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
  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: 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:


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 April 17, 2014