Delivery;Breech;StillbirthSupportNCT06024811

Investigation of the Effect of Supporting Nursing Care Provided in Line With During Intrapartum Period

An observational study of Delivery;Breech;Stillbirth, run by Balikesir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Delivery;Breech;Stillbirth
What is being tested?: supporting nursing care
Type of treatment: Lifestyle or therapy programme
How many people: 1 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 3 Sep 2020to 15 Feb 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Balıkesir University
Balıkesir, Altıeylül, 10100

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of Supporting Nursing Care Provided in Line With Evidence-Based Practices During Intrapartum Period

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.

Read the 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

Conditions: Delivery;Breech;Stillbirth
Being tested: supporting nursing care
Keywords: supportive nursing care, state anxiety.
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

supporting nursing careBehavioural
Also called Supportive nursing care practices in the latent phase Types of supportive care Physical Emotional Informational Advocacy Partner
Supportive nursing care was applied during the intrapartum period. Latent Active Transition phase,birt, postpartum period

Study groups in NCT06024811
Study group	Role	What they receive
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 . Receives: 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2020-2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 202015 Feb 2021

First posted6 Sep 2023
Study start3 Sep 2020
Primary completion15 Dec 2020
Study completion15 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Delivery;Breech;StillbirthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06024811
Sponsor's protocol ID: Balikesir
Acronym: Support
Status last verified: Aug 2023
First submitted: 25 Jul 2023
Last updated: 6 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21197128
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.
PubMed 28681500
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.
PubMed 29122264
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.
PubMed 35615384
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.
PubMed 30676462
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.
PubMed 23663796
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.
PubMed 17636733
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.
PubMed 23076901
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.
PubMed 28426160
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.
PubMed 26275315
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.
PubMed 22271239
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.
PubMed 29589380
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.
PubMed 27543442
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.
PubMed 36674304
Dai XW. [Scanning electron microscopy of gallstone matrix]. Zhonghua Wai Ke Za Zhi. 1983 Jun;21(6):326-7. No abstract available. Chinese.
PubMed 6641424

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effect of Supporting Nursing Care Provided in Line With Evidence-Based Practices During Intrapartum Period
ClinicalTrials.gov ID: NCT06024811
Acronym / sponsor ID: Support / Balikesir
Conditions: Delivery;Breech;Stillbirth
Keywords: supportive nursing care, state anxiety.
Study type: Observational
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: Balikesir UniversityUniversity, hospital or other
Study start: 3 Sep 2020 (actual)
Primary completion: 15 Dec 2020 (actual)
Study completion: 15 Feb 2021 (actual)
First posted: 6 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
intervention	–	Behavioral: supporting nursing carePregnant 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 .
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).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (6 listed)

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,

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
supporting nursing careAlso: Supportive nursing care practices in the latent phase Types of supportive care Physical Emotional Informational Advocacy PartnerSupportive nursing care was applied during the intrapartum period. Latent Active Transition phase,birt, postpartum period	Behavioural	intervention

Primary outcome

positive birth
Time frame: 2020-2021
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
Background: PubMed 21197128Barrett SJ, Stark MA. Factors associated with labor support behaviors of nurses. J Perinat Educ. 2010 Winter;19(1):12-8. doi: 10.1624/105812410X481528.
Background: PubMed 28681500Bohren 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.
Background: PubMed 29122264Cicek 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.
Background: PubMed 35615384Debeb 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.
Background: PubMed 30676462Gams 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.
Background: PubMed 23663796Silva 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.
Background: PubMed 17636733Hodnett 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.
Background: PubMed 23076901Hodnett 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.
Background: PubMed 28426160Kobayashi 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.
Background: PubMed 26275315Nikula 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.
Background: PubMed 22271239Mortazavi 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.
Background: PubMed 29589380Smith 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

ESRA ÇEVİK principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Delivery;Breech;Stillbirth, run by Balikesir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

positive birth (time frame: 2020-2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06024811, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.