Psychological Impact of Armed ConflictNCT06682338
Psychological Impact of Armed Conflict on Sudanese Diabetic Patients 2024
An observational study of Psychological Impact of Armed Conflict and Diabetes Complications, run by Rayan Jamal Yousif Khidir at 1 site in Sudan.
Trial summary
The study focused on Sudanese people with diabetes who experienced the ongoing war in Sudan. Some people were displaced and others were not. This would had an impact on their mental health. We have investigated this impact and any complications happened to them through Self-Administered questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Impact of Armed Conflict, Diabetes Complications
- How many people
- 117 participants
- Where
- 1 siteSudan
- Study dates
- 21 Apr 2024to 20 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sudanese Diabetic Patients above 18 years old, of both genders, from Khartoum and Gezira states.
Who may be able to join
None listed.
Who cannot join
- Non Diabetic, pre-existing psychological disorder
Trial locations and contacts
1 site in 1 country.
Sudan1 site
Research and Publication Office, Dental Alumni and Students Affairs, Karary University
Omdurman, Khartoum State
About this study
The study focused on Sudanese people with diabetes who experienced the ongoing war in Sudan. Some people were displaced and others were not. This would had an impact on their mental health. We have investigated this impact and any complications happened to them through Self-Administered questionnaire.
- Keywords
- DASS-21, Sudan, Psychological, Armed conflict, Diabetics
- Medical subject headings
- Diabetes Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Impact
Measured by Depression Anxiety Stress Scale-21 questionnaire.
Measured: April 2024 - July 2024
Secondary outcomes (1)
Diabetes complications
Measured by Self-Administered questionnaire containing questions about demographic data, patient's diabetes history and experienced complications
Measured: April 2024 - July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start21 Apr 2024
- Primary completion20 Jul 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Impact of Armed ConflictStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rayan Jamal Yousif Khidir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rayan Jamal Yousif Khidir, Research and Publication office
- Investigators
- Alaa MAK Alshykh, BDS, Study chair, Research and Publication Office, Dental Alumni and Students Affairs, Karary UniversityMai AA Balal, BDS, Study chair, Research and Publication Office, Dental Alumni and Students Affairs, Karary UniversityMohamed HA Nasr, PhD, Study director, International University of Africa / Omdurman Ahlia UniversityAfaf MH Jabir, BDS, Study chair, Federal Ministry of Health, Sudan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682338
- Sponsor's protocol ID
- 24004
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Armed Conflict on Sudanese Diabetic Patients 2024
- ClinicalTrials.gov ID
- NCT06682338
- Acronym / sponsor ID
- 24004
- Keywords
- DASS-21, Sudan, Psychological, Armed conflict, Diabetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Rayan Jamal Yousif KhidirUniversity, hospital or other
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 12 Nov 2024 (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.
The study focused on Sudanese people with diabetes who experienced the ongoing war in Sudan. Some people were displaced and others were not. This would had an impact on their mental health. We have investigated this impact and any complications happened to them through Self-Administered questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sudanese Diabetic Patients above 18 years old, of both genders, from Khartoum and Gezira states.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Non Diabetic, pre-existing psychological disorder
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
Psychological Impact
Time frame: April 2024 - July 2024
Measured by Depression Anxiety Stress Scale-21 questionnaire.
1 secondary outcome
Diabetes complications
Time frame: April 2024 - July 2024
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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.
Alaa MAK Alshykh, BDS study chair
Research and Publication Office, Dental Alumni and Students Affairs, Karary University
Mai AA Balal, BDS study chair
Research and Publication Office, Dental Alumni and Students Affairs, Karary University
Mohamed HA Nasr, PhD study director
International University of Africa / Omdurman Ahlia University
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 Impact of Armed Conflict and Diabetes Complications, run by Rayan Jamal Yousif Khidir at 1 site in Sudan.
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 0 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 12 Nov 2024. 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 Sudan. 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?
Psychological Impact (time frame: April 2024 - July 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.