The Effects of Whole Body Prenatal Massage Therapy During Pregnancy: A Randomized Controlled Experimental Trial
NCT ID: NCT05007210
Last Updated: 2021-08-16
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-10-24
2017-11-08
Brief Summary
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Aim: The study aimed to determine the effect of massage therapy during pregnancy on women and their fetuses in a university hospital in Izmir, Turkey.
Method: A randomized controlled experimental trial was aimed to reach primipara pregnant women, 20-35 years old, who came to a university obstetric clinic to get the results of the first-trimester screen test. Researchers aimed to reach 30 pregnant women at the start of the study. Participants were randomly allocated to a parallel comparison group by a central office. The sampling technique has been applied according to the CONSORT criteria.
The study practices have been carried out after receiving ethics committee and institution approvals after the researcher completed the prenatal massage therapy training, and after taking the voluntary informed consent of the pregnant women. The practices have been carried out in the massage office that was formed within the scope of the study. Electronic fetal monitoring (EFM), BPP, vital signs, fetal heart rate (FHR) evaluation have been carried out for the pregnants whose routine gestational monitoring went on during their gestational week between the 30th and 34th in the control group, and Pregnant Description Form, VAS, Prenatal Attachment Inventory-PAI, Revised Prenatal Distress Questionnaire-PDQ have been applied. In the prenatal massage therapy group, between the 30th and 34th weeks, each week for five weeks, prenatal massage therapy including a 60 minutes deep tissue and Sweden massage methods had been applied once a week. Side-Lying Positioning System that is designed specifically for the pregnant has been used during the practices. In addition, the reason why the study group consisted of pregnant women in these weeks; Perinatology specialists recommend women to experience a deep and sustainable level of relaxation for 45-60 minutes before falling asleep, especially in the last 6-8 weeks of pregnancy, in preparation for labour (Osborne et al. 2021). In line with this suggestion, since the whole body massage has been performed in the research method, a 60-minute massage (30 minutes for each lateral position) has been applied.
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Detailed Description
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Method: The study was a randomized controlled experimental trial carried out with 20-35 years-old primipara pregnant women who came to obstetrics polyclinic of a university for evaluation of their first-trimester screen test's results, had no infertility story and were not at high risk (inclusion criteria). The participants were randomly allocated to the parallel comparison groups by a central office. The sample selection process in the study has been planned to be applied according to the CONSORT criteria (Moher et al. 2010) and the permutation method with blocked randomization has been done to the records assigned from the centre that the study was applied (Kanık, Tasdelen, and Erdogan 2011). In the process of collecting data, one blinding method has been applied, and it has only been applied to data analysis. Researchers aimed to reach 30 pregnant women at the start of the study. The completion decision of the data gathering process has been determined with power analysis that is carried out by the PASS program.
The study practices have been carried out after receiving ethics committee and institution approvals after the researcher completed the prenatal massage therapy training, and after taking the voluntary informed consent of the pregnant women. The practices have been carried out in the massage office that was formed within the scope of the study. Electronic fetal monitoring (EFM), BPP, vital signs, fetal heart rate (FHR) evaluation have been carried out for the pregnants whose routine gestational monitoring went on during their gestational week between the 30th and 34th in the control group, and Pregnant Description Form, VAS, Prenatal Attachment Inventory-PAI, Revised Prenatal Distress Questionnaire-PDQ have been applied. In the prenatal massage therapy group, between the 30th and 34th weeks, each week for five weeks, prenatal massage therapy including a 60 minutes deep tissue and Sweden massage methods had been applied once a week. Side-Lying Positioning System that is designed specifically for the pregnant has been used during the practices. In addition, the reason why the study group consisted of pregnant women in these weeks; Perinatology specialists recommend women to experience a deep and sustainable level of relaxation for 45-60 minutes before falling asleep, especially in the last 6-8 weeks of pregnancy, in preparation for labour (Osborne et al. 2021). In line with this suggestion, since the whole body massage has been performed in the research method, a 60-minute massage (30 minutes for each lateral position) has been applied.
Like before the prenatal massage therapy on the first date and after the prenatal massage therapy on the last date in the control group, all the forms and measurements have been applied. Pregnant women's VAS was measured before and after the prenatal massage therapy and the evaluation of the other measured data have been held between the 31st and 33rd gestational weeks. Also, Visual Analog Patient Satisfaction Scale-VAPSS has been measured after each prenatal massage therapy for finding satisfaction levels. In the process of the study, any significant side effect related to the practices hasn't occurred. The completion decision of the data gathering process has been determined with power analysis that was carried out by PASS program. The analysis of the study data has been carried out through SPSS 16 program.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Prenatal massage therapy group
Prenatal massage therapy for prenatal attachment, physiological and psychological distress, maternal and fetal well-being.
Prenatal massage therapy
Pregnant women in the intervention group had a whole body prenatal massage therapy every week between 30th and 34th gestational weeks (once a week, 5-weeks in total and 60-minutes each).Session content for the prenatal massage therapy group was created by the researcher who was 640-hours trained massaging midwife.It included 12 different massage techniques (Osborne 2015, Osborne 2021).Also, the session, which included deep tissue and Sweden massage methods, had been applied.Each session began with the pregnant woman in a side-lying position with standart special pillows (30-minutes for left, 30-minutes for right).EFM, BPP, vital signs, FHR evaluation were carried out for all participants per visiting the hospital for the study.BPP before and after prenatal massage therapy was evaluated by an obstetrician.A phone number was set for the study, and this phone number was used by the massaging midwife.The service has been provided for pregnant women to reach her whenever they want.
