Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections - Full Text View

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00734721

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors

Resource links provided by NLM:

Genetics Home Reference related topics: 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
A: Active Comparator Presentation of factual information video	Behavioral: Preoperative information and perioperative care Patients receive different information and care in addition to the basic medical consultation.
B: Active Comparator Presentation of injection syringe/needle	Behavioral: Preoperative information and perioperative care Patients receive different information and care in addition to the basic medical consultation.
C: Active Comparator Presentation of emotional information video	Behavioral: Preoperative information and perioperative care Patients receive different information and care in addition to the basic medical consultation.
D: Active Comparator 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, BW
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:	University Eye Hospital Tuebingen ( Ziemssen/Dr )
Study ID Numbers:	UEH-2007FIV
Study First Received:	August 13, 2008
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00734721 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:

intravitreal injection

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Stress
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on September 04, 2009