Labour Pain is a Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on Indirect Factors

NCT05226208 | Completed DMC

• 1 other identifier: 0002-9033-149X
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

Pain During Childbirth is a Complex and Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on the Intensity of Labour Pain and Many Indirect Factors. Complex Interrelated Effects on Labour Pain Are Limited by the Little Number of Studies Available. That is Why it is Necessary to Determine the Probable Factors That May Affect the Intensity of Pain.

Conditions

Pain, Labor

Keywords

labor pain; antenatal education; support by doula

Outcome Measures

Primary Outcomes (1)

• Prenatal anxiety level

  Generalized Anxiety Disorder-2 scale is a tool, which confirms the diagnosis of generalized anxiety disorder. A positive Generalized Anxiety Disorder-2 scale result is a score of at least 3 points. It is considered to be negative outcome.

  6 months

Study Arms (2)

Women with not severe labour pain

Group 1 included 282 patients (pain level ≥7 mm according to the VAS).

Diagnostic Test: Visual analogue scale (VAS); Diagnostic Test: General anxiety scale (GAD-2) and survey

Women with severe labour pain

Group 2 included 84 patients (pain level ≤ 6 mm using the VAS).

Diagnostic Test: Visual analogue scale (VAS); Diagnostic Test: General anxiety scale (GAD-2) and survey

Interventions

Visual analogue scale (VAS) DIAGNOSTIC_TEST

In the postpartum period all patients filled VAS and underwent interviews from the 1st to the 3rd day after delivery.

Women with not severe labour pain; Women with severe labour pain

General anxiety scale (GAD-2) and survey DIAGNOSTIC_TEST

In the postpartum period all patients filled survey with GAD-2 and underwent interviews from the 1st to the 3rd day after delivery.

Women with not severe labour pain; Women with severe labour pain

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: mothers over 18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus

You may qualify if:

• mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus.

You may not qualify if:

• mothers over 45 years of age, inability to obtain the informed consent of the patient or his legal representative.

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Bogomolets National Medical University

Kiev, Ukraine

Location

Related Links

• World Health Organization (WHO). Intrapartum care for a positive childbirth experience: a practical guide. Accessed 7 February 2018.

MeSH Terms

Conditions

Labor Pain

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Iurii Kuchyn, PhD

  Bogomolets National Medical University

  STUDY DIRECTOR

• Dmytro Govsieiev, PhD

  Bogomolets National Medical University

  STUDY DIRECTOR

• Kateryna Bielka, PhD

  Bogomolets National Medical University

  STUDY CHAIR

• Anastasiia Romanenko, MD

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: February 7, 2022
• Study Start: December 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 28, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

UA (1)