Clinical trial NCT06375746: The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve.
Official title: The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-04-19
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: STAI questionnaire score
timeFrame: 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:
measure: satisfaction questionnaire
timeFrame: After completion of IOL (either immediately after insertion of EAB or first PGE2 tablet).
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Wolfson Medical Center
Study officials:
References:
citation: Goffinet F, Dreyfus M, Carbonne B, Magnin G, Cabrol D. [Survey of the practice of cervical ripening and labor induction in France]. J Gynecol Obstet Biol Reprod (Paris). 2003 Nov;32(7):638-46. French.
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citation: Kleiner I, Mor L, Friedman M, Abeid AA, Shoshan NB, Toledano E, Bar J, Weiner E, Barda G. The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief-a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101222. doi: 10.1016/j.ajogmf.2023.101222. Epub 2023 Nov 10.