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

NCT06056700 | Completed

• 1 other identifier: 13/2015
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Baby Blues Symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad del Norte: lead
• University of Wisconsin, Milwaukee: collaborator
• University of Castilla-La Mancha: collaborator

Study Sites (1)

Esmeralda Santacruz-Salas

Toledo, Castilla, Spain

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: August 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

ES (1)