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

NCT06375746 | Recruiting

• 1 other identifier: 0091-22-WOMC
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• STAI questionnaire score

  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.

  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 (1)

• satisfaction questionnaire

  After completion of IOL (either immediately after insertion of EAB or first PGE2 tablet).

Study Arms (2)

Personalized video group

EXPERIMENTAL

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

Other: Personalized video

Control group

NO INTERVENTION

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

Interventions

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.

Also known as: Video group

Personalized video group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Sensitivity to PGE2.
• Preterm labor.
• Premature rupture of membranes.
• Stillbirth.
• Elective pregnancy termination.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, Israel

RECRUITING

Related Publications (8)

• 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.

  PMID: 14699333 BACKGROUND

• 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.

  PMID: 16735538 BACKGROUND

• 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.

  PMID: 18769522 BACKGROUND

• National Collaborating Centre for Women and Children'sHealth. Induction of labour. London: NICE, 2008

  BACKGROUND

• Public Health Agency of Canada. Canadian Perinatal Health Report, 2008 edn. Ottawa: Public Health Agency of Canada, 2008

  BACKGROUND

• 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.

  PMID: 22032440 BACKGROUND

• 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.

  PMID: 10468063 BACKGROUND

• 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.

  PMID: 37951577 BACKGROUND

Central Study Contacts

Matan Friedman, MD

CONTACT

+972544210360; matan.friedman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 31, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)