The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction

NCT ID: NCT05720962

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants who comes into childbirth needs the support of people around her in order to cope with the stress, anxiety and labor pain she experiences. This support is the continuous birth support given from the time the participants comes to the hospital until the birth of the baby. Having someone who supports the woman during the birth process will provide a positive birth experience for pregnant women. At the same time, the feeling of pain of the supported woman will be reduced and the delivery time will be shortened.

This randomized controlled study was planned to be performed on primiparous pregnant women between January 2023 and January 2024. The data of the study will be collected with "Personal Information Form", "Visual Analog Scale".

The study was divided into two groups as experimental and control groups. 55 participants in the experiment -55 participants will be randomized to the control group. Participants meeting the inclusion criteria will be asked to rate their pain and satisfaction from 0 to 10 with the VAS 4 cm, 6 cm, 8 cm and fully open. While both groups receive routine midwife support, when the experimental group reaches 4 cm, a person they want will be taken with them and continuous support will be given until there is a dilation of 10 cm.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Continuous Birth Support

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study with two groups as control and experimental group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

The experimental group will be provided with routine midwife support and uninterrupted accompanying support.

Group Type EXPERIMENTAL

uninterrupted accompanying support

Intervention Type PROCEDURE

When the participants in the experimental group are taken to the delivery unit, when the neck dilation is 4 cm, a person they want will be taken with them to support them.

Afterwards, the pain status and satisfaction of the participants will be questioned when it is 4 cm, 6 cm, 8 cm and 10 cm.

control group

Only routine midwife support will be provided to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

uninterrupted accompanying support

When the participants in the experimental group are taken to the delivery unit, when the neck dilation is 4 cm, a person they want will be taken with them to support them.

Afterwards, the pain status and satisfaction of the participants will be questioned when it is 4 cm, 6 cm, 8 cm and 10 cm.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-35 years old
* Being literate
* Fluent and speaking Turkish
* Primiparous
* Spontaneous vaginal delivery planned
* At the beginning of the active phase (dilatation 4 cm)
* Pregnant women who agreed to participate in the research

Exclusion Criteria

* Presence of a health problem in the mother during pregnancy
* At risk of fetal anomaly
* Having multiple pregnancy
* Administering analgesic medication during labor
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

dilan cömert

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dilan Cömert

Role: PRINCIPAL_INVESTIGATOR

Msc Midwife

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Universty Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022/401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Showering During Labor
NCT05529823 COMPLETED NA