Induction of Labor Affected Fetus / NewbornNCT06375746
The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve.
A study testing Personalized video in people with Induction of Labor Affected Fetus / Newborn, run by Wolfson Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Personalized video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Sensitivity to PGE2.
- Preterm labor.
- Premature rupture of membranes.
- Stillbirth.
- Elective pregnancy termination.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson Medical Center
Holon
Matan Friedman
About this study
Official title: The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Personalized video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized videoOther
Also called Video group
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized video group | Experimental | In the video group patients will watch a personalized video prior to initiation of IOL in addition to standard counseling. Receives: Other: Personalized video |
| Control group | No intervention | Patients will receive only standard counselling prior to initiation of IOL. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: After completion of IOL (either immediately after insertion of EAB or first PGE2 tablet).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 May 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375746
- Sponsor's protocol ID
- 0091-22-WOMC
- Status last verified
- Jul 2024
- First submitted
- 16 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14699333Mackenzie IZ. Induction of labour at the start of the new millennium. Reproduction. 2006 Jun;131(6):989-98. doi: 10.1530/rep.1.00709.
PubMed 16735538Declercq 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.
PubMed 18769522National 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.
PubMed 22032440Nuutila 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.
PubMed 10468063Kleiner 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.
PubMed 37951577
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06375746
- Acronym / sponsor ID
- 0091-22-WOMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized video group | Experimental | Other: Personalized videoIn the video group patients will watch a personalized video prior to initiation of IOL in addition to standard counseling. |
| Control group | No intervention | –Patients will receive only standard counselling prior to initiation of IOL. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Sensitivity to PGE2.
- Preterm labor.
- Premature rupture of membranes.
- Stillbirth.
- Elective pregnancy termination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized videoAlso: Video groupAfter 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 | Personalized video group |
Primary outcome
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.
1 secondary outcome
satisfaction questionnaire
Time frame: After completion of IOL (either immediately after insertion of EAB or first PGE2 tablet).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 14699333Goffinet 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.
- Background: PubMed 16735538Mackenzie IZ. Induction of labour at the start of the new millennium. Reproduction. 2006 Jun;131(6):989-98. doi: 10.1530/rep.1.00709.
- Background: PubMed 18769522Declercq 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.
- BackgroundNational Collaborating Centre for Women and Children'sHealth. Induction of labour. London: NICE, 2008
- BackgroundPublic Health Agency of Canada. Canadian Perinatal Health Report, 2008 edn. Ottawa: Public Health Agency of Canada, 2008
- Background: PubMed 22032440Mozurkewich 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.
- Background: PubMed 10468063Nuutila 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.
- Background: PubMed 37951577Kleiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized video in people with Induction of Labor Affected Fetus / Newborn, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matan Friedman, MD (+972544210360, matan.friedman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375746, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.