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

• Sponsor: Universidad del Norte (Other)
• Overall Status: Completed
• CT.gov ID: NCT06056700
• Collaborator: University of Wisconsin, Milwaukee (Other), University of Castilla-La Mancha (Other)
• Enrollment: 71
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Baby Blues Symptoms	Behavioral: Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Emotional Intelligence In Pregnancy and the Puerperium and Baby Blues Symptoms: A Randomized Clinical Trial
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Dec 30, 2018
• Actual Study Completion Date: Dec 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Baby Blues Symptoms Relief [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Esmeralda Santacruz-Salas	Toledo	Castilla	Spain

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidad del Norte
• ClinicalTrials.gov Identifier: NCT06056700
• Other Study ID Numbers: 13/2015
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 28, 2023