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
  1. Rezaei-Ghaleh N, Siadat F, Azizi F. Quantitative and qualitative assessment of Iranian biomedical publications in international journals between 1992 and 2002 according to their Impact Factor. Res Med 2003; 27(2):139-43. 
  2. International Committee of Medical Journal Editors (ICMJE). International Committee of Medical Journal Editors (ICMJE): uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Haematologica 2004; 89(3):264.
  3. Sharifi V. Qualitative research evaluation. Adv Cognitive Sci 2005; 5(4):92-4. (Persian).
  4. Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol 2004; 183(6):1539-44.
  5. O’brien KD, Wright JL, Mandall NA. How to … do a randomized controlled trial. J Orthod 2003; 30(4):337-41.
  6. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux P, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010; 63(8):e1-37.
  7. O'Donnell CA. Attitudes and knowledge of primary care professionals towards evidence-based practice: a postal survey. J Eval Clin Pract 2004; 10(2):197-205.
  8. Ranae F. Reasons for choosing cesarean among women referred to bea’sat hospital of Sanandaj. J Kermanshah Univ Med Sci 2006; 10(3):277-86. (Persian).
  9. Chang MY, Wang SY, Chen CH. Effects of massage on pain and anxiety during labor: a randomized controlled trial in Taiwan. J Adv Nurs 2002; 38(1):68-73.
  10. Abushaikha L, Oweis A. Labour pain experience and intensity: a Jordanian perspective. Int J Nurs Pract 2005; 11(1):33-8.
  11. Roberts CL, Raynes-Greenow CH, Nassar N, Trevena L, McCaffery K. Protocol for a randomized controlled trial of a decision aid for the management of pain in labor and childbirth [ISRCTN52287533]. BMC Pregnancy Chilsbirth 2004; 4(1):24.
  12. Safdari Dehcheshmaei F, Delaram M, Salehian T, Moradi MT, Rahimi Madiseh M, Aliakbari F. Relief of labor pain by ice massage of the hand. Zahedan J Res Med Sci 2009; 11(1):23-9. (Persian).
  13. Fraser J, Rose KJ. Psychological effects of back massage in elderly institionalised patients. J Adv Nurs 1995; 18(2):238-45.
  14. Field TM. Massage therapy effects. Am Psychol 1997; 53(12):1270-81.
  15. Alellagen S, Wijma B, Lundberg U, Wijma K. Fear, pain and stress hormones during childbirth. J Psychosom Obstet Gynacol 2005; 26(3):153-65.
  16. Sereshti M, Asefi F, Shabanian M, Banaeian S. Comparing the effects of massage and intra intramuscular pethidine on pain relief in the stages of labor and the length of labor. Iran J Obstet Gynecol Infertil 2013; 16(80):6-16. (Persain).
  17. Enjezab B, Khoshbin A, Bokaei M, Naghshin N. Effect of ice massage on Hoku point for reduction of labor pain. Shahid Sadoughi Univ J 2008; 15(4):69-74. (Persain).
  18. Khavandizadeh Aghdam S, Adib A, Kazemzedeh R. The effects of massage during labor on pain and length of delivery in nulliparous women. Iran J Obstet Gynecol Infertil 2014; 16(83):15-20. (Persain).
  19. Pilevarzadeh M, Salari S, Shafiei N. Effect of massage on reducing pain and anxiety during labour. J Reprod Infertil 2002; 3(4):42-6.
  20. Safarzadeh A. Effect of massage on labor pain in nulliparous women. J Shahrekord Univ Med Sci 2006; 9(4):20-5. (Persian).
  21. Kaviani M, Ashoori M, Azima S, Rajaei Fard AR, Hadian Fard MJ. Comparing the effect of two methods of acupressure and ice massage on the pain, anxiety levels and labor length in the point LI-4. Shahid Sadoughi Univ J 2012; 20(2):220-8. (Persian).
  22. Foroud A, Mehdipour S. The effects of breathing patterns and massage on the pain and perception of labor in primiparous women. J Shahrekord Univ Med Sci 2006; 7:70-7. (Persian).
  23. Jenabi E, Hajiloo MM, Torkamani M. The effect of reflexology on relieving the labor pain. Iran J Obstet Gynecol Infertil 2012; 14(8):8-34. (Persian).
  24. Askari M, Alavi A, Dashtinezhad E. Effect of back massage with sesames oil on pain and length of delivery in primiparous women. Iran J Obstet Gynecol Infertil 2016; 18(183):9-12. (Persian).
  25. Safdari Dehcheshmeh F, Delaram M, Salehian T, Moradi MT, Rahimi Madiseh M, Aliakbari F. Relief of labor pain by ice massage of the hand. Zahedan J Res Med Sci 2009; 11(1):23-30.
  26. Kamali S, Jafari E, Mazloomzadeh S. The effect of ice massage of the LI4 point on severity of labor pain in primigravidas. Qom Univ Med Sci J 2015; 8(6):61-5.
  27. Hosseini SE, Asadi N, Zareei F. Investigating the effect of massage therapy on labor in the active stage of first labor. Iran J Nurs Res 2014; 9(1):25-32. (Persian).
  28. Hashemi ZS, Badakhsh M, Shahdadi H, Heydari M, Hashemi NS. The effect of massage on intensity and duration of labor pain in primigravida women in Zabol Amiralmoemenin hospital. J Rostamineh 2012; 4(1):85-93. (Persian).
