Clinical trial NCT03334097: Educational Intervention in the Fear-Avoidance Delivery
Official title: Educational Intervention in the Fear-Avoidance Delivery: a Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Pregnancy
fear
Parturition
Prenatal Education
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single groupof pregant women will complete the spanish version of Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A, spanish version) before and after an educational information.
Primary purpose: TREATMENT

Brief summary: The aim of this research is to study the responsiveness of the Spanish Version of Wijma Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A) in pregnant women after an educational intervention.

Detailed description: The Wijma Delivery Expectancy/Experience Questionnaire is a self-report instrument designed to measure the fear of childbirth in terms of the woman's cognitive appraisal of childbirth, which is now the most commonly used measure of fear of childbirth. The version A, measures the fear before a delivery (WDEQ-A). It consists of 33 items on a 6-point Likert scale (0 = do not agree; 5 = totally agree). The total score ranges from 0 to 165; the higher the score, the greater the fear the pregnant women experience. A higher score (over 85) indicates a more intense fear of childbirth, and a score of over 100 is considered as a phobia; thus, the scale can measure individual degrees of fear among women before and after their deliveries In Spain, there is no specific instrument to test the effectiveness of different practices that are commonly used to reduce the fear of childbirth as the maternal education. Hence, after cross-cultural adaptation into Spanish of the questionnaire (WDEQ-A-Sp), the responsiveness after and educational intervention will be analysed.

Descriptive analyses will be applied to calculate means and standard deviations of the demographic variables. Distribution and normality will be determined by the one-sample Kolmogorov-Smirnov tests (significance \>0.05). Responsiveness will calculated following COSMIN requirements.

Eligibility criteria: Inclusion Criteria:

* Spanish women living in Málaga, \> 18 years old, 26-30 weeks pregnant, to fill all the items of the questionnaires, to perform sessions the Maternal Education Protocol in Malaga

Exclusion Criteria:

* No performin inclusion criteria. No voluntary participation.

Primary outcomes:
measure: Responsiveness of WDEQ-A-Sp after an educational intervention
timeFrame: inmediate effect
Secondary outcomes:
measure: Age
timeFrame: baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months
measure: Weight
timeFrame: baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months
measure: Height
timeFrame: baseline
measure: Body Mass Index
timeFrame: aseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months
measure: Educational level
timeFrame: baseline
measure: Weeks of gestation
timeFrame: baseline
measure: civil status
timeFrame: baseline
measure: Obstetric history
timeFrame: baseline
measure: evolution of pregnancy
timeFrame: baseline, inmediate effect and 2,4 and 12 weeks.
measure: Previous experience of pregnancy
timeFrame: baseline, inmediate effect and 2,4 and 12 weeks.
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Antonio Cuesta-Vargas
Study officials:
References:
citation: Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
citation: Korukcu O, Kukulu K, Firat MZ. The reliability and validity of the Turkish version of the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) with pregnant women. J Psychiatr Ment Health Nurs. 2012 Apr;19(3):193-202. doi: 10.1111/j.1365-2850.2011.01694.x. Epub 2012 Jan 20.
citation: Pallant JF, Haines HM, Green P, Toohill J, Gamble J, Creedy DK, Fenwick J. Assessment of the dimensionality of the Wijma delivery expectancy/experience questionnaire using factor analysis and Rasch analysis. BMC Pregnancy Childbirth. 2016 Nov 21;16(1):361. doi: 10.1186/s12884-016-1157-8.
citation: Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol. 2010 Jul;63(7):737-45. doi: 10.1016/j.jclinepi.2010.02.006.