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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00734721
First Posted: August 14, 2008
Last Update Posted: August 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
  Purpose
  1. Intravitreal injection can induce perioperative stress for the patients.
  2. Different factors can modulate the pre-operative fear and physiologic reaction.

Condition Intervention Phase
Age-Related Macular Degeneration Stress Behavioral: Preoperative information and perioperative care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Objective parameters of stress reaction [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Subjective Response (state-trate anxiety) in respect of coping behaviour [ Time Frame: 12 months ]

Estimated Enrollment: 60
Study Start Date: December 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Presentation of factual information video
Behavioral: Preoperative information and perioperative care
Patients receive different information and care in addition to the basic medical consultation.
Active Comparator: B
Presentation of injection syringe/needle
Behavioral: Preoperative information and perioperative care
Patients receive different information and care in addition to the basic medical consultation.
Active Comparator: C
Presentation of emotional information video
Behavioral: Preoperative information and perioperative care
Patients receive different information and care in addition to the basic medical consultation.
Active Comparator: D
Stress relaxation music
Behavioral: Preoperative information and perioperative care
Patients receive different information and care in addition to the basic medical consultation.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First intravitreal injection received ever

Exclusion Criteria:

  • No known affective or mental disorder
  • Condition does not allow standardized survey
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734721


Contacts
Contact: Focke Ziemssen, MD 0049 7071 29 84761 Focke.Ziemssen@med.uni-tuebingen.de
Contact: Karl U Bartz-Schmidt, MD 0049 7071 29 84001

Locations
Germany
University Eye Hospital Recruiting
Tuebingen, BW, Germany, 72076
Contact: Focke Ziemssen, MD    0049 7071 29 84761    Focke.Ziemssen@med.uni-tuebingen.de   
Principal Investigator: Focke Ziemssen         
Sponsors and Collaborators
University Hospital Tuebingen
  More Information

Responsible Party: Ziemssen/Dr, University Eye Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00734721     History of Changes
Other Study ID Numbers: UEH-2007FIV
First Submitted: August 13, 2008
First Posted: August 14, 2008
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by University Hospital Tuebingen:
intravitreal injection

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases