Assessment of the Impact of Headache on the Employee Population of Libbs Pharmaceutical Ltd

NCT07295587 | Enrolling By Invitation

• 1 other identifier: LB2405
• Study Type: observational
• Target: 1,342
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the impact of primary headaches using data previously collected in a healthcare program conducted by Libbs with its employees. The study aims to identify the main types of headaches, assess their impact on work and quality of life, describe treatment modalities and healthcare services used, and analyze possible correlations between job position or sector and the occurrence of headaches, as well as their impact on productivity. This retrospective observational study analyzes secondary data collected from Libbs employees during a healthcare program designed to understand the impact of migraine on work productivity and daily activities. Data were obtained through validated questionnaires made available via an app. As this study involves the analysis of previously collected data, it does not provide direct benefits to participants. However, it contributes to a better understanding of migraine symptoms among Libbs employees, supports awareness of the risks of self-medication, and highlights the effects of headaches on daily routines and productivity. No therapeutic intervention is proposed in this study. Decisions regarding diagnosis, interventions, and treatments were made exclusively by the Dr. Cefaleia app team at the time of data collection, without any interference related to the development of this research. The HIT-6 score and the four WPAI outcomes will be analyzed: absenteeism (lost work time), presenteeism (impairment while working), overall work productivity loss (absenteeism plus presenteeism), and impairment in activities outside of work. This study provides an opportunity to expand the understanding of the relationship between working conditions, headaches, health, and productivity. The analysis may help identify epidemiological patterns and occupational or social risk factors associated with headaches, supporting future preventive strategies and workplace health initiatives aimed at improving quality of life and productivity.

Conditions

Migraine Headache; Migraine

Keywords

Migraine; headache; Dr.Cefaleia; Libbs

Outcome Measures

Primary Outcomes (1)

• Assessment of the impact of migraine on Libbs employees

  Given the observational nature of this study, the sample size for the study will not be calculated based on statistical considerations. Probabilistic and non-random sampling will be considered with the available data. The primary database contains data collected from 1,342 employees, out of a total of 2,957 employees at the company at the time. This is an observational, retrospective, descriptive study based on an anonymized secondary database, originating from data collected in a welfare program carried out by Libbs with its employees, who will response time on the form for entering data such as: age, gender, education, role, department, affiliate, presence of headache (yes or no)

  1 month

Study Arms (1)

Libbs´employees

All volunteer employees of Libbs Pharmaceuticals residing in all Brazilian regions will participate in this research. An online questionnaire will be applied to assess research subjects understanding of migraine and health habits.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Libbs´employees

You may qualify if:

• This analysis will include data from all employees who participated in this assistance program and made their data available in the Dr. Cefaleia app.

You may not qualify if:

• Data from participants whose questionnaires were not completed in full will be excluded.

Sponsors & Collaborators

• Libbs Farmacêutica LTDA: lead

Study Sites (1)

Libbs Farmacêutica LTDA.

São Paulo, São Paulo, 05036040, Brazil

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Renan B Domingues

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 19, 2025
• Study Start: January 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)