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

Pregnancy Related Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007210
• Other study ID #: Yeliz Çakir Koçak
• Secondary ID: 16-ASYO-017
• Status: Completed
• Phase: N/A
• Start date: October 24, 2016
• Est. completion date: November 8, 2017

Study information

• Verified date: August 2021
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Massage Therapy
• Pregnancy Related

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Yeliz Çakir Koçak	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

Alp Dal, N., & Ertem, G. (2016). Fetal Sagligin Degerlendirilmesi ve Tarama Testleri. In Ü. Sevil & G. Ertem (Eds.), Perinatoloji ve Bakim (Birinci ba, pp. 373-408). Ankara Nobel Tip 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. — View Citation

Dereli Yilmaz, S., & Kizilkaya Beji, N. (2013). Prenatal Baglanma Envanterinin Türkçe'ye Uyarlanmasi: Güvenilirlik ve Geçerlilik Çalismasi. Anadolu Hemsirelik ve Saglik Bilimleri Dergisi, 16(2), 103-109.

Eti Aslan, F. (2004). Ameliyat Sonrasi Agri Degerlendirmesinde Görsel Kiyaslama Ölçegiyle Basit Tanimlayici Ölçegin Duyarlik ve Seçiciligi. Yogun Bakim Hemsireligi 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. Review. — View Citation

Kanik, 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

Kilinçer, C., & Zileli, M. (2006). Görsel Analog Hasta Tatmini Skalasi. 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. — View Citation

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche 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. — View Citation

Muller ME. Development of the Prenatal Attachment Inventory. West J Nurs Res. 1993 Apr;15(2):199-211; discussion 211-5. — View Citation

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

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/

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. — View Citation

Yüksel, F., Akin, S., & Durna, Z. (2011). "Prenatal Distres Ölçegi"nin Türkçe'ye Uyarlanmasi ve Faktör Analizi. Hemsirelikte Egitim ve Arastirma Dergisi, 8(3), 43-51.

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prenatal Attachment Inventory (PAI):	The scale was developed by Muller (1993) and its Turkish validity-reliability study was carried out by Dereli Yilmaz and Kizilkaya 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 Kizilkaya 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
Primary	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, Akin, 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	Maternal hearth rate (MHR):	It was carried out for all pregnant women (control and prenatal massage therapy groups) per visiting the hospital for the study by the same midwife. The assessment were made before and after the prenatal massage therapy sessions on the first and last days of the 5-week study (two times for the control group and 10 times for the prenatal massage therapy group between the 30th and 34th gestational weeks).	from 30 weeks up to 34 weeks
Secondary	Fetal hearth rate (FHR):	It was carried out for all pregnant women (control and prenatal massage therapy groups) per visiting the hospital for the study by the same midwife. The assessment were made before and after the prenatal massage therapy sessions on the first and last days of the 5-week study (two times for the control group and 10 times for the prenatal massage therapy group between the 30th and 34th gestational weeks).	from 30 weeks up to 34 weeks
Secondary	Biophysical Profile (BPP):	BPP is a prenatal test used to measure the health of fetus. It has a procedure in which some variables in the USG (fetal breathing movement, fetal body movement, fetal muscle tone, amniotic fluid volume, fetal heart rate reaction) is assessed. The highest score that can be obtained from the BFP assessment is 10 (=4: abnormal, 6: doubtful, 8-10: normal) (Alp Dal and Ertem 2016). It was carried out for all pregnant women (control and prenatal massage therapy groups) per visiting the hospital for the study by the same obstetrician. The assessment were made before and after the prenatal massage therapy sessions on the first and last days of the 5-week study (two times for the control group and 10 times for the prenatal massage therapy group between the 30th and 34th gestational weeks).	from 30 weeks up to 34 weeks
Secondary	Visual Analog Scale (VAS):	It is developed and high reliability have been found by Hayes and Patterson. Its advantages are quickly filled out, simple, interesting, easily scored, the rater is freed from quantitative terms, it requires no master scale (Hayes and Patterson 1921). It is used to make some values that do not measure numerically. The scale is used in many different areas of health. Its main advantage is that it does not have a language and is easy to apply and consisting of a single 100 mm line (Clarke 1964). Cline et al. (1992) found that the vertical use of it is better understood (Cline et al. 1992). The mean value obtained for individuals in the general assessment is taken. Turkish validity and reliability study conducted by Eti Aslan and it is quite reliable in literate group (Eti Aslan 2004). Evaluation was performed over vertical 100 mm measurement in the study.	from 30 weeks up to 34 weeks
Secondary	Visual Analog Patient Satisfaction Scale-VAPSS:	Kilinçer ve Zileli (2006) combined two scales features (Visual Analog Pain Scale and Wong-Baker Scale) and arranged VAPSS. It is a measurement tool that can be applied for individuals and all ages also all culture levels. They reported that the scale can use in pregnant women (Kilinçer and Zileli 2006). Evaluation was performed over vertical 100 mm measurement in the study.	from 30 weeks up to 34 weeks