"Sweet Expectation and Positive Thinking" the Use of the Mandala in the Induction of Labor (NCT06122168) | Clinical Trial Compass
CompletedNot Applicable
"Sweet Expectation and Positive Thinking" the Use of the Mandala in the Induction of Labor
Italy52 participantsStarted 2024-02-27
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy of an artistic tool, the mandala, in a population of pregnant women (nulliparous) undergoing labor induction.
The main questions it aims to answer are:
* Does using the mandala during labor induction improve the birth experience?
* Does the use of the mandala during the induction of labor improve the outcome of the birth and the demand for analgesia? Participants in the intervention group will receive standard treatment plus coloring mandala, those in the control group only standard treatment.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* pregnant women
* hospitalized for the need to induce labor for medical reasons
* single fetus in cephalic presentation
* gestational age ≥ 37 weeks
* having provided written consent to participate in the study
Exclusion Criteria:
* inductions requiring the initial use of oxytocin
* prenatal fetal complications such as severe intrauterine growth restriction (IUGR)
* suspicious or non-reassuring cardiotocography upon entry to the ward
* inability to understand the questionnaire and the information material provided
* all hospitalizations for primary causes other than induction
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Experience of childbirth through the Childbirth experience questionnaire (CEQ)