The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve.

Wolfson Medical Center (WMC)

Status: Enrolling

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Other: Personalized video

Study type: Interventional

Funder types: Other

Identifiers

NCT06375746

0091-22-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Personalized video group

Experimental group

Description:

In the video group patients will watch a personalized video prior to initiation of IOL in addition to standard counseling.

Treatment:

Other: Personalized video

Control group

No Intervention group

Description:

Patients will receive only standard counselling prior to initiation of IOL.