ClaustrophobiaNCT05876117
Premedication for Claustrophobic Patients for MRI Scan
An observational study of Claustrophobia, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
Trial summary
Claustrophobia is an irrational fear of restriction and suffocation. It is a specific phobia, according to DSM 5. Claustrophobic patients may fear that restriction of their limbs will hinder their ability to move quickly towards safety. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Claustrophobia
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult claustrophobic patients who are undergoing MRI scan as part of chronic pain management. Previous incomplete MRI because of claustrophobia.
Who may be able to join
- diagnosed with claustrophobia
- previous incomplete MRI because of claustrophobia
- adult patients
- good treatment compliance
- reliable Claustrophobia Questionnaire (CLQ) diary
- reliable General Anxiety Disorder Questionnaire (GAD) diary
- informed consent for diary review
- consent for clinical record quality assurance review
Who cannot join
- poor treatment compliance
- cognitive disorder
- inability to provide consent
- major neuropsychiatric disorder
- unreliable diary
- cannabis use
Show all 9Show fewer
- excessive alcohol intake
- previous adverse/allergic reactions to clonidine
- previous adverse/allergic reactions to lorazepam
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Salem Anaesthesia Pain Clinic
Surrey, British Columbia, V3S 7J1
Olu Bamgbade, MD,FRCPC, +17786286600, salem.painclinic@gmail.com
About this study
Official title: Clonidine and Lorazepam Premedication for Claustrophobic Patients During MRI Scan
Claustrophobia is an irrational fear of restriction and suffocation. It is a specific phobia, according to DSM 5. Claustrophobic patients may fear that restriction of their limbs will hinder their ability to move quickly towards safety. MRI may trigger claustrophobia, because this diagnostic procedure involves a patient laying in a narrow tube. Premedication before MRI scan may occasionally reduce claustrophobia.
Prospective observational crossover study of claustrophobic patients who are undergoing MRI scan. At alternate MRI scan sessions, each patient receives rotational premedication using Lorazepam 1mg; or Clonidine tablet 0.2mg; or combined Clonidine 0.2mg + Lorazepam 1mg.
Patient will use Claustrophobia Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. CLQ is a patient-administered tool used to assess claustrophobia. In addition, patient will use General Anxiety Disorder Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. GAD-7 is a patient-administered tool that is used to assess anxiety.
Read the detailed description
Claustrophobia is an irrational fear of constraint, restriction, immobility, smothering and suffocation. Claustrophobia is a specific phobia, according to the Diagnostic and Statistical Manual 5 (DSM 5). The disorder affects 5% of the general population. Claustrophobic patients may fear that the restriction of their limbs will hinder their ability to move quickly towards perceived safety. Magnetic resonance imaging (MRI) may trigger claustrophobia, because this diagnostic procedure involves a patient staying immobile in a narrow and noisy tube. Anxiolytic premedication before MRI scan, using Lorazepam, may occasionally help to reduce claustrophobia.
This is a prospective observational crossover study of claustrophobic adult patients who are undergoing MRI scan as part of chronic pain management. At alternate MRI scan sessions, each patient receives rotational premedication using Lorazepam 1mg; or Clonidine tablet 0.2mg; or combined Clonidine 0.2mg + Lorazepam 1mg.
The patient will use the Claustrophobia Questionnaire (CLQ), a special validated tool, to collect data on the days before and after each MRI scan. The CLQ is a patient-administered tool that is used to record the severity and presence of claustrophobia symptoms, on a measurement range of 0 to 104. A change in the CLQ scores by 12-points is considered significant. In addition, the patient will use the General Anxiety Disorder Questionnaire (GAD-7), a special validated tool, to collect data on the days before and after each MRI scan. The GAD-7 is a patient-administered tool that is used to record the severity and presence of anxiety symptoms, on a measurement range of 0 to 21. A change in the GAD-7 scores by 3-points is considered significant.
Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.
- Conditions
- Claustrophobia
- Keywords
- Claustrophobia MRI
- Medical subject headings
- Claustrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Claustrophobic adult patients | Claustrophobic adult patients who are undergoing MRI scan as part of chronic pain management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of completion of MRI scan
Patient is calm and cooperative, completes MRI scan
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start4 Jul 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaustrophobiaStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olu Bamgbade, MD,FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876117
- Sponsor's protocol ID
- SalemAnes2022 MRI Premedicate
- Status last verified
- Jan 2025
- First submitted
- 5 May 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonidine and Lorazepam Premedication for Claustrophobic Patients During MRI Scan
- ClinicalTrials.gov ID
- NCT05876117
- Acronym / sponsor ID
- SalemAnes2022 MRI Premedicate
- Conditions
- Claustrophobia
- Keywords
- Claustrophobia MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 May 2023 (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.