Control group
Pregnant women in the control group were interviewed twice (once a week for 30th and 34th week) by the same massaging midwife. No additional attempt was made except for filling out the forms and evaluating the biophysical profile by the obstetrician in these interviews. The massaging midwife's phone number was given to the pregnant women in both groups if they want to reach anytime. A phone number was set for the study, and this phone number was used by the massaging midwife. This service has been provided for pregnant women to reach her whenever they want.
No interventions assigned to this group
Interventions
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Prenatal massage therapy
Pregnant women in the intervention group had a whole body prenatal massage therapy every week between 30th and 34th gestational weeks (once a week, 5-weeks in total and 60-minutes each).Session content for the prenatal massage therapy group was created by the researcher who was 640-hours trained massaging midwife.It included 12 different massage techniques (Osborne 2015, Osborne 2021).Also, the session, which included deep tissue and Sweden massage methods, had been applied.Each session began with the pregnant woman in a side-lying position with standart special pillows (30-minutes for left, 30-minutes for right).EFM, BPP, vital signs, FHR evaluation were carried out for all participants per visiting the hospital for the study.BPP before and after prenatal massage therapy was evaluated by an obstetrician.A phone number was set for the study, and this phone number was used by the massaging midwife.The service has been provided for pregnant women to reach her whenever they want.
Eligibility Criteria
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Inclusion Criteria
* Primiparous women
* Low-risk pregnant women
* Before the 30th week of gestation Also for the group of the prenatal massage therapy;
* Can come 5 times for each week of gestation between 30 and 34 weeks
* No infectious disease or skin infection on the skin,
* No thrombosis or phlebitis
* Single and healthy fetus
* Written and verbally available
* Before the 30th week of gestation
* Accept attendance
* Residing in the province in which the study conducted city
Exclusion Criteria
* High risk pregnancy
* Live or stillbirth after 20th week of gestation
* Abortion after the first trimester
* History of recurrent pregnancy loss
20 Years
35 Years
FEMALE
Yes
Sponsors
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Ege University
OTHER
Responsible Party
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Yeliz CAKIR KOCAK
Midwifery Research Asistant
Locations
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Yeliz Çakır Koçak
Izmir, Bornova, Turkey (Türkiye)
Countries
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References
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Alp Dal, N., & Ertem, G. (2016). Fetal Sağlığın Değerlendirilmesi ve Tarama Testleri. In Ü. Sevil & G. Ertem (Eds.), Perinatoloji ve Bakım (Birinci ba, pp. 373-408). Ankara Nobel Tıp Kitabevleri.
Clarke, M. (1964). Reliability and sensibility in the self-assessment of well-being. Bul Br Psy Soc, 17(18A).
Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available.
Dereli Yilmaz, S., & Kızılkaya Beji, N. (2013). Prenatal Bağlanma Envanterinin Türkçe'ye Uyarlanması: Güvenilirlik ve Geçerlilik Çalışması. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 16(2), 103-109.
Eti Aslan, F. (2004). Ameliyat Sonrası Ağrı Değerlendirmesinde Görsel Kıyaslama Ölçeğiyle Basit Tanımlayıcı Ölçeğin Duyarlık ve Seçiciliği. Yoğun Bakım Hemşireliği Dergisi, 8(1), 1-6. http://dergipark.gov.tr/ybhd/issue/26499/278822
Hayes, M. H. S., & Patterson, D. G. (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99.
Ibrahim SM, Lobel M. Conceptualization, measurement, and effects of pregnancy-specific stress: review of research using the original and revised Prenatal Distress Questionnaire. J Behav Med. 2020 Feb;43(1):16-33. doi: 10.1007/s10865-019-00068-7. Epub 2019 Jun 10.
Kanık, E. A., Tasdelen, B., & Erdogan, S. (2011). Randomization In Clinical Trials. Marmara Medical Journal, 24, 149-155. https://doi.org/10.5472/MMJ.2011.01981.1
Kılınçer, C., & Zileli, M. (2006). Görsel Analog Hasta Tatmini Skalası. Trakya Univ Tip Fak Derg, 23(3), 113-118.
Lobel M, Cannella DL, Graham JE, DeVincent C, Schneider J, Meyer BA. Pregnancy-specific stress, prenatal health behaviors, and birth outcomes. Health Psychol. 2008 Sep;27(5):604-15. doi: 10.1037/a0013242.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
Muller ME. Development of the Prenatal Attachment Inventory. West J Nurs Res. 1993 Apr;15(2):199-211; discussion 211-5. doi: 10.1177/019394599301500205. No abstract available.
Osborne, C. (2015). Pre- and Perinatal Massage Therapy Certification Workshop Student Guide (Special Document).
Yali AM, Lobel M. Coping and distress in pregnancy: an investigation of medically high risk women. J Psychosom Obstet Gynaecol. 1999 Mar;20(1):39-52. doi: 10.3109/01674829909075575.
Yüksel, F., Akın, S., & Durna, Z. (2011). "Prenatal Distres Ölçeği"nin Türkçe'ye Uyarlanması ve Faktör Analizi. Hemşirelikte Eğitim ve Araştırma Dergisi, 8(3), 43-51.
Osborne, C., Kolakowski, M., & Lobenstine, D. M. (2021). Pre- and Perinatal Massage Therapy (M. Law & W. Lee (eds.); Third edit). Handspring Publishing Limited. https://www.handspringpublishing.com/product/pre-and-perinatal-massage-third-edition/
Other Identifiers
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16-ASYO-017
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Yeliz Çakır Koçak
Identifier Type: -
Identifier Source: org_study_id
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