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NCT Number: NCT06375746

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wolfson Medical Center

Holon, Israel

Location status: Recruiting

Location contact

Matan Friedman

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized video

Other

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.

Other names: Video group

Primary outcomes

  1. STAI questionnaire score

    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).

    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 outcomes

  1. satisfaction questionnaire

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Matan Friedman, MD

CONTACT

[email protected]

+972544210360

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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