Clinical trial NCT06024811: Investigation of the Effect of Supporting Nursing Care Provided in Line With During Intrapartum Period
Official title: Investigation of the Effect of Supporting Nursing Care Provided in Line With Evidence-Based Practices During Intrapartum Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delivery;Breech;Stillbirth
Keywords: supportive nursing care
state anxiety.
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The universe of the research consisted of pregnant women who applied to the delivery unit of a hospital to give birth in Balıkesir, Turkiye. A total of 4634 deliveries took place in this hospital in 2019, of which 2315 were normal deliveries. (https://balikesirism.saglik.gov.tr/ accessed on 2021 Aug 18). The sample size in the study was calculated with the G\*power 3.1.9.2 program. Since the scores will be compared in the two dependent groups before and after the intervention, the minimum sample size was calculated as 54, 27 people in each group, based on the two-way hypothesis, 5% type I error, 0.50 Cohen's effect size, and 95% power

Brief summary: Aim: The aim of the research was to examine the effect of supportive nursing care provided in line with evidence-based practices during the intrapartum period.

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

Eligibility criteria: 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)

Primary outcomes:
measure: positive birth
timeFrame: 2020-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Balıkesir University
state: Altıeylül
Study officials:
affiliation: https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
name: ESRA ÇEVİK
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Dai XW. [Scanning electron microscopy of gallstone matrix]. Zhonghua Wai Ke Za Zhi. 1983 Jun;21(6):326-7. No abstract available. Chinese.