q): reliability and validity of the English version. Gynecol Endocrinol. 2023 Jun 19;39(1):2227275. doi: 10.1080/09513590.2023.2227275.
- Background: PubMed 34753680Vannuccini S, Rossi E, Cassioli E, Cirone D, Castellini G, Ricca V, Petraglia F. Menstrual Distress Questionnaire (MEDI-Q): a new tool to assess menstruation-related distress. Reprod Biomed Online. 2021 Dec;43(6):1107-1116. doi: 10.1016/j.rbmo.2021.08.029. Epub 2021 Oct 26.
- Background: PubMed 33212985Fernandez-Martinez E, Abreu-Sanchez A, Velarde-Garcia JF, Iglesias-Lopez MT, Perez-Corrales J, Palacios-Cena D. Living with Restrictions. The Perspective of Nursing Students with Primary Dysmenorrhea. Int J Environ Res Public Health. 2020 Nov 17;17(22):8527. doi: 10.3390/ijerph17228527.
- Background: PubMed 32933209Fernandez-Martinez E, Abreu-Sanchez A, Perez-Corrales J, Ruiz-Castillo J, Velarde-Garcia JF, Palacios-Cena D. Living with Pain and Looking for a Safe Environment: A Qualitative Study among Nursing Students with Dysmenorrhea. Int J Environ Res Public Health. 2020 Sep 13;17(18):6670. doi: 10.3390/ijerph17186670.
- Background: PubMed 22849926Rodrigues AC, Gala S, Neves A, Pinto C, Meirelles C, Frutuoso C, Vitor ME. [Dysmenorrhea in adolescents and young adults: prevalence, related factors and limitations in daily living]. Acta Med Port. 2011 Dec;24 Suppl 2:383-88; quiz 389-92. Epub 2011 Dec 31. Portuguese.
- Background: PubMed 36471219Vannuccini S, Clemenza S, Cassioli E, Rossi E, Castellini G, Ricca V, Petraglia F. Uterine Fibroids, Perceived Stress, and Menstrual Distress: a Key Role of Heavy Menstrual Bleeding. Reprod Sci. 2023 May;30(5):1608-1615. doi: 10.1007/s43032-022-01126-3. Epub 2022 Dec 5.
- 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.
Elia Fernández Martínez, PHD study director
Teacher and Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strawberry Intervention in people with Primary Dysmenorrhea and Menstrual Pain, run by Cynthia del Rocío Márquez Beltrán at 1 site in Spain.
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 5 inclusion and 5 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 1 Aug 2024. 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 Spain. 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?
Pain intensity (time frame: Change from baseline pain intensity at 1 month and 2 months.). 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 NCT06250660, which also lists 27 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 1 Aug 2024.