Educational Intervention in the Fear-Avoidance Delivery
FADel_edu
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
1 active site
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
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedSeptember 30, 2019
May 1, 2017
1.6 years
July 12, 2017
September 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Responsiveness of WDEQ-A-Sp after an educational intervention
Responsiveness of Spanish Version of Wijma Delivery Expectancy/Experience Questionnaire, Version A (WDEQ-A-Sp) after an educational intervention in pregnant women
inmediate effect
Secondary Outcomes (10)
Age
baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months
Weight
baseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months
Height
baseline
Body Mass Index
aseline, inmediate effect and 2,4 and 12 weeks. Long time effect 6 months
Educational level
baseline
- +5 more secondary outcomes
Study Arms (1)
Experimental arm
EXPERIMENTALThere will only one experimental arm in order to study test-retest validity after having validate the questionnaire. The beginning of the maternal education takes place between 26 and 30 weeks of gestation and ends between 32 and 36 weeks of gestation. Hence, to study responsiveness, questionnaires will be filed at the beginning of the maternal education and after the two educational sessions related to childbirth.
Interventions
Education intervention will consist of a total of six sessions one week apart, with two hours of duration each one. The sessions that are exclusively oriented towards preparation for childbirth are session 1 and session 2. The content of each session is: 1. St. Birth: Start of childbirth, Symptoms and Signs, Delivery schedules, Phases of childbirth, Normal childbirth, Other circumstances (Obstetrical pathology / previous pathology, Induction of labor, Instrumental birth, Caesarean section). 2. nd:methods for relieving birth pain: Alternative Methods of Pain Relief, Pharmacological analgesia, Regional analgesia. Local and regional anesthesia, General anesthesia, breathing training and accompaniment during childbirth- 3. rd: Puerperium. 4. rd :Breastfeeding 5. rd : Newborn care 6. rd :Positive parenting.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antonio Cuesta-Vargas
Málaga, 29010, Spain
Related Publications (4)
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.
PMID: 9638601BACKGROUNDKorukcu 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.
PMID: 22260727BACKGROUNDPallant 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.
PMID: 27871320BACKGROUNDMokkink 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.
PMID: 20494804BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- There will be no masking as the purpose of the study is to analyse responsiveness of a questionnaire after educational intervention
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Researcher CTS631
Study Record Dates
First Submitted
July 12, 2017
First Posted
November 7, 2017
Study Start
June 1, 2017
Primary Completion
December 31, 2018
Study Completion
March 1, 2019
Last Updated
September 30, 2019
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share