Psychological DistressNCT05307588
Psychological Distress During COVID-19 Pandemic
An observational study of Psychological Distress and COVID-19 Pandemic, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Design, sample, and setting This is a cross-sectional study using an Internet-based self-administered questionnaire of closed-ended questions and using convenience sampling. In total, 612 undergraduate students completed the survey in Mansoura University. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, COVID-19 Pandemic, Satisfaction
- How many people
- 1,056 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: - adults (18 years and above) in all regions of Egypt who were willing to participate in the study. The study adopted an online survey, and the study population may not reflect the actual pattern of the general population.
Who may be able to join
- All available adults can fill in online surveys.
Who cannot join
- Children under 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Satisfaction With Life and Psychological Distress During the COVID-19 Pandemic: An Egyptian Online Cross-sectional Study
Design, sample, and setting This is a cross-sectional study using an Internet-based self-administered questionnaire of closed-ended questions and using convenience sampling. In total, 612 undergraduate students completed the survey in Mansoura University.
Data collection Data was collected anonymously through an online questionnaire created using the technology of Google Forms provided by Google ™ and was constructed in Arabic language. The questionnaire consisted of three sections. The first section assessed students' baseline characteristics including sex, age, area of study, academic level, residence, marital status, family members infected, close people infected, and knowing someone who died of the infection.
The second section measured the psychosocial effects of COVID-19 pandemic using two instruments, University of California Los Angeles (UCLA) Loneliness Scale, version 324 and Depression Anxiety Stress Scale (DASS-21).19 The UCLA Loneliness Scale is a widely used self-report instrument of loneliness consisting of 20 items designed to measure both emotional as well as social loneliness. Response of each item was rated on a four-point scale from (1) never to (4) always felt as expressed in each item. Final score ranges from 20 to 80 with higher scores demonstrating higher feelings of loneliness. The scale's reliability was found to be high with alpha coefficients ranging from 0.89 to 0.94 for samples of students. The Arabic version of UCLA Loneliness Scale was used in the current study according to the Arabic translation in Egyptian culture by Daswqee.20 The correlation coefficients values were 0.76 for females and 0.74 for males.
Read the detailed description
Since December 2019, the novel coronavirus disease 2019 (COVID-19) has spread from Wuhan city to different areas in China and around the world. On 11 March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. On 14 February 2020, the Egyptian Ministry of Health reported the first case of COVID-19. To control the COVID-19 outbreak, the Egyptian government introduced preventive and containment measures with a partial closure starting on 25 March. On 31 March, Egypt pronounced 710 COVID-19 cases and 46 related deaths with a mortality rate of 6.48%. As on 06 June 2020, there were 1497 new cases with total cases of 32 612, a total of 1198 deaths and 8538 full recovery. Generally, several potential stressors were caused by the pandemic that might lead to psychological distress and life dissatisfaction. Individuals' overall assessments of their psychological wellbeing and quality of life are referred to as life satisfaction. Psychological distress takes the shape of a negative emotion, which contrasts with life contentment. It refers to people's unfavorable emotional reactions to several stimuli, which might include tension, dread, worry and psychological instability.
- Conditions
- Psychological Distress, COVID-19 Pandemic, Satisfaction
- Keywords
- psychosocial effects, COVID-19
- Medical subject headings
- COVID-19, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the levels of psychological distress.
A 10-item 5-point scale (10-50 score) is a self-report questionnaire used for measuring the levels of psychological distress. The respondents choose the most relevant response for them in the last 4 weeks. After summing scores, the range of 10-15, 16-21, 22-29 and 30-50 represent low, moderate, high and very high psychological distress, respectively
Measured: Within one week (06 to 13 June 2020).
Satisfaction with Life Scale
A self-report questionnaire intended to determine the level of satisfaction with life composed of 5-item rated on 7-point scale. After summing scores, the range of 5-9, 10-14, 15-19, 21-25, 26-30 and above 31 reflect extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, and extremely satisfied with life, respectively. A score of 20 reflects the impartial point on the scale.
