ارزیابی کیفیت کارآزماییهای بالینی انجام شده در رابطه با تأثیر ماساژ بر شدت درد زایمان با استفاده از معیارهای CONSORT

نوع مقاله : مروری

نویسندگان

1 دانشجوی دکترای تخصصی بهداشت باروری، کمیته تحقیقات دانشجویی، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

2 دانشیار بهداشت باروری، مرکز تحقیقات مراقبت مبتنی بر شواهد، دانشگاه علوم پزشکی مشهد، مشهد، ایران. دانشیار بهداشت باروری، گروه مامایی، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران

چکیده

مقدمه: مطالعات کارآزمایی بالینی شاهددار ­تصادفی، یکی از مهم‌ترین و کارآمدترین مطالعات در علوم پزشکی می‌باشند. به علت اهمیت این نوع مطالعات در تولید شواهد معتبر علمی در رابطه با سلامت مادران، مطالعه حاضر با هدف ارزیابی کیفیت گزارش کارآزمایی­های بالینی منتشر شده در رابطه با تأثیر ماساژ بر شدت درد زایمان توسط پژوهشگران ایرانی و با استفاده از معیارهای CONSORT طراحی و انجام شد.
روش­کار: در این مطالعه توصیفی، مقالات کارآزمایی بالینی منتشر شده در رابطه با تأثیر ماساژ بر شدت درد زایمان در مجلات فارسی و انگلیسی زبان نمایه شده در SID، IranMedx، IRANDOC، Magiran، PubMed، Scopus، CINAHL و Google scholar با استفاده از کلید واژه­های درد زایمان، ماساژ، کارآزمایی بالینی در فاصله سال­های 96-1384 بررسی شدند. از تعداد کل 155 مقاله، 20 مقاله با استفاده از ابزار Consort 2010 مورد ارزیابی قرار گرفتند. بیشترین و کمترین امتیازی که هر مقاله می‌توانست به‌دست آورد 37 و صفر بود. تجزیه و تحلیل داده­ها با استفاده از روش­های آمار توصیفی و نرم‌افزار آماری SPSS (نسخه 14) انجام شد.
یافته­ها: بر اساس نتایج ارزیابی 20 مقاله در زمینه تأثیر ماساژ بر شدت درد زایمان، میزان انطباق کلی کیفیت مقالات مورد بررسی با معیارهای گزارش Consort، 54% برآورد شد. در مجموع، بیشترین نقص در قسمت مواد و روش­ها بود و از آیتم­های این قسمت، بیشترین نواقص در تعیین حجم نمونه، روش به کار رفته برای تخصیص تصادفی شرکت کنندگان در مطالعه و نحوه کورسازی و انجام آن بود. میانگین کلی نمرات مقالات 18/3±15/20 از حداقل و حداکثر 27-12 بود. بیشترین درصد نواقص گزارش شده مرتبط با بخش مواد و روش ها به میزان 42% تخمین زده شد.
نتیجه­گیری: بیشترین ضعف پژوهشگران در گزارش نتایج مطالعات، در قسمت مواد و روش­ها می‌باشد که می‌توان با آموزش بیشتر این مباحث، استفاده از متخصصین آمار و متدولوژی و همچنین استفاده از ابزارهای استاندارد برای خودارزیابی مقالات، این موارد را برطرف نمود.

کلیدواژه‌ها

عنوان مقاله [English]

Assessing the Quality of randomized controlled trials published in relation to the Efficacy of Massage Therapy on Labor Pain Intensity Using CONSORT criteria

نویسندگان [English]

  • Morvarid Irani 1
  • Nahid Maleki 1
  • Robab Latifnejad Roudsari 2
1 PhD. Student in Reproductive Health, Student Research Committee, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Associate Professor in Reproductive Health, Evidence-Based Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Associate Professor in Reproductive Health, Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran
چکیده [English]

Introduction: Randomized controlled trials are critical and important studies in medical sciences. Due to the vital role of such studies in production of valid scientific evidence in the promotion of maternal health, this study was performed with aim to assess the quality of clinical trials in relation to the efficacy of massage therapy on labor pain intensity published by Iranian authors using CONSORT criteria.
Methods: In this descriptive study, published Randomized Controlled Trials (RCTs) in relation to the efficacy of massage therapy on labor pain intensity were evaluated in Persian and English journals which are indexed in Google scholar, PubMed, Scopus, CINAHL as well as Persian databases such as SID, IranMedx, IRANDOC, and Magiran using the keywords of labor pain, massage, and randomized clinical trials from 1995 to 2017. Out of 155 articles, 20 RCTs were assessed using CONSORT, 2010 checklist. The minimum and maximum score of the checklist was zero and 37, respectively. Data were analyzed using descriptive statistical tests with SPSS software (version 14).
Results: Based on the results of 20 selected articles about the effect of massage therapy on labor pain intensity, the overall accordance of the RCTs with CONSORT criteria was 54%. Totally, the highest defect was related to the section of methods and materials; in the items of this section, the highest defect was related to sample size, method used for randomized allocation and the method of blinding. The mean overall score of articles was 20.15±3.18 in the minimum and maximum range of 12-27. The highest percentage of reporting quality criteria was related to the methodology section, which was estimated to be 42%.
Conclusion: The most common weakness of authors in reporting the results of RCTs was seen in the section of materials and methods which could be improved by more training of these issues, use of statistics and methodology specialists and also using of standard tools for self-evaluation of the articles.

کلیدواژه‌ها [English]

  • CONSORT
  • Critical appraisal
  • Iran
  • Labor pain
  • Massage
  • Randomized controlled trial

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مجله زنان، مامایی و نازایی ایران
دوره 20، ویژه نامه
آذر 1396
صفحه 56-67

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