Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00734721

Acronym

FIVA

Enrollment

Registered

2008-08-14

Start date

2007-12-01

Completion date

2012-06-01

Last updated

2017-12-26

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

Conditions

Age-related Macular Degeneration, Stress

Keywords

intravitreal injection

Brief summary

1. Intravitreal injection can induce perioperative stress for the patients. 2. Different factors can modulate the pre-operative fear and physiologic reaction.

Detailed description

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

Interventions

BEHAVIORALPreoperative information and perioperative care

Patients receive different information and care in addition to the basic medical consultation.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

OTHER

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* First intravitreal injection received ever

Exclusion criteria

* No known affective or mental disorder * Condition does not allow standardized survey

Design outcomes

Primary

Measure	Time frame
Objective parameters of stress reaction	12 months

Secondary

Measure	Time frame
Subjective Response (state-trate anxiety) in respect of coping behaviour	12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026