Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

The effect of psychoeducational intervention, based on a self-regulation model on menstrual distress in adolescents: a protocol of a randomized controlled trial

Authors: Somayeh Asgari, Zainab Alimoardi, Mohammad Ali Soleimani, Kelly-Ann Allen, Nasim Bahrami

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Introduction

Menstrual distress caused by primary dysmenorrhea is associated with physical and psychological symptoms—before, after, and during menstruation. Leventhal’s self-regulation educational model is based on the cognitive and emotional experiences of threat responses to symptoms and relates to coping responses. This study aims to investigate the effect of the implementation of a psychoeducational intervention, based on the self-regulation model of menstrual distress in adolescents.

Methods/design

In this randomized controlled trial, 120 adolescent girls with moderate to severe menstrual pain (based on visual analog scale (VAS) ≥ 4) from twelve randomly selected high schools in Qazvin City will be enrolled in the study and will be randomly assigned to either a 3-session psychoeducational intervention (n = 60) or control (n = 60) groups. The sessions will be between 60 and 90 min apiece, and they will run for three consecutive weeks (one session per week). The data collection tools will include questionnaire eliciting menstrual information and demographics, the VAS, the Moos Menstrual Distress Questionnaire, and the illness perception questionnaire. One month prior to the intervention, both groups will participate in an initial assessment to assess the severity of their pain and level of menstrual distress. Finally, all questionnaires will be completed for three consecutive months after the intervention is completed.

Discussion

It is anticipated that findings of this study will provide evidence for the effectiveness of the Leventhal self-regulation model. Implications for improved practice, understanding, and treatment for menstrual distress may also arise.

Ethical considerations

The research protocol will be reviewed by the ethics committee, which is affiliated with the Qazvin University of Medical Sciences (Decree code: IR.QUMS.REC.1398.043).

