Clinical trial NCT06122168: "Sweet Expectation and Positive Thinking" the Use of the Mandala in the Induction of Labor
Official title: "Sweet Expectation and Positive Thinking" the Use of the Mandala in the Induction of Labor: a Randomized Clinical Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nulliparity
Induction of Labor Affected Fetus / Newborn
Keywords: nulliparity
mandala
experience
childbirth
Lead sponsor: Ospedale degli Infermi di Biella
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single center, prospective, randomized trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Labor induction is one of the most frequent gestures in the daily clinical practice of an obstetrics department. In recent decades there has been an increase in this practice, the reasons for which are not entirely understandable, but being a medical intervention it must be as appropriate as possible. The induction of labor is implemented in order to interrupt the evolution of the pregnancy and the goal is to obtain an active labor in conditions of maternal-fetal well-being (SIGO Guidelines 2022). WHO recommends that women's experiential experience with respect to their nursing care be considered of equal importance to clinical care. A positive birth experience is a good indicator for women who decide to have more children and is positively related to the establishment of the mother-infant bond as well as maternal confidence in breastfeeding. Consequently, a negative birth experience in addition to negatively influencing the decision to have another child, also affects the well-being of the mother and leads to high levels of anxiety. A study has shown that the feeling of control and participation in choosing one's birth experience is related to a positive birth experience. From the point of view of the perception of safety and the sense of participation during labour, induced patients appear to have lower levels than women in spontaneous labour, this should sensitize the midwives and health professionals involved in the process, to provide better support.

Study design: randomized clinical pilot study in parallel groups, patients will be assigned to the two groups through the sealed envelope method.

Intervention: Intervention group. Patients assigned to this group will receive standard induction management plus mandala delivery. The standard management provides, upon admission, a verbal interview with the doctor and midwife regarding the labor induction procedure (Time 1), specifically:

* explanation of the diagnosis requiring labor induction;
* induction times;
* induction methods;
* type of assistance and obstetric/medical surveillance;
* possibility of support from the partner;
* information related to the stay in the ward;
* verbal and written information on the study and request for participation. Time 1 will end with the signing of the consent to participate in the study. Time 2, shortly before the induction, there is a time dedicated to written informed consent relating to the induction, with explanations of possible complications. Time 3: once the induction is over, the patient will be invited to return to the hospital room where the time of the intervention will start, with the delivery of the mandala and colours. During the phases preceding the start of labour, except for the time dedicated to coloring the mandala, the patient will be subjected to standard care management, as required by the ward induction protocol. Control group: will follow all the standard management of hospitalization, informed consent and post induction (time 1, 2 and 3) foreseen for the intervention group, but will not receive the mandala.

Sample size estimation: based on literature data which report an average CEQ value of 2.9 in nulliparous women and calculating the variance on the basis of a standard deviation equal to 0.6, with a 95% confidence level and a power of 80%, it is estimated that 49 patients need to be enrolled to observe a difference between CEQ scale scores of 0.34 points.

Allocation: in order to be able to assign the patients to one of the two groups, sealed envelopes will be generated, equal to the number of participants expected in the study. Inside the envelope it will be stated which group the patient will participate in by the wording "CONTROL" or "INTERVENTION", it will not be possible to change the allocation sequence based on the patient's or team's preferences. The sealed envelopes will be created by a team separate from the one that will take care of the data, specifically by the person set out as responsible for the "Conceptualization, methodology, writing and review" part, who will not participate in any way in the clinical management- patient care and care and data management. Once the envelopes have been generated, which will be identical in shape, color and content, so as to make them unrecognizable, they will be mixed, delivered and stored in a locked drawer that can only be opened by the team designated as responsible for data care. After opening the sealed envelope, the allocation to one of the two groups will be established by the doctor who will also establish the need for hospitalisation, diagnose the need for induction and have the consent to participate in the study signed. The sealed envelope will be delivered by the team responsible for data care, only after completing all the procedures foreseen in time 1, and shortly before delivering the patient to the inpatient ward.

Recruitment: recruitment to the study will take place only after verification of the inclusion criteria set out in the following protocol. There will be an initial selection by the obstetrics/gynecological staff, made aware of all the parts of the protocol, who will be able to recognize a patient with the characteristics suitable for participation in the study. The team indicated as "project and investigation administrator" will then be contacted, which will have the final responsibility for including or excluding the patient, after careful evaluation of all the criteria set out.

Delivery of the intervention: once the hospitalization phases, foreseen at time 1 and the recruitment and allocation phases have been completed, the patient will be taken to the hospital ward, in this phase the ward midwives will be informed with respect to the group to which they belong, so that they can the mandala, if it is the intervention group, vice versa the standard management will start. At the end of the hospitalization, the medical records of the patients in the study will be handed over to the team responsible for data care.

Data management A specially created database will be compiled, in which the main characteristics of the enrolled patients will be collected (age, week of gestation, reason for induction, presence of partners, educational qualifications, etc.). Furthermore, the data of the answers to the anonymous questionnaire and those relating to the secondary outcomes will be collected, through the patient's medical record, which will be kept separately, in a locked drawer, by the team responsible for data care. The team designated for "formal, methodological and data management analysis" will take care of compiling the database. The patients, within the database, will be identified as group A and B; Once the study and the compilation of the database have been completed, this will be delivered to the results evaluation team which will therefore be blinded, not being able to recognize whether group A and B belong to control or intervention.

Blindness

* Allocation: will take place blindly as specified in the previous paragraph;
* Study participants: they will not be blinded, since the administration of the mandala cannot be hidden;
* Assistance providers: they will not be blinded for the above reason;
* Outcome evaluators and data analysis: blinded thanks to data entry with group A and B methods and not as a control and intervention.

Statistical analysis plan: possible confounding variables will be collected in a questionnaire at baseline, and, in the case of statistically significant differences between the experimental and control group, an adjustment will be made by stratification or logistic regression.

Primary outcome: the difference between the mean of the CEQ scores in the two groups and the relative standard deviation will be estimated, in order to obtain an evidence-based measure based on the difference between means weighted by the sample size with the relative 95% confidence intervals (weighted mean difference - WMD); the estimate will be made both for the overall score and for the specific area.

Secondary outcomes: the results will be presented as cumulative incidences in the two groups and relative risks with the relative 95% confidence intervals for the dichotomous variables; for the continuous variables, means will be presented with the relative standard deviations in the two groups and the WMD with relative 95% confidence interval will be used as a summary measure.

Eligibility criteria: 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

Primary outcomes:
measure: Experience of childbirth through the Childbirth experience questionnaire (CEQ)
timeFrame: 24 hours after giving birth
Secondary outcomes:
measure: Evaluate the outcome of the birth through the patient's medical records, specifically whether it ended in spontaneous birth or cesarean section or instrumental birth.
timeFrame: up to 24 weeks
measure: Use and request by the patient in the study of epidural analgesia during labor
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Ponderano
country: Italy
facility: Bianca Masturzo Ospedale degli Infermi
state: Biella
Study officials:
affiliation: Ospedale degli Infermi di Biella
name: bianca masturzo, Md, PhD
role: PRINCIPAL_INVESTIGATOR
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