  29. Abbasi Z, Abedian Z, Fadaei A, Esmaeili HE. The effects of back massage on pain intensity during the first stage of labor in primiparous women. Iran J Obstet Gynecol Infertil 2009; 11(4):39-47. (Persian).
  30. Afzali M, Ebadi A, Haj Amini Z. Study the effect of ice massage on labor pain in parturient women who reffered to allocated hospitals in Tehran city. Ebnesina 2011; 14(1):17-22. (Persian).
  31. Kaviani M, Gholami Z, Azima S, Abbasnia K, Rajaifard A. The comparison of superficial and vibration massages on backache during labor in primiparous women. Iran J Obstet Gynecol Infertil 2011; 14(5):24-50. (Persian).
  32. Hajiamini Z, Masoud SN, Ebadi A, Mahboubh A, Matin AA. Comparing the effects of ice massage and acupressure on labor pain reduction. Complement Ther Clin Pract 2012; 18(3):169-72.
  33. Mohammadkhani Shahri L, Abbaspoor Z, Aghel N, Mohammadkhani Shahri H. Effect of massage aromatherapy with lavender oil on pain intensity of active phase of labor in nulliparous women. J Med Plants 2012; 2(42):167-76.
  34. Kamalifard M, Shahnazi M, Sayyah Melli M, Allahverdizadeh S, Toraby S, Ghahvechi A. The efficacy of massage therapy and breathing techniques on pain intensity and physiological responses to labor pain. J Caring Sci 2012; 1(2):73-8.
  35. Sh TZ, Honarjoo M, Sh J, Alavi H. The effect of massage on intensity of pain during first stage of labor. Res Med 2008; 32(2):141-5.
  36. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Clin Oral Investig 2003; 7(1):2-7.
  37. Nouri S, Ghanei M. Familiarity with consolidated standards in reporting Trials (Consort). Iran J Surg 2014; 22(2):88-103. (Persian).
  38. Falagas ME, Grigori T, Ioannidou E. A systematic review of trends in the methodological quality of randomized controlled trials in various research fields. J Clin Epidemiol 2009; 62(3):227-31.
  39. Ghojazadeh M, Tavana NN, Karkhane M, Behzad M, Aghdash S. Quality of randomized clinical trial reports published by Iranian researchers in the obstetrics and gynecology level 1 journals: using consort. Iran J Obstet Gynecol Infertil 2013; 16(78):7-15. (Persian).
  40. He J, Du L, Liu G, Fu J, He X, Yu J, et al. Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews. Trials 2011; 12:122.
  41. Chao AS, Chao A, Wang TH, Chang YC, Peng HH, Chang SD, et al. Pain relief by applying transcutaneous electrical nerve stimulation (TENS) on acupuncture points during the first stage of labor: a randomized double-blind placebo-controlled trial. Pain 2007; 127(3):214-20.
  42. McCrea BH, Wright ME. Satisfaction in childbirth and perceptions of personal control in pain relief during labour. J Adv Nurs 1999; 29(4):877-84.
  43. Hodnett ED. Pain and women's satisfaction with the experience of childbirth: a systematic review. Am J Obstet Gynecol 2002; 186(5):S160-72.
  44. Irani M, Kordi M, Tara F, Bahrami HR, Nejad KS. The effect of hand and foot massage on pain and anxiety. Avicenna J Phytomed 2015; 5:63.
  45. Redmond CK, Colton T. Biostatistics in clinical trials. New Jersey: John Wiley & Sons; 2001.
  46. Moher D, Jones A, Lepage L. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 2001; 285(15):1992-5.
  47. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006; 185(5):263-7.
  48. Joukar F, Heidarzadeh A, Asgharnezhad M, Soltanipour S, Jalali MM, Moradi M. Evaluation of clinical trial abstracts of scientific journal using the CONSORT checklist. J Guilan Univ Med Sci 2015; 24(95):40-51.
  49. Ntala C, Birmpili P, Worth A, Anderson NH, Sheikh A. The quality of reporting of randomised controlled trials in asthma: systematic review protocol. Prim Care Respir J 2013; 22(1):PS1-8.
  50. Ayat Elahi SM, Jafari P, Ghaem H. An evaluation of the quality of published clinical trials in Iranian medical journals during 2001-2004. J Babol Univ Med Sci 2005; 7(4):64-70.
  51. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. New Engl J Med 1987; 317(7):426-32.
  52. Ayatollahi SM, Mohammadi M, Jafary P, Khademi A. Statistics in international medical journals of Iran. Med J Islamic Repub Iran 2002; 16(1):59-61. (Persian).
  53. Moher D, Soeken K, Sampson M, Ben-Porat L, Berman B. Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine. BMC Pediatr 2002; 2:3.
  54. Moradi MT, Asadi-Samani M, Mobasheri M. Evaluating the quality of materials and methods for writings of final proposal in clinical trial studies in Shahrekord University of Medical Sciences based on consort checklist. J Clin Nurs Midwifery 2014; 2(4):1-7. (Persian).
  55. Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials 2004; 25(2):143-56.
  56. Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006; 144(5):364-7.
  57. Wang P, Xu Q, Sun Q, Fan FF, Guo XR, Guo F. Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional Chinese medicine: a systematic review. PLoS One 2013; 8(7):e70586.
Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010; 340:c723