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

December 22, 2017 updated by: University Hospital Tuebingen

Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tuebingen, BW, Germany, 72076
        • University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First intravitreal injection received ever

Exclusion Criteria:

  • No known affective or mental disorder
  • Condition does not allow standardized survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective parameters of stress reaction
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective Response (state-trate anxiety) in respect of coping behaviour
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEH-2007FIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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