Indication for Modification of Patient Psychological StatusNCT02792374
Psychological Profile of Dental Patients
An observational study of Indication for Modification of Patient Psychological Status, run by Talebian, Alireza, M.D..
Trial summary
The objective of this descriptive investigation was to evaluate the psychological profile of dental patients in three levels: global level, the dimensional level, and the discrete symptom level and to compare it with a control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Indication for Modification of Patient Psychological Status
- What is being tested?
- Psychological Measurement
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients who referred to a dental office in Isfahan city, Iran. The chief complaints of them were not the same.
Who may be able to join
- Must:
- be ≥ 18 years old and have high school degree or higher
Who cannot join
- insufficient verbal capacity to comprehend the items of the questionnaire.
About this study
Official title: Psychological Profile of Dental Patients. A Case Control Study
The objective of this descriptive investigation was to evaluate the psychological profile of dental patients in three levels: global level, the dimensional level, and the discrete symptom level and to compare it with a control group.
Read the detailed description
Many people is afraid of dental treatment specially local anesthesia and do not refer to dental clinics until they are obliged due to dental pain. There are so many articles in the literature about dental phobia and fear of anesthetic injection. Due to these evidences, dental people are supposed to show elevated psychological dimensions such as anxiety, and somatization.
We are going to know which psychological dimensions of dental patients may be elevated when they refer to dental clinics.
- Being tested
- Psychological Measurement
- Keywords
- Dental patients, Psychological Profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological MeasurementOther
Also called psychological assessment of the subjects
Measurement of psychological status in three levels: discrete symptom level, dimensional level, global level as measured by the scale
| Study group | Role | What they receive |
|---|---|---|
| Dental patients group | Psychological measurement is done when they refer to a dental clinic. Receives: Other: Psychological Measurement | |
| Control group | Psychological measurement is done when they refer to a dental clinic. Receives: Other: Psychological Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine psychological dimensions measured using a self-administered scale (SCL-90-R)
The subjects are supposed to consider the last week and answer all questions of psychological questionnaire.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJan 2012
- Primary completionApr 2015
- Study completionJun 2015
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 Indication for Modification of Patient Psychological StatusStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talebian, Alireza, M.D.
- Responsible party
- Principal investigator, Talebian, Alireza, M.D., Talebian, Alireza, M.D.
- Investigators
- Alireza Talebian, PhD, Principal investigator, Cheif
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792374
- Sponsor's protocol ID
- 1818193574
- Status last verified
- Jun 2016
- First submitted
- 26 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Eli I, Baht R, Kozlovsky A, Rosenberg M. The complaint of oral malodor: possible psychopathological aspects. Psychosom Med. 1996 Mar-Apr;58(2):156-9. doi: 10.1097/00006842-199603000-00010.
PubMed 8849633
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Profile of Dental Patients. A Case Control Study
- ClinicalTrials.gov ID
- NCT02792374
- Acronym / sponsor ID
- 1818193574
- Keywords
- Dental patients, Psychological Profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Talebian, Alireza, M.D.
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Jun 2016 (estimated)
- 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 objective of this descriptive investigation was to evaluate the psychological profile of dental patients in three levels: global level, the dimensional level, and the discrete symptom level and to compare it with a control group.
Detailed description
Many people is afraid of dental treatment specially local anesthesia and do not refer to dental clinics until they are obliged due to dental pain. There are so many articles in the literature about dental phobia and fear of anesthetic injection. Due to these evidences, dental people are supposed to show elevated psychological dimensions such as anxiety, and somatization.
We are going to know which psychological dimensions of dental patients may be elevated when they refer to dental clinics.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental patients group | – | Other: Psychological MeasurementPsychological measurement is done when they refer to a dental clinic. |
| Control group | – | Other: Psychological MeasurementPsychological measurement is done when they refer to a dental clinic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who referred to a dental office in Isfahan city, Iran. The chief complaints of them were not the same.
Key inclusion criteria (2 listed)
- be ≥ 18 years old and have high school degree or higher
Key exclusion criteria (1 listed)
- insufficient verbal capacity to comprehend the items of the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological MeasurementAlso: psychological assessment of the subjectsMeasurement of psychological status in three levels: discrete symptom level, dimensional level, global level as measured by the scale | Other | Control group, Dental patients group |
Primary outcome
Nine psychological dimensions measured using a self-administered scale (SCL-90-R)
Time frame: through study completion, an average of 1 year
The subjects are supposed to consider the last week and answer all questions of psychological questionnaire.
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 7 Jun 2016.
- Results publication: PubMed 8849633Eli I, Baht R, Kozlovsky A, Rosenberg M. The complaint of oral malodor: possible psychopathological aspects. Psychosom Med. 1996 Mar-Apr;58(2):156-9. doi: 10.1097/00006842-199603000-00010.
- Click here for more information about this study: The complaint of oral malodorLink provided by the sponsor.
- 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.
Alireza Talebian, PhD principal investigator
Cheif
Questions about this trial
What is this clinical trial studying?
An observational study of Indication for Modification of Patient Psychological Status, run by Talebian, Alireza, M.D..
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 2 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 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Nine psychological dimensions measured using a self-administered scale (SCL-90-R) (time frame: through study completion, an average of 1 year). 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 NCT02792374, 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 7 Jun 2016.