The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve.
NCT ID: NCT06375746
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2024-05-01
2024-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Personalized video group
In the video group patients will watch a personalized video prior to initiation of IOL in addition to standard counseling.
Personalized 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.
Control group
Patients will receive only standard counselling prior to initiation of IOL.
No interventions assigned to this group
Interventions
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Personalized 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Preterm labor.
* Premature rupture of membranes.
* Stillbirth.
* Elective pregnancy termination.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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Locations
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Wolfson Medical Center
Holon, , Israel
Countries
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Central Contacts
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Facility Contacts
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Matan Friedman
Role: primary
References
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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.
Mackenzie IZ. Induction of labour at the start of the new millennium. Reproduction. 2006 Jun;131(6):989-98. doi: 10.1530/rep.1.00709.
Declercq ER, Sakala C, Corry MP, Applebaum S. Listening to Mothers II: Report of the Second National U.S. Survey of Women's Childbearing Experiences: Conducted January-February 2006 for Childbirth Connection by Harris Interactive(R) in partnership with Lamaze International. J Perinat Educ. 2007 Fall;16(4):15-7. doi: 10.1624/105812407X244778.
National Collaborating Centre for Women and Children'sHealth. Induction of labour. London: NICE, 2008
Public Health Agency of Canada. Canadian Perinatal Health Report, 2008 edn. Ottawa: Public Health Agency of Canada, 2008
Mozurkewich EL, Chilimigras JL, Berman DR, Perni UC, Romero VC, King VJ, Keeton KL. Methods of induction of labour: a systematic review. BMC Pregnancy Childbirth. 2011 Oct 27;11:84. doi: 10.1186/1471-2393-11-84.
Nuutila M, Halmesmaki E, Hiilesmaa V, Ylikorkala O. Women's anticipations of and experiences with induction of labor. Acta Obstet Gynecol Scand. 1999 Sep;78(8):704-9.
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.
Other Identifiers
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0091-22-WOMC
Identifier Type: -
Identifier Source: org_study_id
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