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

NCT05520060 | Completed

• 1 other identifier: 03.06.2022/49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Keywords

Continuous midwifery care; supportive care; Labor pain; Comfort,

Outcome Measures

Primary Outcomes (4)

• Birth Comfort Scale

  Change from birth comfort between passive phase of childbirth and active phase of childbirth.

  pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in comfort level.

• Birth Satisfaction Scale

  Birth satisfaction in the early postpartum period.

  immediately after the intervention/1-4 hours postpartum. An increase in the score is interpreted as an increase in satisfaction level.

• Scale of Pain Expression during Childbirth (ESVADOPA)

  Change from pain expression level between passive phase of childbirth and active phase. of childbirth.

  pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth.An increase in the score is interpreted as an increase in the expression of pain.

• Visual Analog Scale

  Change from pain between passive phase of childbirth and active phase of childbirth.

  pre-intervention/passive phase of childbirth; immediately after the intervention/active phase of childbirth. An increase in the score is interpreted as an increase in pain.

Study Arms (2)

experimental

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.

Other: Physical support; Other: Psychospiritual support; Other: Environmental and sociocultural support; Other: Routine care

Control

PLACEBO COMPARATOR

The experimental group will be placed in routine midwifery care.

Other: Routine care

Interventions

Physical support 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

Also known as: Supportive Care

experimental

Psychospiritual support OTHER

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

Also known as: Supportive Care

experimental

Environmental and sociocultural support 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

Also known as: Supportive Care

experimental

Routine care OTHER

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

Also known as: Health care

Control; experimental

Eligibility Criteria

• Gender Eligibility Details: Participants are women who have given birth.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• high risk pregnancy
• Multiple pregnancy
• Breech presentation
• Induction of labor
• Emergency cesarean section indication

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Palliative Care; Environment; Delivery of Health Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 29, 2022
• Study Start: December 5, 2022
• Primary Completion: January 15, 2024
• Study Completion: May 1, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)