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

Sponsor

Bogomolets National Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05226208

Collaborator

(none)

366

Enrollment

Location

5.8

Actual Duration (Months)

62.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Labor	Diagnostic Test: Visual analogue scale (VAS) Diagnostic Test: General anxiety scale (GAD-2) and survey

Detailed Description

A prospective observational study was conducted in the period from December 2020 to May 2021 at the Kyiv City Maternity Hospital №5 (Kyiv, Ukraine). The study protocol was approved by the Bogomolets National Medical University Ethics Committee. The examined predictors were derived from mothers' self-report of overall childbirth. 366 women took part in research, 282 of participants rated their pain by ≤ 60 mm visual analog scale (VAS), while 84 patients reported their pain by ≥70 mm VAS. The aim of study was to investigate predictors of severe labour pain. In the postpartum period all patients filled questionnaires and underwent interviews from the 1st to the 3rd day after delivery. The following groups of risk factors were studied:

Demographic indicators (age, level of working capacity 2 months before childbirth, attendance of maternity school).
General level of health (woman's level of health before childbirth, daily physical activity before childbirth, bad habits - smoking during pregnancy).
Presence of mental disorders before childbirth (level of anxiety 2 weeks before childbirth, widespread muscle pain with fatigue or problems with memory, sleep, and mood).
The presence of chronic pain, chronic headache or chronic back pain, the presence of rheumatoid arthritis during pregnancy, the presence of increased intracranial pressure during pregnancy.
Presence of chronic intestinal diseases (irritable bowel syndrome).
The level of assistance during childbirth (constant support of the doula during childbirth, the woman's ability to control pain in childbirth).

Study Design

Study Type:

Observational

Actual Enrollment :

366 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Predictors of Severe Labor Pain: Prospective Observational Study

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

May 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
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) In the postpartum period all patients filled VAS and underwent interviews from the 1st to the 3rd day after delivery. Diagnostic Test: General anxiety scale (GAD-2) and survey 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 severe labour pain Group 2 included 84 patients (pain level ≤ 6 mm using the VAS).	Diagnostic Test: Visual analogue scale (VAS) In the postpartum period all patients filled VAS and underwent interviews from the 1st to the 3rd day after delivery. Diagnostic Test: General anxiety scale (GAD-2) and survey In the postpartum period all patients filled survey with GAD-2 and underwent interviews from the 1st to the 3rd day after delivery.

Arm

Intervention/Treatment

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)

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

Diagnostic Test: General anxiety scale (GAD-2) and survey

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 severe labour pain

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

Diagnostic Test: Visual analogue scale (VAS)

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

Diagnostic Test: General anxiety scale (GAD-2) and survey

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

Outcome Measures

Primary Outcome Measures

Prenatal anxiety level [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bogomolets National Medical University	Kiev		Ukraine

Sponsors and Collaborators

Bogomolets National Medical University

Investigators

Study Director: Iurii Kuchyn, PhD, Bogomolets National Medical University
Study Director: Dmytro Govsieiev, PhD, Bogomolets National Medical University
Study Chair: Kateryna Bielka, PhD, Bogomolets National Medical University
Principal Investigator: Anastasiia Romanenko, MD, Bogomolets National Medical University