Trials / Unknown
UnknownNCT04423081
Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) (EXIT)
Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) Self-questionnaire Assessing Women's Feelings About the Onset of Childbirth
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 130 (estimated)
- Sponsor
- University Hospital, Clermont-Ferrand · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to cross-culturally adapt and validate the French version of the EXIT scale: an assessment tool on induction of labor.
Detailed description
Favourable agreement was obtained from the authors to adapt the Australian moose tool in a cross-cultural manner. None of the co-authors expressed a desire to collaborate on our project. The EXIT questionnaire is free of rights. The translation of the EXIT questionnaire into French will be carried out according to the recommended steps of the cross-cultural adaptation process (21, 22, 25): translation of the source version into French by three native French translators, adaptation of the different translations by a group of experts, back translation by two native English speakers, testing with a panel of women who have been triggered for childbirth, in order to arrive at the final version which will be evaluated in a sample of the target population. Information about the study will be given to women between Day 2 and Day 4 postpartum. Patients' non-opposition to participate in this study will be collected in the patient's medical record. Recruitment of subjects: the study will be proposed to all eligible women who have been induced for their delivery and with an unfavourable cervix in the obstetrics department of the CHU Estaing, Clermont-Ferrand. Completion of the questionnaire: women will complete the EXIT self-questionnaire between D2 and D4 post-delivery. The data collection will include additional socio-demographic and clinical information for each woman participating in the study from their medical records. The test-retest involves filling in the EXIT questionnaire twice at one to two week intervals. The women will be contacted by phone one week after the first EXIT test, to inform them that a link will be sent by e-mail to complete the EXIT questionnaire online (on Redcap) a second time. They will be called back a second time a week later if the questionnaire is not completed online.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | EXIT scale | completion of EXIT scale translated in french |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2020-11-01
- Completion
- 2021-01-01
- First posted
- 2020-06-09
- Last updated
- 2020-06-09
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04423081. Inclusion in this directory is not an endorsement.