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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00734721
First received: August 13, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted

August 13, 2008
August 13, 2008
December 2007
December 2008   (final data collection date for primary outcome measure)
Objective parameters of stress reaction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Subjective Response (state-trate anxiety) in respect of coping behaviour [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • 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.
 
Recruiting
60
Not Provided
December 2008   (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
Both
18 Years and older
No
Contact: Focke Ziemssen, MD 0049 7071 29 84761 Focke.Ziemssen@med.uni-tuebingen.de
Contact: Karl U Bartz-Schmidt, MD 0049 7071 29 84001
Germany
 
NCT00734721
UEH-2007FIV
No
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