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IRCT20210612051555N5 IRCT 2023-12-30 Damanhour University- Faculty of Nursing Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial 2024-07-01 anticipated 160 Complete https://irct.ir/trial/73883 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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. N/A Immunity and psychological health. Intervention 1: Intervention group: composed of 80 women who will receive the preplanned intervention. They will receive a total of ten Face-to-Face psychoeducational sessions. The average duration for each session will be 30-40 minutes and will be arranged at the convenience of the working women in each college with adequate meeting space and needed arrangements. During the first month, eight sessions will be delivered, two sessions per week, while during the second month, one session will be conducted every two weeks. In between the sessions, digital support, motivating, and follow-up messages will be delivered through the created WhatsApp group on a day-to-day basis. Finally, the follow-up will be conducted after 3 months (posttest) to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results. Intervention 2: Control group: They will be 80 women who will receive nothing. They initially will complete the pre-test and then the post-test after 3 months, identically to the intervention group. At the end, they will receive the same educational content and support materials to preserve their moral and ethical rights and extend the benefits. Yes - There is a plan to make this available What will be shared: Published research report that contains all the findings of the study. When: After publication, it will be available for 5 years To whom: for public Conditions: for scientific use and public education Where to obtain: Scientific-ranked health journal How to obtain: Contacting the corresponding author Comments: None
public Samiha Hamdi Sayed Ramadan
Damanhour, Elbehira, Governorate, Egypt
Damahour Egypt 22511 +20 45 3311679 samihareda93@gmail.com Damanhour University- Faculty of Nursing scientific Samiha Hamdi Sayed Ramadan
Damanhour, Elbehira, Governorate, Egypt
Damahour Egypt 22511 +20 45 3311679 samihareda93@gmail.com Damanhour University- Faculty of Nursing Egypt Adult women (20 years or more) working in the selected colleges for at least one year before initiating the study Access to a smartphone with WhatsApp Ability to read and understand Arabic 20 years 60 years Female Unwillingness to participate in this study Participation in another structured educational or psychological program during the study period Severe psychiatric illness requiring ongoing specialized treatment (as self-reported) Inability to attend the scheduled intervention sessions. F43.8 Other reactions to severe stress Behavior Other Intervention group: composed of 80 women who will receive the preplanned intervention. They will receive a total of ten Face-to-Face psychoeducational sessions. The average duration for each session will be 30-40 minutes and will be arranged at the convenience of the working women in each college with adequate meeting space and needed arrangements. During the first month, eight sessions will be delivered, two sessions per week, while during the second month, one session will be conducted every two weeks. In between the sessions, digital support, motivating, and follow-up messages will be delivered through the created WhatsApp group on a day-to-day basis. Finally, the follow-up will be conducted after 3 months (posttest) to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results. Control group: They will be 80 women who will receive nothing. They initially will complete the pre-test and then the post-test after 3 months, identically to the intervention group. At the end, they will receive the same educational content and support materials to preserve their moral and ethical rights and extend the benefits. Perceived physical immune status. Timepoint: Before and 3 months after the intervention. Method of measurement: Immune Status Questionnaire (ISQ). Perceived psychological immunity. Timepoint: Before and 3 months after the intervention. Method of measurement: Psychological-Immunity Scale (PIS). Perceived Stress level. Timepoint: Before and 3 months after the intervention. Method of measurement: Perceived Stress Scale (PSS). Perceived fatigue level. Timepoint: Before and 3 months after the intervention. Method of measurement: Fatigue Assessment Scale (FAS). Perceived level of Health Lifestyle and Personal Control. Timepoint: Before and 3 months after the intervention. Method of measurement: Health Lifestyle and Personal Control Questionnaire (HLPCQ). Damanhour University- Faculty of Nursing Approved 2023-06-23 Ethic's committee of the Faculty of Nursing- Damanhour University Damanhour, Elbehira, Governorate, Egypt Damanhour Damanhour Egypt