Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial

Evaluate the effectiveness of a psychoeducational intervention on self-reported perceived physical and psychological immunity, health-promoting behaviors, personal control, stress, and fatigue among working women.

An open-label, two-arm, parallel-group randomized controlled trial with blinded statistical analysis

Three colleges affiliated with Damanhour University, Egypt.

Adult women working in the selected colleges for at least one year before initiating the study and enthusiastic to participate in this study

The investigators will assess the women’s educational needs and their past and current immune and health status by completing the pre-test. They will construct the content of the psycho-educational intervention with multimedia-assisted materials. Topics will include relationship between physical and psychological health, definition, importance, and types of physical and psychological immunity, chronic fatigue syndrome and its relationship with psychological health status, and the role of lifestyle activities control and self-efficacy in improving immunity, exploring the symptoms and sources of stress and how to manage by using effective coping techniques: breathing exercises, relaxation techniques, sleep hygiene, social activities, and maintaining self-control over lifestyles. They will receive ten Face-to-Face psychoeducational sessions. During the first month, two sessions/week, while during the second month, one session/two weeks. Digital supporting and motivating messages were delivered. Post-test will be after 3 months.

Participants’ perceived physical immune status, health lifestyles, and personal control status measured by self-reported scales. Participants’ perceived psychological immunity status, stress, and fatigue levels measured by self-reported measures.

This update is requested to align the registry record with the final study protocol and the manuscript for publication. Specifically, we are updating the revised title statement requested by the journal, the target sample size to 160 to reflect our final sample size calculation (accounting for a 20% attrition rate), and the recruitment start date to July 2024 to reflect the actual timeline of the study. In addition, we are updating the ethical approval number and date and correcting the blinding status to 'Open label with blinded statistical analysis' to accurately reflect the trial design described in the manuscript.

A purposive selection of three colleges will be made based on their high number of female employees. Eligible participants from these colleges will be assigned identification numbers. A computer-generated random number sequence will be used to randomly allocate participants to either the intervention or control group in a 1:1 ratio. Allocation concealment will be ensured by using sealed, opaque, sequentially numbered envelopes prepared by an independent researcher not involved in participant recruitment or data collection. Each envelope will be opened sequentially only after a participant has provided informed consent, completed the baseline assessment, and been enrolled, minimizing the risk of selection bias.

Published research report that contains all the findings of the study.

After publication, it will be available for 5 years

for public

for scientific use and public education

Scientific-ranked health journal

Contacting the corresponding author

None