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

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Age-related Macular Degeneration; Stress

Treatments: Behavioral: Preoperative information and perioperative care

Study type: Interventional

Funder types: Other

Identifiers

NCT00734721

UEH-2007FIV

Details and patient eligibility

About

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

Full description

The aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First intravitreal injection received ever

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

A

Active Comparator group

Description:

Presentation of factual information video

Treatment:

Behavioral: Preoperative information and perioperative care

B

Active Comparator group

Description:

Presentation of injection syringe/needle

Treatment:

Behavioral: Preoperative information and perioperative care

C

Active Comparator group

Description:

Presentation of emotional information video

Treatment:

Behavioral: Preoperative information and perioperative care

D

Active Comparator group

Description:

Stress relaxation music

Treatment:

Behavioral: Preoperative information and perioperative care