Back to resultsAssessment of Psychological Strain and Perioperative Fear in Intravitreal Injections (FIVA)
Primary Purpose
Age-related Macular Degeneration, Stress
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Preoperative information and perioperative care
Sponsored by
About this trial
This is an interventional other trial for Age-related Macular Degeneration focused on measuring intravitreal injection
Eligibility Criteria
Inclusion Criteria:
- First intravitreal injection received ever
Exclusion Criteria:
- No known affective or mental disorder
- Condition does not allow standardized survey
Sites / Locations
- University Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
A
B
C
D
Arm Description
Presentation of factual information video
Presentation of injection syringe/needle
Presentation of emotional information video
Stress relaxation music
Outcomes
Primary Outcome Measures
Objective parameters of stress reaction
Secondary Outcome Measures
Subjective Response (state-trate anxiety) in respect of coping behaviour
Full Information
NCT ID
NCT00734721
First Posted
August 13, 2008
Last Updated
December 22, 2017
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00734721
Brief Title
Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections
Acronym
FIVA
Official Title
Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 1, 2007 (Actual)
Primary Completion Date
May 1, 2010 (Actual)
Study Completion Date
June 1, 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intravitreal injection can induce perioperative stress for the patients.
Different factors can modulate the pre-operative fear and physiologic reaction.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Stress
Keywords
intravitreal injection
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Presentation of factual information video
Arm Title
B
Arm Type
Active Comparator
Arm Description
Presentation of injection syringe/needle
Arm Title
C
Arm Type
Active Comparator
Arm Description
Presentation of emotional information video
Arm Title
D
Arm Type
Active Comparator
Arm Description
Stress relaxation music
Intervention Type
Behavioral
Intervention Name(s)
Preoperative information and perioperative care
Intervention Description
Patients receive different information and care in addition to the basic medical consultation.
Primary Outcome Measure Information:
Title
Objective parameters of stress reaction
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Subjective Response (state-trate anxiety) in respect of coping behaviour
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First intravitreal injection received ever
Exclusion Criteria:
No known affective or mental disorder
Condition does not allow standardized survey
Facility Information:
Facility Name
University Eye Hospital
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections
We'll reach out to this number within 24 hrs