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NCT00734721 Clinical Trial

Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections

Stress Clinical Trial

— FIVA  

Official title:
Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00734721
Other study ID # UEH-2007FIV
Secondary ID
Status Completed
Phase Phase 2
First received August 13, 2008
Last updated December 22, 2017
Start date December 1, 2007
Est. completion date June 1, 2012

Study information
Verified date August 2008
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Intravitreal injection can induce perioperative stress for the patients.

2. Different factors can modulate the pre-operative fear and physiologic reaction.

Description:

The aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 1, 2012
Est. primary completion date May 1, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- First intravitreal injection received ever

Exclusion Criteria:

- No known affective or mental disorder

- Condition does not allow standardized survey

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Preoperative information and perioperative care
Patients receive different information and care in addition to the basic medical consultation.

Locations
Country Name City State
Germany University Eye Hospital Tuebingen BW

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective parameters of stress reaction 12 months
Secondary Subjective Response (state-trate anxiety) in respect of coping behaviour 12 months
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