"Sweet Expectation and Positive Thinking" the Use of the Mandala in the Induction of Labor

NCT06122168 | Completed

• 1 other identifier: CE069/2023
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Nulliparity; Induction of Labor Affected Fetus / Newborn

Keywords

nulliparity; mandala; experience; childbirth

Outcome Measures

Primary Outcomes (1)

• Experience of childbirth through the Childbirth experience questionnaire (CEQ)

  Evaluate whether the use of the mandala affects the woman's experience with birth through a questionnaire consisting of 22 questions, the Childbirth experience questionnaire (CEQ). The rating range is 1 to 4 with higher ratings reflecting more positive experiences.

  24 hours after giving birth

Secondary Outcomes (2)

• 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.

  up to 24 weeks

• Use and request by the patient in the study of epidural analgesia during labor

  up to 24 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

Standard induction handling plus mandala delivery. The standard management involves, upon admission, a verbal interview with the doctor and midwife regarding the labor induction procedure (Time 1) 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 complete, the patient will be invited to return to the hospital room and where the time for 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.

Other: Mandala

Control Group

ACTIVE COMPARATOR

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.

Other: Standard care

Interventions

Mandala OTHER

verbal interview, standard health care, sheet of paper showing a mandala to be colored at will

Intervention Group

Standard care OTHER

verbal interview and standard health care

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bianca Masturzo: lead

Study Sites (1)

Bianca Masturzo Ospedale degli Infermi

Ponderano, Biella, 13875, Italy

Location

Related Publications (12)

• Tuncalp Ӧ, Were WM, MacLennan C, Oladapo OT, Gulmezoglu AM, Bahl R, Daelmans B, Mathai M, Say L, Kristensen F, Temmerman M, Bustreo F. Quality of care for pregnant women and newborns-the WHO vision. BJOG. 2015 Jul;122(8):1045-9. doi: 10.1111/1471-0528.13451. Epub 2015 May 1. No abstract available.

  PMID: 25929823 BACKGROUND

• Mercer RT, Ferketich SL. Maternal-infant attachment of experienced and inexperienced mothers during infancy. Nurs Res. 1994 Nov-Dec;43(6):344-51.

  PMID: 7971298 BACKGROUND

• Waldenstrom U, Hildingsson I, Ryding EL. Antenatal fear of childbirth and its association with subsequent caesarean section and experience of childbirth. BJOG. 2006 Jun;113(6):638-46. doi: 10.1111/j.1471-0528.2006.00950.x.

  PMID: 16709206 BACKGROUND

• Cook K, Loomis C. The Impact of Choice and Control on Women's Childbirth Experiences. J Perinat Educ. 2012 Summer;21(3):158-68. doi: 10.1891/1058-1243.21.3.158.

  PMID: 23730127 BACKGROUND

• Coates R. Attitudes of pregnant women and healthcare professionals to labour induction and obtaining consent for labour induction. Best Pract Res Clin Obstet Gynaecol. 2021 Nov;77:64-75. doi: 10.1016/j.bpobgyn.2021.08.008. Epub 2021 Aug 27.

  PMID: 34625350 BACKGROUND

• Coates D, Goodfellow A, Sinclair L. Induction of labour: Experiences of care and decision-making of women and clinicians. Women Birth. 2020 Feb;33(1):e1-e14. doi: 10.1016/j.wombi.2019.06.002. Epub 2019 Jun 15.

  PMID: 31208865 BACKGROUND

• Dupont C, Blanc-Petitjean P, Cortet M, Gaucher L, Salome M, Carbonne B, Ray CL. Dissatisfaction of women with induction of labour according to parity: Results of a population-based cohort study. Midwifery. 2020 May;84:102663. doi: 10.1016/j.midw.2020.102663. Epub 2020 Feb 14.

  PMID: 32092607 BACKGROUND

• Schwarz C, Gross MM, Heusser P, Berger B. Women's perceptions of induction of labour outcomes: Results of an online-survey in Germany. Midwifery. 2016 Apr;35:3-10. doi: 10.1016/j.midw.2016.02.002. Epub 2016 Feb 8.

  PMID: 27060393 BACKGROUND

• Place K, Kruit H, Rahkonen L. Comparison of primiparous women's childbirth experience in labor induction with cervical ripening by balloon catheter or oral misoprostol - a prospective study using a validated childbirth experience questionnaire (CEQ) and visual analogue scale (VAS). Acta Obstet Gynecol Scand. 2022 Oct;101(10):1153-1162. doi: 10.1111/aogs.14433. Epub 2022 Aug 7.

  PMID: 35933726 BACKGROUND

• Evans K, Sands G, Spiby H, Evans C, Pallotti P, Eldridge J. A systematic review of supportive interventions to promote women's comfort and well-being during induction of labour. J Adv Nurs. 2021 May;77(5):2185-2196. doi: 10.1111/jan.14711. Epub 2020 Dec 14.

  PMID: 33314297 BACKGROUND

• Adler K, Rahkonen L, Kruit H. Maternal childbirth experience in induced and spontaneous labour measured in a visual analog scale and the factors influencing it; a two-year cohort study. BMC Pregnancy Childbirth. 2020 Jul 21;20(1):415. doi: 10.1186/s12884-020-03106-4.

  PMID: 32693773 BACKGROUND

• Joensuu JM, Saarijarvi H, Rouhe H, Gissler M, Ulander VM, Heinonen S, Torkki P, Mikkola TS. Maternal childbirth experience and induction of labour in each mode of delivery: a retrospective seven-year cohort study of 95,051 parturients in Finland. BMC Pregnancy Childbirth. 2022 Jun 23;22(1):508. doi: 10.1186/s12884-022-04830-9.

  PMID: 35739476 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• bianca masturzo, Md, PhD

  Ospedale degli Infermi di Biella

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department of Gynaecology and Obstetrics

Model Details: single center, prospective, randomized trial

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 8, 2023
• Study Start: February 27, 2024
• Primary Completion: February 16, 2025
• Study Completion: February 16, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: At the end of the study
• Access Criteria: Participants centers and to other researchers who will ask the managers for details of the study data

Locations

IT (1)