Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial
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Protocol summary
Assess the Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women
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.
AssessEvaluate the Effecteffectiveness of Psychoeducational Intervention about Immune Healtha psychoeducational intervention on Perceived Physicalself-reported perceived physical and Psychological Health Among Working Womenpsychological immunity, health-promoting behaviors, personal control, stress, and fatigue among working women.
A randomized controlled trial, single-blind, case and control groups, pre-post intervention measurement.
An open-label, two-arm, parallel-group randomized controlled trial with blinded statistical analysis
AAn open-label, two-arm, parallel-group randomized controlled trial, single-blind, case and control groups, pre-post intervention measurement. with blinded statistical analysis
It will be conducted in five colleges affiliated with Damanhour University, Egypt.
Three colleges affiliated with Damanhour University, Egypt.
It will be conducted in fiveThree colleges affiliated with Damanhour University, Egypt.
Physical health: participants’ perceived physical immune status, health lifestyles, and personal control status measured by self-reported scales.
Psychological health: participants’ perceived psychological immunity status, stress, and fatigue levels measured by self-reported measures.
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.
Physical health: participantsParticipants’ perceived physical immune status, health lifestyles, and personal control status measured by self-reported scales. Psychological health: participantsParticipants’ perceived psychological immunity status, stress, and fatigue levels measured by self-reported measures.
General information
empty
60
60
empty
Year
year
Yes
No
1
Single blinded
Not blinded
singlnotbl
1
1
1
1
172
160
172160
2023-12-01, 1402/09/10
2024-07-01, 1403/04/11
20232024-1207-01 00:00:00
2023-12-30, 1402/10/09
2024-07-30, 1403/05/09
20232024-1207-30 00:00:00
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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.
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.
Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women at Damanhour University: A 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
EffectEffects of a Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological HealthImmunity, Stress, and Fatigue Among Working Women at Damanhour University: AAn Open-Label Randomized Controlled Trial
Effect of Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological Health Among Working Women at Damanhour University/Egypt: A 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
EffectEffects of a Psychoeducational Intervention about Immune Health on Perceived Physical and Psychological HealthImmunity, Stress, and Fatigue Among Working Women at Damanhour University/Egypt: AAn Open-Label Randomized Controlled Trial
Adult women working in the selected colleges for at least one year before initiating the study
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
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
Unwillingness to participate in this study
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.
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.
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The target group for this study will be women working in the selected colleges. They were selected using a cluster sampling technique (five colleges).
- A purposive sample of five colleges from Damanhour University will be selected based on having the highest number of female workers (Education, nursing, commerce, literature, and agriculture colleges) according to the latest data available from the university statistical center.
- A list will be created with the whole eligible female workers.
- The lottery system will be deployed by placing all the workers' names in a hat and then randomly selecting our sample without looking.
-Seventy percent of the female workers from each college will be recruited using the proportional allocation technique.
- Then they will be equally and randomly assigned to the intervention and comparison groups using a simple random method (Lottery method).
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.
The target group for this studyA purposive selection of three colleges will be women working in the selected colleges. They were selected using a cluster sampling technique (five colleges). - A purposive sample of five colleges from Damanhour University will be selectedmade based on having the highesttheir high number of female workers (Education, nursing, commerce, literature, and agriculture colleges) according to the latest data availableemployees. Eligible participants from the university statistical center. - A listthese colleges will be created with the whole eligible female workersassigned identification numbers. A computer- The lottery systemgenerated random number sequence will be deployed by placing allused to randomly allocate participants to either the workers' namesintervention or control group in a hat and then randomly selecting our sample without looking1:1 ratio. -Seventy percent of the female workers from each collegeAllocation concealment will be recruitedensured by using the proportional allocation techniquesealed, opaque, sequentially numbered envelopes prepared by an independent researcher not involved in participant recruitment or data collection. - Then theyEach envelope will be equallyopened sequentially only after a participant has provided informed consent, completed the baseline assessment, and randomly assigned tobeen enrolled, minimizing the intervention and comparison groups using a simple random method (Lottery method)risk of selection bias.
The investigator who conducted the statistical analysis will not engaged in the overall data collection process. The investigators who will collect the data enter them into the SPSS program using hidden codes from the analyzer. After finishing the data analysis process using predetermined codes, they will contacted to interpret the codes of both groups: intervention group "A" and comparison group "B."
The investigator who conducted the statistical analysis will not engaged in the overall data collection process. The investigators who will collect the data enter them into the SPSS program using hidden codes from the analyzer. After finishing the data analysis process using predetermined codes, they will contacted to interpret the codes of both groups: intervention group "A" and comparison group "B."
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Ethics committees
#1
2023-11-10, 1402/08/19
2023-06-23, 1402/04/02
2023-1106-1023 00:00:00
10-11-01-2023 EC
101-d-23-6-2023
10101-11d-0123-6-2023 EC
Intervention groups
#1
Intervention group: composed of 88 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 40-50 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 supporting, 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 accomplished 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 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 group: composed of 8880 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 30-40-50 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 supportingsupport, 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 accomplishedconducted after 3 months (posttest) to guarantee that the women maintained the learned activities and information by comparing the posttest results with the pretest results.
#2
Control group: They will be 88 women who will receive nothing. They initially will complete the pre-test and then the post-tests after 3 months, identically to the intervention group. In the end, they will receive the same educational content and assisted materials to preserve their moral and ethical rights and extend the benefits.
