NCT04883047

Brief Summary

Although labor pain is a physiological and natural process, when the woman cannot cope with labor pain, the health of the mother and fetus is negatively affected. These negative effects mostly focus on the respiratory system, cardiovascular system, neuroendocrine and limbic system. During birth, the mother becomes exhausted due to pain and has to use all her energy to cope with the pain.When the mother can effectively cope with the pain of labor, she starts motherhood with a positive experience, experiences the happiness of actively participating in the birth of the baby, can participate in practices with health professionals, and the problems that can be seen in the newborn are reduced because there is no need for medication. In this respect, it is extremely important for the mother, baby and family to end the birth process in the best possible way. For this reason, nursing care includes emotional, physical, spiritual and psychosocial continuous birth support and coping with the pain of labor. In this direction, the "algorithm for coping with labor pain" developed includes the interventions that should be done to cope with the pain in labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

April 26, 2021

Last Update Submit

July 7, 2021

Conditions

Keywords

coping with labor painbirth satisfactionfear of birth

Outcome Measures

Primary Outcomes (2)

  • Birth satisfaction as assessed by the Birth Satisfaction Scale

    Measurements will be made using the Birth Satisfaction Scale.The total number of points to be obtained from the scale varies between 30 and 150 points, but the scale does not have a cut-off point. As the scores obtained from the scale increase, the level of birth satisfaction increases.

    will be measured in the first 6 hours postpartum

  • Fear of childbirth as assessed by the Wijma Birth Expectation/Experience Scale-Version B

    Measurements will be made using the Wijma Birth Expectancy / Experience Scale Version B. While the minimum score on the scale is 33, the maximum score is 198. The high scores indicate that the fear of childbirth experienced by women is high.

    will be measured in the first 6 hours postpartum

Study Arms (2)

experiment

EXPERIMENTAL

Women in the experimental group will be given care at the first stage of labor (will start in the latent phase) using Integrated Birth Support Strategies created in line with the Algorithm for Coping with Birth Pain. Among the interventions made into a checklist, the interventions applied to the woman will be marked by the midwives and nurses working in the delivery room. The Scale for Coping with Birth Pain (DABS), which will be applied once in each phase (latent phase, active phase and transition phase), will guide the delivery of care; Care practices will differ depending on the woman's ability to cope with labor pain.At least 3 of each sub-heading of the physical comfort parameter, at least 1 of each sub-heading of the parameter of providing emotional comfort, at least 2 of each sub-heading of informative support and advocacy sub-parameters will be applied to pregnant women by midwives / nurses working in the delivery room.

Other: holistic birth support strategies

control

NO INTERVENTION

Pregnant women assigned to the control group will be followed up with the routine care applied in the delivery room.

Interventions

Holistic Birth Support Strategies are composed of birth-supporting practices that were created by Horn and D'Angelo (2017) within the scope of the "Algorithm for Coping with Birth Pain" and recommended for coping with labor pain. Holistic Birth Support Strategies; It includes four parameters: physical comfort, emotional comfort, informative support and advocacy.

experiment

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being in the latent phase of labor
  • Not being a risky pregnant (gestational diabetes, hypertension, preeclampsia etc.)
  • Not having any communication problems (mental, auditory, visual, etc.)

You may not qualify if:

  • Pregnancy does not do the post-test applications
  • Not wanting to participate in interventions applied in line with the algorithm for coping with labor pain
  • Willing to leave the research
  • Delivery by cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük Training and Research Hospital

Karabük, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Şengül YAMAN SÖZBİR, PhD

    Gazi Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was planned as a single center stratified block parallel group randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Expert Nurse, Doctoral student

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 12, 2021

Study Start

May 25, 2021

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations