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OpenTrials
Completed

NCT Number: NCT00734721

Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections

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

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First intravitreal injection received ever

Exclusion criteria

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

Treatment and study plan

Preoperative information and perioperative care

Behavioral

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

Primary outcomes

  1. Objective parameters of stress reaction

    Time frame: 12 months

Secondary outcomes

  1. Subjective Response (state-trate anxiety) in respect of coping behaviour

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: FIVA

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Aug 14, 2008
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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