- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06024811
Investigation of the Effect of Supporting Nursing Care Provided in Line With During Intrapartum Period (Support)
Investigation of the Effect of Supporting Nursing Care Provided in Line With Evidence-Based Practices During Intrapartum Period
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods Design and Settings This study with intervention-control group, randomized and intervention type was carried out in a hospital in Balikesir, located in the west of Turkiye.
Hypotheses Hypothesis 1: Supportive nursing care provided in line with evidence-based practices during the intrapartum period has an effect on the state anxiety level of women.
Hypothesis 2: Supportive nursing care provided in line with evidence-based practices during the intrapartum period has an effect on perceived labor pain.
Hypothesis 3: Supportive nursing care provided in the intrapartum period in line with evidence-based practices has an effect on the duration on birth.
Hypothesis 4: Supportive nursing care provided in line with evidence-based practices in the intrapartum period has an effect on maternal satisfaction.
Universe and sample of the research
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Altıeylül
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Balıkesir, Altıeylül, Turkey, 10100
- Balıkesir University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women over 18 years of age,
- with cervical dilatation 3 cm or more,
- Planned for spontaneous vaginal delivery,
- Term and singleton pregnancy,
- Who speak Turkish, who did not have language communication problems,
- Who voluntarily agreed to participate in the study were included
Exclusion Criteria:
- Pregnant women with head-pelvis incompatibility
- Those who gave birth by cesarean section before
- Pregnant women planned for cesarean delivery
- Pregnant women with any systemic disease (Diabetes mellitus, hypertension, etc.)
- Pregnant women who develop fetal distress or hypoxia during labor)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
intervention
Pregnant women over 18 years of age, with cervical dilatation 3 cm or more, planned for spontaneous vaginal delivery, term and singleton pregnancy, who speak Turkish, who did not have language communication problems, and who voluntarily agreed to participate in the study were included. Pregnant women in the intervention and control groups were randomized using the "www.random.org website" on the computer (intervention=56 control= 56).Intervention and control groups were randomized according to some basic variables (age group, education level, body mass index, number of births and pregnancies, participation in prenatal preparation classes) considering the literature . |
Supportive nursing care was applied during the intrapartum period.
Latent Active Transition phase,birt, postpartum period
Other Names:
|
|
control
Pregnant women over 18 years of age, with cervical dilatation 3 cm or more, planned for spontaneous vaginal delivery, term and singleton pregnancy, who speak Turkish, who did not have language communication problems, and who voluntarily agreed to participate in the study were included. During the data collection period of the study, 313 women were evaluated according to the inclusion and exclusion criteria. Women who did not meet the inclusion criteria (n=198) and refused to participate in the study (n=3) were not included in the study sample. Pregnant women in the intervention and control groups were randomized using the "www.random.org website" on the computer (intervention=56 control= 56).Intervention and control groups were randomized according to some basic variables (age group, education level, body mass index, number of births and pregnancies, participation in prenatal preparation classes) considering the literature (Taghenijad et al. 2010; Erdogan et al. 2017). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
positive birth
Time Frame: 2020-2021
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The positive birth highlights the importance of woman-centred care to optimize the experience of labour and childbirth for women and their babies through a holistic, human rights-based approach.
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2020-2021
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ESRA ÇEVİK, https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
Publications and helpful links
General Publications
- Smith CA, Levett KM, Collins CT, Dahlen HG, Ee CC, Suganuma M. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009290. doi: 10.1002/14651858.CD009290.pub3.
- Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.
- Barrett SJ, Stark MA. Factors associated with labor support behaviors of nurses. J Perinat Educ. 2010 Winter;19(1):12-8. doi: 10.1624/105812410X481528.
- Cicek S, Basar F. The effects of breathing techniques training on the duration of labor and anxiety levels of pregnant women. Complement Ther Clin Pract. 2017 Nov;29:213-219. doi: 10.1016/j.ctcp.2017.10.006. Epub 2017 Oct 18.
- Debeb Sendekie A, Belay MA, Ayalew Yimer S, Degu Ayele A. Evidence-Based Intrapartum Practice and Associated Factors Among Obstetric Care Providers Working in Public Hospitals of South Wollo Zone North-Central Ethiopia: An Institutional-Based Cross-Sectional Study. Int J Womens Health. 2022 May 19;14:719-730. doi: 10.2147/IJWH.S351795. eCollection 2022.
- Gams B, Neerland C, Kennedy S. Reducing Primary Cesareans: An Innovative Multipronged Approach to Supporting Physiologic Labor and Vaginal Birth. J Perinat Neonatal Nurs. 2019 Jan/Mar;33(1):52-60. doi: 10.1097/JPN.0000000000000378.
- Silva Gallo RB, Santana LS, Jorge Ferreira CH, Marcolin AC, Polineto OB, Duarte G, Quintana SM. Massage reduced severity of pain during labour: a randomised trial. J Physiother. 2013 Jun;59(2):109-16. doi: 10.1016/S1836-9553(13)70163-2.
- Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003766. doi: 10.1002/14651858.CD003766.pub2.
- Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003766. doi: 10.1002/14651858.CD003766.pub4.
- Kobayashi S, Hanada N, Matsuzaki M, Takehara K, Ota E, Sasaki H, Nagata C, Mori R. Assessment and support during early labour for improving birth outcomes. Cochrane Database Syst Rev. 2017 Apr 20;4(4):CD011516. doi: 10.1002/14651858.CD011516.pub2.
- Nikula P, Laukkala H, Polkki T. Mothers' Perceptions of Labor Support. MCN Am J Matern Child Nurs. 2015 Nov-Dec;40(6):373-80. doi: 10.1097/NMC.0000000000000190.
- Mortazavi SH, Khaki S, Moradi R, Heidari K, Vasegh Rahimparvar SF. Effects of massage therapy and presence of attendant on pain, anxiety and satisfaction during labor. Arch Gynecol Obstet. 2012 Jul;286(1):19-23. doi: 10.1007/s00404-012-2227-4. Epub 2012 Jan 21.
- Weeks F, Pantoja L, Ortiz J, Foster J, Cavada G, Binfa L. Labor and Birth Care Satisfaction Associated With Medical Interventions and Accompaniment During Labor Among Chilean Women. J Midwifery Womens Health. 2017 Mar;62(2):196-203. doi: 10.1111/jmwh.12499. Epub 2016 Aug 20.
- Wanyenze EW, Nalwadda GK, Byamugisha JK, Muwanguzi PA, Tumwesigye NM. Effect of Midwife-Provided Orientation of Birth Companions on Maternal Anxiety and Coping during Labor: A Stepped Wedge Cluster Randomized Control Trial in Eastern Uganda. Int J Environ Res Public Health. 2023 Jan 14;20(2):1549. doi: 10.3390/ijerph20021549.
- Dai XW. [Scanning electron microscopy of gallstone matrix]. Zhonghua Wai Ke Za Zhi. 1983 Jun;21(6):326-7. No abstract available. Chinese.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Balikesir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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