Consequences of Admission to the Delivery Room in the Early and Late Phases

NCT06344741 | Completed

• 1 other identifier: sdilek6
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G\*Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses.

Conditions

Fear of Childbirth; Neonatal; Pain; Maternal Distress (During Labor); Satisfaction

Keywords

Childbirth; Maternal; Phases

Outcome Measures

Primary Outcomes (2)

• Neonatal pain and stress

  ALPS-Neo: It is a 3-point Likert type scale consisting of 5 items: facial expression of the newborn, breathing pattern, tone of extremities, hand and foot activities and activity level. Measurements are made through observation. As stress and pain increase, the score obtained also increases. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and above 5 points indicate the presence of serious pain and stress.

  15th minute after birth

• Birth satisfaction

  Birth satisfaction will be measured with a 10cm line visual analogue scale. The participant will be asked about her satisfaction with the birth and will be asked to mark his or her satisfaction on a visual analogue scale. The lowest score from the scale is 0, the highest score is 10.

  5th hour postpartum

Secondary Outcomes (2)

• Maternal Anxiety

  During the first 10 minutes of the participant's admission to the delivery room

• Fear of Birth

  During the first 10 minutes of the participant's admission to the delivery room

Study Arms (2)

Latent phase

Participants admitted to the delivery room in the latent phase will be included.

Behavioral: Accepted in latent phase

Active phase

Participants accepted to the delivery room in the active phase will be included.

Behavioral: Accepted in active phase

Interventions

Accepted in latent phase BEHAVIORAL

Participants admitted to the delivery room in the latent phase will be included. Routine procedures will be performed.

Also known as: Latent phase

Latent phase

Accepted in active phase BEHAVIORAL

Participants admitted to the delivery room in the active phase will be included. Routine procedures will be performed.

Also known as: Active phase

Active phase

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who applied to the delivery room during the study period and met the inclusion criteria

You may qualify if:

• Ages 18 and over,
• At term gestational age (37-42 weeks),
• Does not have a risky pregnancy,
• Single pregnancy,
• Head presentation,
• Literate participants will be included

You may not qualify if:

• Those who do not have sufficient mental health to fill out the survey form,
• Visual, hearing, perception impaired
• The newborn is unhealthy or stillborn,
• With membrane rupture
• Having a history of cesarean section
• Those who have contraindications for vaginal birth
• Having complaints of pregnancy-related bleeding,
• Any risk of birth (placental abruption, uterine rupture, etc.)
• Willing to leave at any point during the research

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• Lundqvist P, Kleberg A, Edberg AK, Larsson BA, Hellstrom-Westas L, Norman E. Development and psychometric properties of the Swedish ALPS-Neo pain and stress assessment scale for newborn infants. Acta Paediatr. 2014 Aug;103(8):833-9. doi: 10.1111/apa.12672. Epub 2014 May 26.

  PMID: 24813238 BACKGROUND

MeSH Terms

Conditions

Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Officials

• Sena Dilek Aksoy, Ph.D.

  Kocaeli University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 3, 2024
• Study Start: October 13, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 31, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-06

Locations

TU (1)