The Effects of Whole Body Prenatal Massage Therapy During Pregnancy: A Randomized Controlled Experimental Trial

NCT05007210 | Completed DMC

• 2 other identifiers: Yeliz Çakır Koçak16-ASYO-017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Massage Therapy; Pregnancy Related; Fetus Fetus

Keywords

Prenatal massage therapy; Pregnant woman; Fetus; Massage Therapy; Prenatal Distress; Prenatal Attachment; Midwife; Nurse

Outcome Measures

Primary Outcomes (2)

• Prenatal Attachment Inventory (PAI):

  The scale was developed by Muller (1993) and its Turkish validity-reliability study was carried out by Dereli Yılmaz and Kızılkaya Beji (2013). It is used to explain women's thoughts, feelings and situations during pregnancy and to determine the level of attachment to the baby in the prenatal period. Increased score from the scale shows that the prenatal attachment level increases. Cronbach alpha reliability coefficients ranged from 0.81 (Muller 1993) and 0.84 (Dereli Yilmaz and Kızılkaya Beji 2013). The internal reliability of this instrument was 0.87 for 30th week and 0.90 for 34th week in this sample.

  from 30 weeks up to 34 weeks

• Revised Prenatal Distress Questionnaire (NuPDQ):

  The scale with different versions was developed by Yali and Lobel and the version of 17-item NuPDQ was revised by Lobel et al. (Lobel 2008; Yali and Lobel 1999). Its Turkish validity-reliability study was carried out by Yüksel et all. (Yüksel, Akın, and Durna 2011). It evaluates difficulties in pregnancy which about specific concerns and anxieties specific to the pregnancy period, such as medical problems, physical symptoms, parenting, relationships, bodily changes, birth and baby's health. The reduction of the total score of the scale shows that the prenatal distress level perceived by pregnant women decreases. Cronbach alpha reliability coefficients ranged from 0.79-0.88 (Ibrahim and Lobel 2020) and 0.85 (Yüksel et al. 2011). The internal reliability of this instrument was 0.73 for 30th week and 0.85 for 34th week in this sample.

  from 30 weeks up to 34 weeks

Secondary Outcomes (5)

• Maternal hearth rate (MHR):

  from 30 weeks up to 34 weeks

• Fetal hearth rate (FHR):

  from 30 weeks up to 34 weeks

• Biophysical Profile (BPP):

  from 30 weeks up to 34 weeks

• Visual Analog Scale (VAS):

  from 30 weeks up to 34 weeks

• Visual Analog Patient Satisfaction Scale-VAPSS:

  from 30 weeks up to 34 weeks

Study Arms (2)

Prenatal massage therapy group

EXPERIMENTAL

Prenatal massage therapy for prenatal attachment, physiological and psychological distress, maternal and fetal well-being.

Other: Prenatal massage therapy

Control group

NO INTERVENTION

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.

Interventions

Prenatal massage therapy OTHER

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.

Prenatal massage therapy group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Yeliz Çakır Koçak

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

Related Publications (16)

• 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.

  BACKGROUND

• Clarke, M. (1964). Reliability and sensibility in the self-assessment of well-being. Bul Br Psy Soc, 17(18A).

  BACKGROUND

• 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.

  PMID: 1437591 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Hayes, M. H. S., & Patterson, D. G. (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99.

  BACKGROUND

• 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.

  PMID: 31183596 BACKGROUND

• 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

  BACKGROUND

• Kılınçer, C., & Zileli, M. (2006). Görsel Analog Hasta Tatmini Skalası. Trakya Univ Tip Fak Derg, 23(3), 113-118.

  BACKGROUND

• 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.

  PMID: 18823187 BACKGROUND

• 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.

  PMID: 20332511 BACKGROUND

• 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.

  PMID: 8470375 BACKGROUND

• Osborne, C. (2015). Pre- and Perinatal Massage Therapy Certification Workshop Student Guide (Special Document).

  BACKGROUND

• 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.

  PMID: 10212886 BACKGROUND

• 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.

  BACKGROUND

• 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/

  RESULT

MeSH Terms

Conditions

Fetus-in-Fetu

Condition Hierarchy (Ancestors)

Twins, Conjoined; Abnormalities, Severe Teratoid; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pregnant women in control and prenatal massage therapy groups were appointed to different times to avoid each other. At the beginning of the study, they didn't know in which group they were taken to participate in the study. In the process of gathering data, the single-blind method has been applied, and the double-blind method has only been applied to data analysis (The double-blind method was not used in the data collection process in order to reveal the loss of the study conducted within the scope of the doctoral thesis and the fact that prenatal massage therapy practice is not performed routinely in country conditions). However, single blinding was performed in terms of the outcomes. The data obtained from the research were analyzed by Biostatistics and Medical Information Department at Ege University.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwifery Research Asistant

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: August 16, 2021
• Study Start: October 24, 2016
• Primary Completion: August 8, 2017
• Study Completion: November 8, 2017
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)