Completed

NCT Number: NCT06056700

Emotional Intelligence In Pregnancy and the Puerperium and Baby Blues Symptoms: A Randomized Clinical Trial

Background: Emotional intelligence pertains to the capacity for making decisions and adjusting to life's fluctuations, an attribute influenced by emotional conditions. Several scenarios impact nearly 80% of females, influencing their nurturing abilities. This study aimed to analyze the effectiveness of the "Happy in My Maternity" project in reducing baby blues symptoms in postnatal women. Methods: Employing a randomized clinical trial, hybrid interventions based on mobile application and i-person were conducted as part of an educational and emotional regulation curriculum. Enrollment encompassed the well-being of women. The program retained thirty-five participants, with thirty-four constituting the control cluster. The Trait-Meta Mood Scale (TMMS-24) questionnaire evaluation was administered to gauge emotional intelligence.

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Key information

Conditions

Baby Blues Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Esmeralda Santacruz-Salas

Toledo, Castilla, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

i) to have between 28 and 38 weeks of pregnancy, ii) pregnant women with follow-up and control at the participant hospital iii) women who signed their consent to participate in the study

Exclusion criteria

i) Women with high-risk pregnancies ii) Women suffering from psychiatric disorders before pregnancy such as anxiety, affective or disruptive behavior disorders

Treatment and study plan

Education

Behavioral

All study follow-up information was collected through this app. The information offered to all the mothers through the mobile application contained a welcome message, contact data, sociodemographic and clinical variables, and access to the TMM-24 questionnaire. However, the GI through the app had access to complementary information content regarding the CG. The mothers of the IG had additional training material related to the first two prenatal face-to-face training sessions and new information during the postnatal period throughout consecutive weeks 1 to 8.

Primary outcomes

Baby Blues Symptoms Relief

Time frame: 14 weeks

Baby Blues Symptoms Relief compared with the control group. These measurements were based on the Trait-Meta Mood Scale (TMMS-24) questionnaire evaluation for gauging emotional intelligence.

Sponsors and collaborators

Lead sponsor

Universidad del Norte

Other

Collaborators

University of Castilla-La Mancha
University of Wisconsin, Milwaukee

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Sep 28, 2023
Registry last updated: Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.