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.

Study Overview

• Status: Completed
• Conditions: Baby Blues Symptoms
• Intervention / Treatment: Behavioral: Education

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castilla
    • Toledo, Castilla, Spain
      • Esmeralda Santacruz-Salas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Women were informed of the study, and their participation was requested. Those who offered their willingness to participate signed the informed consent and were randomly assigned to the intervention group (IG) or the control group (CG). Randomization was performed using Microsoft Excel spreadsheet software. 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.	Behavioral: Education; 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.
No Intervention: Control Group; Women were informed of the study, and their participation was requested. Those who offered their willingness to participate signed the informed consent and were randomly assigned to the intervention group (IG) or the control group (CG). Randomization was performed using Microsoft Excel spreadsheet software. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baby Blues Symptoms Relief	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.	14 weeks

Collaborators and Investigators

• Sponsor: Universidad del Norte
• Collaborators: University of Wisconsin, Milwaukee; University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 13/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The IPD may be shared under anticipated requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No