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.
Control group: They will be 8880 women who will receive nothing. They initially will complete the pre-test and then the post-teststest after 3 months, identically to the intervention group. InAt the end, they will receive the same educational content and assistedsupport materials to preserve their moral and ethical rights and extend the benefits.
Recruitment centers
#1
Name of recruitment center - English: Five colleges affiliated with Damanhour university Egypt
Name of recruitment center - Persian:
Full name of responsible person - English: Samiha Hamdi Sayed Ramadan
Full name of responsible person - Persian:
Street address - English: Damanhour, Elbehira, Governorate, Egypt
Street address - Persian:
City - English: Damahour
City - Persian:
Province: Elbehira Governorate
Country: Egypt
Postal code: 22511
Phone: +20 45 3311679
Fax:
Email: samihareda93@gmail.com
Web page address:
Name of recruitment center - English: Three colleges affiliated with Damanhour university Egypt
Name of recruitment center - Persian:
Full name of responsible person - English: Samiha Hamdi Sayed Ramadan
Full name of responsible person - Persian:
Street address - English: Damanhour, Elbehira, Governorate, Egypt
Street address - Persian:
City - English: Damahour
City - Persian:
Province: Elbehira Governorate
Country: Egypt
Postal code: 22511
Phone: +20 45 3311679
Fax:
Email: samihareda93@gmail.com
Web page address:
Name of recruitment center - English: FiveThree colleges affiliated with Damanhour university Egypt Name of recruitment center - Persian: Full name of responsible person - English: Samiha Hamdi Sayed Ramadan Full name of responsible person - Persian: Street address - English: Damanhour, Elbehira, Governorate, Egypt Street address - Persian: City - English: Damahour City - Persian: Province: Elbehira Governorate Country: Egypt Postal code: 22511 Phone: +20 45 3311679 Fax: Email: samihareda93@gmail.com Web page address:
Sharing plan
undecided
yes
undecidedyes
yes
undecided
yesundecided
After publication and will be available long life
After publication, it will be available for 5 years
After publication and, it will be available long lifefor 5 years
None
Contacting the corresponding author
NoneContacting the corresponding author
Protocol summary
Study aim
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.
Design
An open-label, two-arm, parallel-group randomized controlled trial with blinded statistical analysis
Settings and conduct
Three colleges affiliated with Damanhour University, Egypt.
Participants/Inclusion and exclusion criteria
Adult women working in the selected colleges for at least one year before initiating the study and enthusiastic to participate in this study
Intervention groups
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.
Main outcome variables
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.
General information
Reason for update
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.
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051555N5
Registration date:2023-12-30, 1402/10/09
Registration timing:prospective
Last update:2026-09-17, 1405/06/26
Update count:1
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Samiha Hamdi
Name of organization / entity
Dmanhour University, Faculty of Nursing
Country
Egypt
Phone
+20 45 3538264
Email address
samihareda93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-01, 1403/04/11
Expected recruitment end date
2024-07-30, 1403/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial
Public title
Effects of a Psychoeducational Intervention on Perceived Physical and Psychological Immunity, Stress, and Fatigue Among Working Women: An Open-Label Randomized Controlled Trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of the Faculty of Nursing- Damanhour University
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damanhour
Postal code
22511
Approval date
2023-06-23, 1402/04/02
Ethics committee reference number
101-d-23-6-2023
Health conditions studied
1
Description of health condition studied
Immunity and psychological health
ICD-10 code
F43.8
ICD-10 code description
Other reactions to severe stress
Primary outcomes
1
Description
perceived physical immune status
Timepoint
Before and 3 months after the intervention
Method of measurement
Immune Status Questionnaire (ISQ)
2
Description
perceived psychological immunity
Timepoint
Before and 3 months after the intervention
Method of measurement
Psychological-Immunity Scale (PIS)
3
Description
Perceived Stress level
Timepoint
Before and 3 months after the intervention
Method of measurement
Perceived Stress Scale (PSS)
4
Description
perceived fatigue level
Timepoint
Before and 3 months after the intervention
Method of measurement
Fatigue Assessment Scale (FAS)
5
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Three colleges affiliated with Damanhour university Egypt
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Postal code
22511
Phone
+20 45 3311679
Email
samihareda93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Damanhour University- Faculty of Nursing
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Postal code
22511
Phone
+20 45 3311679
Email
samihareda93@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Damanhour University- Faculty of Nursing
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Damanhour University- Faculty of Nursing
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Position
Assistant Professor of community health nursing
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Province
Elbehira Governorate
Postal code
22511
Phone
+20 45 3311679
Email
samihareda93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Damanhour University- Faculty of Nursing
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Province
Elbehira Governorate
Postal code
22511
Phone
+20 45 3311679
Email
samihareda93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Damanhour University- Faculty of Nursing
Full name of responsible person
Samiha Hamdi Sayed Ramadan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
Damanhour, Elbehira, Governorate, Egypt
City
Damahour
Province
Elbehira Governorate
Postal code
22511
Phone
+20 45 3311679
Email
samihareda93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Published research report that contains all the findings of the study.
When the data will become available and for how long
After publication, it will be available for 5 years
To whom data/document is available
for public
Under which criteria data/document could be used
for scientific use and public education
From where data/document is obtainable
Scientific-ranked health journal
What processes are involved for a request to access data/document