Measured: Within one week (06 to 13 June 2020).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Jun 2020
- Primary completion20 Sep 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Loutfy, Beni-Suef University
- Investigators
- Ahmed Loutfy, PhD, Principal investigator, Department of Pediatric Nursing, Faculty of Nursing- Beni Suef University, EgyptMoustafa Saad, PhD, Principal investigator, Department of Gerontological Nursing, Faculty of Nursing-Mansoura University, EgyptAhmed Ali, PhD, Principal investigator, Department of Pediatric Nursing, Faculty of Nursing- Mansoura University, EgyptAbdel-Hady El-Gilany, PhD, Principal investigator, Department of Public Health and Preventive Medicine, Faculty of Medicine, Mansoura University, EgyptMohamed Zoromba, PhD, Principal investigator, Department of Psychiatric and Mental Health Nursing, Faculty of Nursing-Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307588
- Sponsor's protocol ID
- COVID-19
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
PubMed 32155789
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction With Life and Psychological Distress During the COVID-19 Pandemic: An Egyptian Online Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05307588
- Acronym / sponsor ID
- COVID-19
- Conditions
- Psychological Distress, COVID-19 Pandemic, Satisfaction
- Keywords
- psychosocial effects, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Design, sample, and setting This is a cross-sectional study using an Internet-based self-administered questionnaire of closed-ended questions and using convenience sampling. In total, 612 undergraduate students completed the survey in Mansoura University.
Data collection Data was collected anonymously through an online questionnaire created using the technology of Google Forms provided by Google ™ and was constructed in Arabic language. The questionnaire consisted of three sections. The first section assessed students' baseline characteristics including sex, age, area of study, academic level, residence, marital status, family members infected, close people infected, and knowing someone who died of the infection.
The second section measured the psychosocial effects of COVID-19 pandemic using two instruments, University of California Los Angeles (UCLA) Loneliness Scale, version 324 and Depression Anxiety Stress Scale (DASS-21).19 The UCLA Loneliness Scale is a widely used self-report instrument of loneliness consisting of 20 items designed to measure both emotional as well as social loneliness. Response of each item was rated on a four-point scale from (1) never to (4) always felt as expressed in each item. Final score ranges from 20 to 80 with higher scores demonstrating higher feelings of loneliness. The scale's reliability was found to be high with alpha coefficients ranging from 0.89 to 0.94 for samples of students. The Arabic version of UCLA Loneliness Scale was used in the current study according to the Arabic translation in Egyptian culture by Daswqee.20 The correlation coefficients values were 0.76 for females and 0.74 for males.
Detailed description
Since December 2019, the novel coronavirus disease 2019 (COVID-19) has spread from Wuhan city to different areas in China and around the world. On 11 March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. On 14 February 2020, the Egyptian Ministry of Health reported the first case of COVID-19. To control the COVID-19 outbreak, the Egyptian government introduced preventive and containment measures with a partial closure starting on 25 March. On 31 March, Egypt pronounced 710 COVID-19 cases and 46 related deaths with a mortality rate of 6.48%. As on 06 June 2020, there were 1497 new cases with total cases of 32 612, a total of 1198 deaths and 8538 full recovery. Generally, several potential stressors were caused by the pandemic that might lead to psychological distress and life dissatisfaction. Individuals' overall assessments of their psychological wellbeing and quality of life are referred to as life satisfaction. Psychological distress takes the shape of a negative emotion, which contrasts with life contentment. It refers to people's unfavorable emotional reactions to several stimuli, which might include tension, dread, worry and psychological instability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - adults (18 years and above) in all regions of Egypt who were willing to participate in the study. The study adopted an online survey, and the study population may not reflect the actual pattern of the general population.
Key inclusion criteria (1 listed)
- All available adults can fill in online surveys.
Key exclusion criteria (1 listed)
- Children under 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measuring the levels of psychological distress.
Time frame: Within one week (06 to 13 June 2020).
A 10-item 5-point scale (10-50 score) is a self-report questionnaire used for measuring the levels of psychological distress. The respondents choose the most relevant response for them in the last 4 weeks. After summing scores, the range of 10-15, 16-21, 22-29 and 30-50 represent low, moderate, high and very high psychological distress, respectively
Satisfaction with Life Scale
Time frame: Within one week (06 to 13 June 2020).
A self-report questionnaire intended to determine the level of satisfaction with life composed of 5-item rated on 7-point scale. After summing scores, the range of 5-9, 10-14, 15-19, 21-25, 26-30 and above 31 reflect extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, and extremely satisfied with life, respectively. A score of 20 reflects the impartial point on the scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 32155789Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Loutfy, PhD principal investigator
Department of Pediatric Nursing, Faculty of Nursing- Beni Suef University, Egypt
Moustafa Saad, PhD principal investigator
Department of Gerontological Nursing, Faculty of Nursing-Mansoura University, Egypt
Ahmed Ali, PhD principal investigator
Department of Pediatric Nursing, Faculty of Nursing- Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress and COVID-19 Pandemic, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the levels of psychological distress. (time frame: Within one week (06 to 13 June 2020).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.