A pill against fear and phobia? The effects of propranolol on memories of individuals suffering from dental phobia. A prospective double blind randomized controlled trial.

A pill against fear and phobia? The effects of propranolol on memories of individuals suffering from dental phobia. A prospective double blind randomized controlled trial. - A pill against fear and phobia?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34861

Enrollment

Registered

2011-01-04

Start date

2010-04-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anxiety

Interventions

After a standardized period of 14 days after initial assessment all patients we be re-assessed using the same self-report measures as administered at the initial assessment. Patients return for rout

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients will be admitted to the study if they present with a formal diagnosis of specific phobia (i.e., dental phobia), are over 18 years, and are willing to give informed consent.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they present with (a) a systolic blood pressure (SBP)

Design outcomes

Primary

Measure	Time frame
- The primary outcome measure used in this trial is the Short version of the Dental Anxiety Inventory (S-DAI; Aartman, 1998). The S-DAI is a nine-item scale measuring dental anxiety. Responses are scored 15, giving total scores ranging from 9 (not anxious at all) to 45 (extremely anxious). - VAS-scales that assess various aspects of the memories. For example, patients will be asked to rate the extent to which various emotions (e.g., sad, guilty, ashamed, anxious, angry, helpless) accompanied their memories, on a scale from 0 (not at all) to 100 (very much so). In addition, patients will be asked to rate the vividness of two key-memories, their sense of nowness* and re-experiencing of physical sensations and emotions that were present in the original event, impact in terms of interference with daily activities, uncontrollability, and distress caused by the intrusion over the past week.	—

Measure

Time frame

- The primary outcome measure used in this trial is the Short version of the Dental Anxiety Inventory (S-DAI; Aartman, 1998). The S-DAI is a nine-item scale measuring dental anxiety. Responses are scored 1*5, giving total scores ranging from 9 (not anxious at all) to 45 (extremely anxious). - VAS-scales that assess various aspects of the memories. For example, patients will be asked to rate the extent to which various emotions (e.g., sad, guilty, ashamed, anxious, angry, helpless) accompanied their memories, on a scale from 0 (not at all) to 100 (very much so). In addition, patients will be asked to rate the vividness of two key-memories, their sense of *nowness* and re-experiencing of physical sensations and emotions that were present in the original event, impact in terms of interference with daily activities, uncontrollability, and distress caused by the intrusion over the past week.

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Secondary

Measure	Time frame
- To be able to accurately measure PTSD symptom severity on a continuous scale the Dutch version of the Impact of Event Scale-Revised (IES-R; Weiss & Marmar, 1997) will be used. This scale consists of 22 items constituting the subscales intrusions, avoidance and hyper arousal. When scoring the IES-R, subjects are asked to indicate how frequently the symptoms had been present during the past seven days. The frequency of each symptom is scored using a 5-point (04) response format with equal intervals, ranging from not at all* (0) to very much (5). The scores can be summed to produce a total IES-R score (range 0* 110) with a higher score indicating a greater level of post-traumatic stress phenomena. - The Korte Klachten Lijst (KKL; Lange, Schrieken, van de Ven & Blankers, 2000) will be used to assess level of psychopathological symptoms. The KKL consists of 14 items with a 4-point scale and is a short version of the SCL-R-90 measuring the same dimensions (Arrindell & Ettema, 1986). For the present study, the total score is used. This is the sum of the items, and can vary between 0 and 56. .	—

Measure

Time frame

- To be able to accurately measure PTSD symptom severity on a continuous scale the Dutch version of the Impact of Event Scale-Revised (IES-R; Weiss & Marmar, 1997) will be used. This scale consists of 22 items constituting the subscales intrusions, avoidance and hyper arousal. When scoring the IES-R, subjects are asked to indicate how frequently the symptoms had been present during the past seven days. The frequency of each symptom is scored using a 5-point (0*4) response format with equal intervals, ranging from *not at all* (0) to *very much* (5). The scores can be summed to produce a total IES-R score (range 0* 110) with a higher score indicating a greater level of post-traumatic stress phenomena. - The Korte Klachten Lijst (KKL; Lange, Schrieken, van de Ven & Blankers, 2000) will be used to assess level of psychopathological symptoms. The KKL consists of 14 items with a 4-point scale and is a short version of the SCL-R-90 measuring the same dimensions (Arrindell & Ettema, 1986). For the present study, the total score is used. This is the sum of the items, and can vary between 0 and 56. .

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)