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Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections (FIVA)

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ClinicalTrials.gov Identifier: NCT00734721
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : December 26, 2017
Sponsor:
Information provided by:
University Hospital Tuebingen

August 13, 2008
August 14, 2008
December 26, 2017
December 1, 2007
May 1, 2010   (Final data collection date for primary outcome measure)
Objective parameters of stress reaction [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00734721 on ClinicalTrials.gov Archive Site
Subjective Response (state-trate anxiety) in respect of coping behaviour [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections
Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors
  1. Intravitreal injection can induce perioperative stress for the patients.
  2. Different factors can modulate the pre-operative fear and physiologic reaction.
The aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
  • Age-related Macular Degeneration
  • Stress
Behavioral: Preoperative information and perioperative care
Patients receive different information and care in addition to the basic medical consultation.
  • Active Comparator: A
    Presentation of factual information video
    Intervention: Behavioral: Preoperative information and perioperative care
  • Active Comparator: B
    Presentation of injection syringe/needle
    Intervention: Behavioral: Preoperative information and perioperative care
  • Active Comparator: C
    Presentation of emotional information video
    Intervention: Behavioral: Preoperative information and perioperative care
  • Active Comparator: D
    Stress relaxation music
    Intervention: Behavioral: Preoperative information and perioperative care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
60
June 1, 2012
May 1, 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • First intravitreal injection received ever

Exclusion Criteria:

  • No known affective or mental disorder
  • Condition does not allow standardized survey
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00734721
UEH-2007FIV
No
Not Provided
Not Provided
Ziemssen/Dr, University Eye Hospital Tuebingen
University Hospital Tuebingen
Not Provided
Not Provided
University Hospital Tuebingen
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP