Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections

Phase 2

Completed

• Conditions: Age-related Macular Degeneration; Stress
• Interventions: Behavioral: Preoperative information and perioperative care

• Registration Number: NCT00734721
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

1. Intravitreal injection can induce perioperative stress for the patients.

2. 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.

Study Timeline

• Study Start: 2007-12-01
• Status Verified: 2008-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2010-05-01
• Study Completion: 2012-06-01
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• First intravitreal injection received ever

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A	Preoperative information and perioperative care	Presentation of factual information video
C	Preoperative information and perioperative care	Presentation of emotional information video
B	Preoperative information and perioperative care	Presentation of injection syringe/needle
D	Preoperative information and perioperative care	Stress relaxation music

Primary Outcome Measures

Name	Time	Method
Objective parameters of stress reaction	12 months

Secondary Outcome Measures

Name	Time	Method
Subjective Response (state-trate anxiety) in respect of coping behaviour	12 months

Trial Locations

Locations (1)

University Eye Hospital; 🇩🇪 Tuebingen, BW, Germany