The Effects of Whole Body Prenatal Massage Therapy During Pregnancy: A Randomized Controlled Experimental Trial
Condition: Massage Therapy; Pregnancy Related; Fetus Fetus
Study type: Interventional

Summary: 
      Background: Massage therapy in many parts of the world is used in all periods of pregnancy.

      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.
    

Detailed description: 
      Aim: The study aims to determine the effect of massage during pregnancy on women and their
      fetuses in a university hospital in Izmir, Turkey.

      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.
    

Intervention name(s): Prenatal massage therapy
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study type is interventional.As a prospective, randomised, single masking, parallel trial design has been carried out with primipar pregnant women that came to obstetrics polyclinic of a university hospital to evaluate before 30th week.The participants were randomly allocated to the parallel comparison groups by a central office.The sample selection process in the study has been applied according to CONSORT criteria (Moher et al. 2010), and through the permutation method, blocked randomization (Kanık, Tasdelen, and Erdogan 2011) has been done to the records assigned from the centre that the study was applied. The completion decision of the data gathering process has been determined with power analysis that is carried out by the PASS program.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prenatal massage therapy; Pregnant woman; Fetus; Massage Therapy; Prenatal Distress; Prenatal Attachment; Midwife; Nurse