Clinical trial NCT05007210: The Effects of Whole Body Prenatal Massage Therapy During Pregnancy: A Randomized Controlled Experimental Trial
Official title: The Effects of the One Hour-Whole Body Prenatal Massage Therapy Session on Prenatal Distress and Prenatal Attachment for Women and Their Fetuses During Late Pregnancy: A Randomized Controlled Experimental Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage Therapy
Pregnancy Related
Fetus Fetus
Keywords: Prenatal massage therapy
Pregnant woman
Fetus
Massage Therapy
Prenatal Distress
Prenatal Attachment
Midwife
Nurse
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 20-35 years-old
* 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:

* Infertility story
* High risk pregnancy
* Live or stillbirth after 20th week of gestation
* Abortion after the first trimester
* History of recurrent pregnancy loss

Primary outcomes:
measure: Prenatal Attachment Inventory (PAI):
timeFrame: from 30 weeks up to 34 weeks
measure: Revised Prenatal Distress Questionnaire (NuPDQ):
timeFrame: from 30 weeks up to 34 weeks
Secondary outcomes:
measure: Maternal hearth rate (MHR):
timeFrame: from 30 weeks up to 34 weeks
measure: Fetal hearth rate (FHR):
timeFrame: from 30 weeks up to 34 weeks
measure: Biophysical Profile (BPP):
timeFrame: from 30 weeks up to 34 weeks
measure: Visual Analog Scale (VAS):
timeFrame: from 30 weeks up to 34 weeks
measure: Visual Analog Patient Satisfaction Scale-VAPSS:
timeFrame: from 30 weeks up to 34 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Yeliz Çakır Koçak
state: Bornova
Study officials:
References:
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