The Effectiveness of an Intervention of Fresh Strawberries on Menstrual Pain and Menstrual Distress

NCT06250660 | Completed

• 1 other identifier: PFH-1123
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Primary Dysmenorrhea; Menstrual Pain; Menstrual Distress \(Dysmenorrhea\)

Keywords

strawberry; primary dysmenorrhea; menstrual distress; pelvic pain; menstruation disturbance

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Change from baseline distress menstrual at 1 month and 2 months.

Secondary Outcomes (9)

• Changes in Quality of life

  Baseline, 1 month and 2 months.

• Anxiety State and Anxiety Trait

  Baseline, 1 month and 2 months.

• Perceived well-being

  Baseline, 1 month and 2 months.

• Sleep quality

  Baseline, 1 month and 2 months.

• Changes amount of bleeding

  Baseline, 1 month and 2 months.

Study Arms (2)

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.

Dietary Supplement: Strawberry Intervention

Interventions

Strawberry Intervention DIETARY_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.

Strawberry intervention with Fortuna variety

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cynthia del Rocío Márquez Beltrán: lead
• University of Huelva: collaborator

Study Sites (1)

Universidad de Huelva

Huelva, 21071, Spain

Location

Related Publications (26)

• 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.

  PMID: 31170024 BACKGROUND

• Abreu-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.

  PMID: 32858887 BACKGROUND

• Cholbeigi 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.

  PMID: 36199045 BACKGROUND

• Chen 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.

  PMID: 25175554 BACKGROUND

• Matthewman 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.

  PMID: 29630882 BACKGROUND

• Bajalan 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.

  PMID: 30630172 BACKGROUND

• Cassioli 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.

  PMID: 37356456 BACKGROUND

• Vannuccini 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.

  PMID: 34753680 BACKGROUND

• Fernandez-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.

  PMID: 33212985 BACKGROUND

• Fernandez-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.

  PMID: 32933209 BACKGROUND

• Rodrigues 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.

  PMID: 22849926 BACKGROUND

• Vannuccini 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.

  PMID: 36471219 BACKGROUND

• Parra-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.

  PMID: 32752254 BACKGROUND

• Fernandez-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.

  PMID: 34719126 BACKGROUND

• Giampieri 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.

  PMID: 24450925 BACKGROUND

• Huang L, Xiao D, Zhang X, Sandhu AK, Chandra P, Kay C, Edirisinghe I, Burton-Freeman B. Strawberry Consumption, Cardiometabolic Risk Factors, and Vascular Function: A Randomized Controlled Trial in Adults with Moderate Hypercholesterolemia. J Nutr. 2021 Jun 1;151(6):1517-1526. doi: 10.1093/jn/nxab034.

  PMID: 33758944 BACKGROUND

• O'Doherty AF, Jones HS, Sathyapalan T, Ingle L, Carroll S. The Effects of Acute Interval Exercise and Strawberry Intake on Postprandial Lipemia. Med Sci Sports Exerc. 2017 Nov;49(11):2315-2323. doi: 10.1249/MSS.0000000000001341.

  PMID: 29045326 BACKGROUND

• Ezzat-Zadeh Z, Henning SM, Yang J, Woo SL, Lee RP, Huang J, Thames G, Gilbuena I, Tseng CH, Heber D, Li Z. California strawberry consumption increased the abundance of gut microorganisms related to lean body weight, health and longevity in healthy subjects. Nutr Res. 2021 Jan;85:60-70. doi: 10.1016/j.nutres.2020.12.006. Epub 2020 Dec 5.

  PMID: 33450667 BACKGROUND

• Nikkhah S, Dolatian M, Naghii MR, Zaeri F, Taheri SM. Effects of boron supplementation on the severity and duration of pain in primary dysmenorrhea. Complement Ther Clin Pract. 2015 May;21(2):79-83. doi: 10.1016/j.ctcp.2015.03.005. Epub 2015 Apr 4.

  PMID: 25906949 BACKGROUND

• Herdman M, Badia X, Berra S. [EuroQol-5D: a simple alternative for measuring health-related quality of life in primary care]. Aten Primaria. 2001 Oct 15;28(6):425-30. doi: 10.1016/s0212-6567(01)70406-4. No abstract available. Spanish.

  PMID: 11602124 BACKGROUND

• Guillen-Riquelme A, Buela-Casal G. [Psychometric revision and differential item functioning in the State Trait Anxiety Inventory (STAI)]. Psicothema. 2011 Aug;23(3):510-5. Spanish.

  PMID: 21774907 BACKGROUND

• Spielberger CD, Gorsuch RL, Lushene RE. Cuestionario de ansiedad estado-rasgo. Madrid: Tea. 1982;1.

  BACKGROUND

• Lopez MA, Gabilondo A, Codony M, Garcia-Forero C, Vilagut G, Castellvi P, Ferrer M, Alonso J. Adaptation into Spanish of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) and preliminary validation in a student sample. Qual Life Res. 2013 Jun;22(5):1099-104. doi: 10.1007/s11136-012-0238-z. Epub 2012 Jul 27.

  PMID: 22836376 BACKGROUND

• Castellvi P, Forero CG, Codony M, Vilagut G, Brugulat P, Medina A, Gabilondo A, Mompart A, Colom J, Tresserras R, Ferrer M, Stewart-Brown S, Alonso J. The Spanish version of the Warwick-Edinburgh mental well-being scale (WEMWBS) is valid for use in the general population. Qual Life Res. 2014 Apr;23(3):857-68. doi: 10.1007/s11136-013-0513-7. Epub 2013 Sep 5.

  PMID: 24005886 BACKGROUND

• Royuela Rico A, Macías Fernández JA. Propiedades clinimetricas de la versión castellana del cuestionario de Pittsburgh. Vigilia-Sueño [Internet]. 1997;9(2):81-94. Available from: https://www.researchgate.net/publication/258705863

  BACKGROUND

• Miller K, Feucht W, Schmid M. Bioactive Compounds of Strawberry and Blueberry and Their Potential Health Effects Based on Human Intervention Studies: A Brief Overview. Nutrients. 2019 Jul 2;11(7):1510. doi: 10.3390/nu11071510.

  PMID: 31269727 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Pelvic Pain; Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Elia Fernández Martínez, PHD

  Teacher and Researcher

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The assignment to each group will be blind. It will be done through a computer application, which assigns random numbers to each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD Student. Associate researcher. Nurse.

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 9, 2024
• Study Start: April 2, 2024
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)