Premedication for Claustrophobic Patients for MRI Scan

Sponsor

Salem Anaesthesia Pain Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05876117

Collaborator

(none)

Enrollment

Location

41.9

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Claustrophobia

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

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Clonidine and Lorazepam Premedication for Claustrophobic Patients During MRI Scan

Actual Study Start Date :

Jul 4, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Claustrophobic adult patients Claustrophobic adult patients who are undergoing MRI scan as part of chronic pain management.

Outcome Measures

Primary Outcome Measures

Rate of completion of MRI scan [12 weeks]
Patient is calm and cooperative, completes MRI scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

poor treatment compliance
cognitive disorder
inability to provide consent
major neuropsychiatric disorder
unreliable diary
cannabis use
excessive alcohol intake
previous adverse/allergic reactions to clonidine
previous adverse/allergic reactions to lorazepam

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salem Anaesthesia Pain Clinic	Surrey	British Columbia	Canada	V3S 7J1

Sponsors and Collaborators

Salem Anaesthesia Pain Clinic

Investigators

Principal Investigator: Olu Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Salem Anaesthesia Pain Clinic

ClinicalTrials.gov Identifier:

NCT05876117

Other Study ID Numbers:

SalemAnes2022 MRI Premedicate

First Posted:

May 25, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Salem Anaesthesia Pain Clinic

Claustrophobia MRI

Additional relevant MeSH terms:

Phobic Disorders

Study Results

No Results Posted as of May 31, 2023