The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWolfson Medical Center
About this trial
To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women, aged 18-45, undergoing medical IOL at term.
Unfavorable cervix (BISHOP score <6).
Cervical ripening with either prostaglandin E2 (PGE2) tablets or extra-amniotic balloon (EAB).
Provided consent to participate in the study.
Disqualifiers
Sensitivity to PGE2.
Preterm labor.
Premature rupture of membranes.
Stillbirth.
Trial design
Design model
Parallel
Treatments tested in this trial
Personalized video
Other interventionAfter enrollment and assignment to the intervention group, patients will receive a link to a personalized video describing the different induction methods by a text message.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Personalized video groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
STAI questionnaire score
This is a validated questionnaire for the assessment of state anxiety called the State-Trait Anxiety Inventory (STAI). It includes 20 items presenting feelings characteristic of anxiety. Participants will be asked to rate how much each of the described feelings characterizes them at the moment on a scale ranging from 1 (not at all) to 4 (very much so). The final score on each questionnaire is obtained by summing all the ratings, after reversing the scale on the positively worded items. A higher score indicates a higher level of anxiety.
Time frame
Patient in both the study and the control groups will be asked to complete the STAI questionnaire twice as detailed below: • Prior to labor induction • After completion of IOL (either immediately after insertion of EAB or first PGE2 tablet).Secondary outcomes
1
satisfaction questionnaire
Participants in both groups will be asked to complete a satisfaction questionnaire after IOL on a scale of one to five (1 - very low satisfaction, 2 - low satisfaction, 3 - moderate satisfaction, 4 - high satisfaction, 5 - very high satisfaction).
Time frame
After completion of IOL (either immediately after insertion of EAB or first PGE2 tablet).Sponsors and contacts
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Source ClinicalTrials.gov