Claustrophobia is an irrational fear of restriction and suffocation. It is a specific phobia, according to DSM 5. Claustrophobic patients may fear that restriction of their limbs will hinder their ability to move quickly towards safety. MRI may trigger claustrophobia, because this diagnostic procedure involves a patient laying in a narrow tube. Premedication before MRI scan may occasionally reduce claustrophobia.
Prospective observational crossover study of claustrophobic patients who are undergoing MRI scan. At alternate MRI scan sessions, each patient receives rotational premedication using Lorazepam 1mg; or Clonidine tablet 0.2mg; or combined Clonidine 0.2mg + Lorazepam 1mg.
Patient will use Claustrophobia Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. CLQ is a patient-administered tool used to assess claustrophobia. In addition, patient will use General Anxiety Disorder Questionnaire, a validated tool, to collect data on the days before and after each MRI scan. GAD-7 is a patient-administered tool that is used to assess anxiety.
Detailed description
Claustrophobia is an irrational fear of constraint, restriction, immobility, smothering and suffocation. Claustrophobia is a specific phobia, according to the Diagnostic and Statistical Manual 5 (DSM 5). The disorder affects 5% of the general population. Claustrophobic patients may fear that the restriction of their limbs will hinder their ability to move quickly towards perceived safety. Magnetic resonance imaging (MRI) may trigger claustrophobia, because this diagnostic procedure involves a patient staying immobile in a narrow and noisy tube. Anxiolytic premedication before MRI scan, using Lorazepam, may occasionally help to reduce claustrophobia.
This is a prospective observational crossover study of claustrophobic adult patients who are undergoing MRI scan as part of chronic pain management. At alternate MRI scan sessions, each patient receives rotational premedication using Lorazepam 1mg; or Clonidine tablet 0.2mg; or combined Clonidine 0.2mg + Lorazepam 1mg.
The patient will use the Claustrophobia Questionnaire (CLQ), a special validated tool, to collect data on the days before and after each MRI scan. The CLQ is a patient-administered tool that is used to record the severity and presence of claustrophobia symptoms, on a measurement range of 0 to 104. A change in the CLQ scores by 12-points is considered significant. In addition, the patient will use the General Anxiety Disorder Questionnaire (GAD-7), a special validated tool, to collect data on the days before and after each MRI scan. The GAD-7 is a patient-administered tool that is used to record the severity and presence of anxiety symptoms, on a measurement range of 0 to 21. A change in the GAD-7 scores by 3-points is considered significant.
Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Claustrophobic adult patients | – | –Claustrophobic adult patients who are undergoing MRI scan as part of chronic pain management. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult claustrophobic patients who are undergoing MRI scan as part of chronic pain management. Previous incomplete MRI because of claustrophobia.
Key inclusion criteria (8 listed)
- diagnosed with claustrophobia
- previous incomplete MRI because of claustrophobia
- adult patients
- good treatment compliance
- reliable Claustrophobia Questionnaire (CLQ) diary
Key exclusion criteria (9 listed)
- poor treatment compliance
- cognitive disorder
- inability to provide consent
- major neuropsychiatric disorder
- unreliable diary
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
Rate of completion of MRI scan
Time frame: 12 weeks
Patient is calm and cooperative, completes MRI scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Related trials for Claustrophobia
Not yet recruiting
Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients
Head and Neck Cancer, Claustrophobia
Not yet recruitingPhase 2/3
Evaluation of the Effectiveness of a Cardiac Coherence Exercise on MRI Success and Image Quality in Claustrophobic Patients
Claustrophobia, MRI
Recruiting
Internet-Based Cognitive Behavioral Therapy for MRI-Related Anxiety
Anxiety, Claustrophobia
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.
Olu Bamgbade, MD,FRCPC principal investigator
Salem Anaesthesia Pain Clinic
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 Claustrophobia, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olu Bamgbade, MD,FRCPC (17786286600, salem.painclinic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of completion of MRI scan (time frame: 12 weeks). 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 27 Jan 2025.