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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 25, 2017
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Stress Behavioral: Preoperative information and perioperative care Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors
Actual Study Start Date : December 1, 2007
Primary Completion Date : May 1, 2010
Study Completion Date : June 1, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

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

Eligibility Criteria

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


Locations
Germany
University Eye Hospital
Tuebingen, BW, Germany, 72076
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 Posted: August 14, 2008    Key Record Dates
Last Update Posted: December 25, 2017
Last Verified: August 2008

Keywords provided by University Hospital Tuebingen:
intravitreal injection

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