Trial registration

IRCT201906250440​02N1. Registration date: 2019-09-03.
Literature
1.
Bair MJ, Robinson RL, Katon W, Kroenke K. Depression and pain comorbidity: a literature review. Arch Intern Med. 2003;163(20):2433–45.CrossRef
2.
Rapkin A. Pelvic pain and dysmenorrhea. Berek Novaks Gynecol. 2012;475:470–4.
3.
Jonathan SB, Berek B, Paoulo AB, editors. Novak’s gynecology. Maryland, library of congress cataloging; 2012.
4.
Iacovides SAI, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015;21(6):762–78.CrossRef
5.
Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36(1):104–13.CrossRef
6.
Kharaghani R, Damghanian MJIRCMJ. The prevalence of dysmenorrhea in iran: a systematic review and meta-analysis. 2017;19(3):1–10.
7.
Momenzadeh FTM, Taghizadeh M, Mahlioji M, Rafiee F. Comparison the effect of fennel and mefenamic acid on severity of primary dysmenorrhea. Iran J Obstet Gynecol Infertility. 2017;20(4):44–9.
8.
Sahin N, Kasap B, Kirli U, Yeniceri N, Topal Y. Assessment of anxiety-depression levels and perceptions of quality of life in adolescents with dysmenorrhea. Reprod Health. 2018;15(1):13.CrossRef
9.
Bajalan Z, Moafi F, MoradiBaglooei M, Alimoradi Z. Mental health and primary dysmenorrhea: a systematic review. J Psychosom Obstet Gynecol. 2019;40(3):185–94.CrossRef
10.
Omidvar S, Begum K. Menstrual pattern among unmarried women from south India. J Nat Sci Biol Med. 2011;2(2):174.CrossRef
11.
Shahr-Jerdy SHR, Eivazi M. Effects of stretching exercises on primary dysmenorrhea in adolescent girls. Biomed Hum Kinetics. 2012;4:32–127.CrossRef
12.
Chen H-M, Wang H-H, Chiu M-H, Hu H-M. Effects of acupressure on menstrual distress and low back pain in dysmenorrheic young adult women: an experimental study. Pain Manag Nurs. 2015;16(3):188–97.CrossRef
13.
Al-Kindi R, Al-Bulushi A. Prevalence and impact of dysmenorrhoea among Omani high school students. Sultan Qaboos Univ Med J. 2011;11(4):485.PubMedPubMedCentral
14.
Kordi M, Mohamadirizi S, Shakeri MT, Salehi Fadardi J, Hafizi L. The relationship between midwives’ work stress and perimenstrual distress. Iran J Obstet Gynecol Infertility. 2011;14(3):54–63.
15.
Gharloghi S, Torkzahrani S, Akbarzadeh AR, Heshmat R. The effects of acupressure on severity of primary dysmenorrhea. Patient Preference Adherence. 2012;6:137.PubMed
16.
Gagua TTB, Gagua D, McHedlishvili N. Assessment of anxiety and depression in adolescents with primary dysmenorrhea:a case-control study. J Pediatr Adolesc Gynecol. 2013;26(6):350–4.CrossRef
17.
Haidari FAA, Sarhadi M, Mohammad SM. Prevalence and severity of primary dysmenorrhea and its relation to anthropometric parameters. J Hayat. 2011;17(1):70–7.
18.
Davdabady Farahani MK, Seyyedzadeh Aghdam N. Comparison of ginger and valerian on the severity of primary dysmenorrhea: a randomized triple blind clinical trial. Complement Med J Fac Nurs Midwifery. 2013;3(2):494–503 [Persian].
19.
Kazaeeian SNA, Navabi RS. Evaluation effects of oral aloe vera gel on the intensity of primery dysmenorrhea. Med Surg Nurs Q. 2012;1(1):35–40.
20.
Rasoolzadeh NZJ, Zolphagari M, Mehran A. Effects of relaxation on primary dysmenorhea among first year nursing and midwifery female students. Hayat. 2007;13(2):2330.
21.
Hosono TTY, Morita Y, Nishimura Y, Sugita Y, Isami C. Effects of a heat-and steam-generating sheet on relieving symptoms of primary dysmenorrhea in young women. J Obstet Gynaecol Res. 2010;36(4):24–818.CrossRef
22.
DA O'Connell K, Westhoff C. Self-treatment patterns among adolescent girls with dysmenorrhea. J Pediatr Adolesc Gynecol. 2006;19(4):285–9.CrossRef
23.
Farshbaf Manei Sefat F, Abolghasemi A, Barahmand U, Hajloo N. Comparing the effectiveness of cognitive behavioral therapy and hypnosis therapy pain self-efficacy and pain severity in girls with primary dysmenorrhea. J Armaghane Danesh. 2017;22(1):87–103.
24.
Vlaeyen JWCG, Goubert L. The psychology of chronic pain and its management. Phys Ther Rev. 2007;12(3):179–88.CrossRef
25.
McSharry J, Moss-Morris R, Kendrick T. Illness perceptions and glycaemic control in diabetes: a systematic review with meta-analysis. Diabet Med. 2011;28(11):1300–10.CrossRef
26.
Rakhshan M. In: Rakhshan ME, editor. The application of the Lorentz self-governing theory in nursing. Mashhad: Young Nurses; 2014.
27.
Broadbent E, Ellis CJ, Thomas J, Gamble G, Petrie KJ. Further development of an illness perception intervention for myocardial infarction patients: a randomized controlled trial. J Psychosom Res. 2009;67(1):17–23.CrossRef
28.
Rahimi Z, Baljani S, Zadgasem Z. Investigating the relationship between illness perception and quality of life in hemodialysis patients; 2012.
29.
Abubakari AR, Jones MC, Lauder W, Kirk A, Anderson J, Devendra D. Associations between knowledge, illness perceptions, self-management and metabolic control of type 2 diabetes among African and European-origin patients. J Nurs Healthc Chronic Illn. 2011;3(3):245–56.CrossRef
30.
Cameron LD, Leventhal H. The self-regulation of health and illness behaviour. Canada and USA: Psychology Press; 2003.
31.
Holdcroft A. Gender bias in research: how does it affect evidence based medicine? London: SAGE Publications Sage UK; 2007.
32.
Wong CL, Lai KY, Tse HM. Effects of SP6 acupressure on pain and menstrual distress in young women with dysmenorrhea. Complement Ther Clin Pract. 2010;16(2):64–9.CrossRef
33.
Peng C-YJ, Harwell M, Liou S-M, Ehman LH. Advances in missing data methods and implications for educational research. Real Data Anal. 2006;3178.
34.
Zakerimoghadam M, Sadeghi-Akbari A, Cheraghi M-A, Kazemnejad A. The effect of education based on illness perception on self-care behaviors of patients with heart failure. IJCN. 2015;4(1):22–30.
35.
Kus T, Aktas G, Ekici H, Elboga G, Djamgoz S. Illness perception is a strong parameter on anxiety and depression scores in early-stage breast cancer survivors: a single-center cross-sectional study of Turkish patients. Support Care Cancer. 2017;25(11):3347–55.CrossRef
36.
Zahedifard TFM. Assessment of the articles related to primary dysmenorrhea in dimension of menstrual pain assessment tools. Iran J Obstet Gynecol Infertility. 2016;19(4):17–27.
37.
Mudgalkar N, Bele SD, Valsangkar S, Bodhare TN, Gorre MJI. Utility of numerical and visual analog scales for evaluating the post-operative pain in rural patients. Indian J Anaesth. 2012;56(6):553.
38.
Moos RH. The development of a menstrual distress questionnaire. Psychosom Med. 1968;30(6):853–67.CrossRef
39.
Qorbanalipour K, Ghaderi F, Asghari Jafarabadi M, Mohammadalizade Charandabi S. Validity and reliability of the Persian version of modified Moos Menstrual Distress Questionnaire %J The Iranian Journal of Obstetrics, Gynecol Infertility 2016;19(29):11–18.
40.
Valipoor F, Rezaei F. Assessment of Illness perception in the patients with diabetes mellitus and its association with control of blood sugar in the patients referring to Tohid Hospital in Sanandaj city. HBI J. 2013;18(2):9–17.
41.
Rasbash J, Steele F, Browne W, Goldstein H, Charlton C, Browne W. A user’s guide to MLwiN, v2. 26. centre for multilevel modelling. UK: University of Bristol; 2012.
42.
Yang N-Y, Kim S-DJTJA, Medicine C. Effects of a yoga program on menstrual cramps and menstrual distress in undergraduate students with primary dysmenorrhea: a single-blind, randomized controlled trial. 2016;22(9):732–8.
43.
Bazzazian S, Besharat MA. Reliability and validity of a Farsi version of the brief illness perception questionnaire. Procedia Soc Behav Sci. 2010;5:962–5.CrossRef
44.
Kabirian A, Abedian Z, Mazloum SR, Kabirian MJJTHUMS. The effect of self-care behaviors based on evidence-based education on the severity of dysmenorrhea amongst girls. 2017;5(1):26–31.
45.
Morgan K, Villiers-Tuthill A, Barker M, McGee H. The contribution of illness perception to psychological distress in heart failure patients. BMC Psychol. 2014;2(1):50.CrossRef
46.
Timmermans I, Versteeg H, Meine M, Pedersen S, Denollet J. Illness perceptions in patients with heart failure and an implantable cardioverter defibrillator: dimensional structure, validity, and correlates of the brief illness perception questionnaire in Dutch, French and German patients. J Psychosom Res. 2017;97:1–8.CrossRef
Metadata
Title
The effect of psychoeducational intervention, based on a self-regulation model on menstrual distress in adolescents: a protocol of a randomized controlled trial
Authors
Somayeh Asgari
Zainab Alimoardi
Mohammad Ali Soleimani
Kelly-Ann Allen
Nasim Bahrami
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04629-z

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue

Methodology

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial

Study protocol

Anterior quadratus lumborum block for postoperative recovery after total hip arthroplasty: a study protocol for a single-center, double-blind, randomized controlled trial

Study protocol

Efficacy and safety of Guhong injection for treating coronary microvascular disease: study protocol for a randomized controlled trial

Study protocol

Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial

Study protocol

An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial

Study protocol

Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial