Induction of Labor Affected Fetus / Newborn
Conditions
Brief summary
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.
Detailed description
The prevalence of induction of labor (IOL) has increased over the last decade, reaching between 15 to 30% of all deliveries in developed countries. IOL is commonly carried out using an extra-amniotic balloon (mechanical induction) or prostaglandins (pharmacological induction). Medical indications for IOL include maternal and fetal indications, where inducing labor results in improved maternal and neonatal outcomes compared with conservative management. The process of labor induction can be associated with anxiety, especially in women undergoing IOL for the first time. Previous studies have focused on IOL success, examining the vaginal delivery rate or the time to delivery. Only a few studies have addressed the discomfort and anxiety that might accompany the procedures of IOL. A previous study from Australia found that women undergoing IOL wished to be presented with choice options, and receive more information about the process and its possible risks. A Swedish study found that the birth experience of women who underwent labor induction was less positive than that of women who gave birth spontaneously, with the former expressing greater concern for the baby's health. Personalized video technology allows for the creation of a customized instructional videos, that may help reduce anxiety and decrease the element of uncertainty regarding IOL process and the expected fetal health. A possible advantage of this technology is that it may better engage patients and explain the medial intervention in a simple and clear manner. Many studies have examined the effect of presenting video clips, whether standardized or personalized, before medical procedures. These studies have shown significant effectiveness in improving adherence and strengthening the individual's commitment to the procedure, as well as creating a deeper understanding of the future events when using this technology. This technology is a simple method that does not involve pharmacological or invasive medical interventions to alleviate pain and anxiety. The aim of this study is to examine whether using a personalized video reduces patients level of anxiety during induction of labor.
Interventions
OTHERPersonalized video
After 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.
Sponsors
Wolfson Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * No language barrier preventing completion of the questionnaire.
Exclusion criteria
* Sensitivity to PGE2. * Preterm labor. * Premature rupture of membranes. * Stillbirth. * Elective pregnancy termination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| STAI questionnaire score | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| satisfaction questionnaire | After completion of IOL (either immediately after insertion of EAB or first PGE2 tablet). | 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). |
Countries
Israel
Contacts
Primary ContactMatan Friedman, MD
Outcome results
None listed