NCT06024811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 25, 2023

Last Update Submit

August 29, 2023

Conditions

Keywords

supportive nursing carestate anxiety.

Outcome Measures

Primary Outcomes (1)

  • positive birth

    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.

    2020-2021

Study Arms (2)

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 .

Behavioral: supporting nursing care

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).

Interventions

Supportive nursing care was applied during the intrapartum period. Latent Active Transition phase,birt, postpartum period

Also known as: Supportive nursing care practices in the latent phase Types of supportive care Physical Emotional Informational Advocacy Partner
intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women over 18 years of age.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balıkesir University

Balıkesir, Altıeylül, 10100, Turkey (Türkiye)

Location

Related Publications (15)

  • 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.

    PMID: 21197128BACKGROUND
  • 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.

    PMID: 28681500BACKGROUND
  • 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.

    PMID: 29122264BACKGROUND
  • 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.

    PMID: 35615384BACKGROUND
  • 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.

    PMID: 30676462BACKGROUND
  • 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.

    PMID: 23663796BACKGROUND
  • 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.

    PMID: 17636733BACKGROUND
  • 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.

    PMID: 23076901BACKGROUND
  • 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.

    PMID: 28426160BACKGROUND
  • 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.

    PMID: 26275315BACKGROUND
  • 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.

    PMID: 22271239BACKGROUND
  • 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.

    PMID: 29589380BACKGROUND
  • 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.

    PMID: 27543442BACKGROUND
  • 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.

    PMID: 36674304BACKGROUND
  • Dai XW. [Scanning electron microscopy of gallstone matrix]. Zhonghua Wai Ke Za Zhi. 1983 Jun;21(6):326-7. No abstract available. Chinese.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • ESRA ÇEVİK

    https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

July 25, 2023

First Posted

September 6, 2023

Study Start

September 3, 2020

Primary Completion

December 15, 2020

Study Completion

February 15, 2021

Last Updated

September 6, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations