The Effect of Continuous Midwifery Care at Birth on Labor Pain, Comfort and Satisfaction

NCT ID: NCT05520060

Last Updated: 2025-01-28

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2024-05-01

Brief Summary

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

Introduction: Birth is a period in which biological, physical, emotional and social changes are experienced. Supportive care provided by the midwife ensures the adaptation of the woman to labor and improves her ability to cope with labor. Supportive care has positive effects on labor and maternal and infant health.

Purpose: This project aimed to determine the birth pain, comfort and satisfaction levels by considering the continuous midwifery care at birth with a holistic approach.

Method: The universe of this study, which will be conducted in randomized controlled experimental type, will consist of pregnant women who applied to Adana City Training and Research Hospital, Gynecology and Obstetrics Clinic, Delivery Room. The number of samples was calculated by G\*power analysis, and it was aimed to carry out the research with 30 participants in the intervention group and 30 participants in the control group. Single-blind randomized assignment and block randomization will be performed to avoid selection bias. Data will be collected using face-to-face interview technique. The pre-test will be applied to pregnant women who apply to the delivery room in the latent phase. While the continuous midwifery care model will be applied to the intervention group, standard midwifery care will be applied to the control group. The final test will be done between 1-4 hours postpartum. The independent variable of the study is continuous midwifery care. The dependent variable is the introductory characteristics of women, labor pain, comfort and satisfaction levels. The data will be analyzed with appropriate analysis methods after performing normality tests.

Detailed Description

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

During childbirth, women need someone's support. Providing continuous care to women with a supportive and holistic approach by midwives who care for women is seen as a potential that can improve labor pain management, birth comfort and satisfaction. The aim of this research is to determine the effect of continuous midwifery care at birth on labor pain, comfort and satisfaction levels.

For this purpose, the objectives are:

* To apply the continuous midwifery care model,
* To increase women's normal birth comfort and satisfaction,
* To create social awareness that midwives play a key role in normal birth,
* Reducing preventable maternal and infant and infant deaths due to care deficiencies,
* To reduce cesarean rates.

Conditions

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

Labor Pain

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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

experimental

The experimental group will be placed in continuous midwifery care. The continuous and supportive care stages to be presented at birth are planned within the framework of Kolcaba's comfort theory. According to this theory, interventions will be applied according to the physical, psychospiritual, environmental and sociocultural comfort needs of women.

Group Type EXPERIMENTAL

Physical support

Intervention Type OTHER

Pharmacological and non-pharmacological methods in pain management, Mobilization, Position preferred by the woman, Fluid and nutritional support, Massage applications, Sacral pressure, Listening to music, Breathing and relaxation exercises

Psychospiritual support

Intervention Type OTHER

Effective communication, Encouragement to speak up and express fears, Support for faith-oriented practices

Environmental and sociocultural support

Intervention Type OTHER

egulating the temperature, light and sound of the room, Environment that promotes respect for privacy, Reducing environmental noise, Information, Social support, Talking about cultural practices, Social support

Routine care

Intervention Type OTHER

Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.

Control

The experimental group will be placed in routine midwifery care.

Group Type PLACEBO_COMPARATOR

Routine care

Intervention Type OTHER

Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.

Interventions

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

Physical support

Pharmacological and non-pharmacological methods in pain management, Mobilization, Position preferred by the woman, Fluid and nutritional support, Massage applications, Sacral pressure, Listening to music, Breathing and relaxation exercises

Intervention Type OTHER

Psychospiritual support

Effective communication, Encouragement to speak up and express fears, Support for faith-oriented practices

Intervention Type OTHER

Environmental and sociocultural support

egulating the temperature, light and sound of the room, Environment that promotes respect for privacy, Reducing environmental noise, Information, Social support, Talking about cultural practices, Social support

Intervention Type OTHER

Routine care

Admission to the delivery room, preparation for birth, delivery, postpartum care, etc.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Supportive Care Supportive Care Supportive Care Health care

Eligibility Criteria

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

Inclusion Criteria

* Volunteering to participate
* Knowing Turkish and being literate,
* Don't be in the latent phase.

Exclusion Criteria

* high risk pregnancy
* Multiple pregnancy
* Breech presentation
* Induction of labor
* Emergency cesarean section indication
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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

Ayseren Cevik

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cukurova University

Adana, , 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.

03.06.2022/49

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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