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
Recruitment status was Recruiting
Sponsor:
University Hospital Tuebingen
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
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Purpose
- Intravitreal injection can induce perioperative stress for the patients.
- 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: Double Blind (Caregiver, 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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
Further study details as provided by University Hospital Tuebingen:
Primary Outcome Measures:
- Objective parameters of stress reaction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Subjective Response (state-trate anxiety) in respect of coping behaviour [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Ziemssen/Dr, University Eye Hospital Tuebingen |
| ClinicalTrials.gov Identifier: | NCT00734721 History of Changes |
| Other Study ID Numbers: | UEH-2007FIV |
| Study First Received: | August 13, 2008 |
| Last Updated: | August 13, 2008 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Tuebingen:
|
intravitreal injection |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013