Age-related Macular DegenerationPhase 2FIVANCT00734721
Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections
A Phase 2 study testing Preoperative information and perioperative care in people with Age-related Macular Degeneration and Stress, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
1. Intravitreal injection can induce perioperative stress for the patients. 2. Different factors can modulate the pre-operative fear and physiologic reaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-related Macular Degeneration, Stress
- What is being tested?
- Preoperative information and perioperative care
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2007to 1 Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First intravitreal injection received ever
Who cannot join
- No known affective or mental disorder
- Condition does not allow standardized survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors
- Intravitreal injection can induce perioperative stress for the patients.
- Different factors can modulate the pre-operative fear and physiologic reaction.
Read the 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.
- Conditions
- Age-related Macular Degeneration, Stress
- Being tested
- Preoperative information and perioperative care
- Keywords
- intravitreal injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative information and perioperative careBehavioural
Patients receive different information and care in addition to the basic medical consultation.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Presentation of factual information video Receives: Behavioral: Preoperative information and perioperative care |
| B | Active comparator | Presentation of injection syringe/needle Receives: Behavioral: Preoperative information and perioperative care |
| C | Active comparator | Presentation of emotional information video Receives: Behavioral: Preoperative information and perioperative care |
| D | Active comparator | Stress relaxation music Receives: Behavioral: Preoperative information and perioperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective parameters of stress reaction
Measured: 12 months
Secondary outcomes (1)
Subjective Response (state-trate anxiety) in respect of coping behaviour
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study start1 Dec 2007
- Primary completion1 May 2010
- Study completion1 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734721
- Sponsor's protocol ID
- UEH-2007FIV
- Acronym
- FIVA
- Status last verified
- Aug 2008
- First submitted
- 13 Aug 2008
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Intravitreal Injection - Assessment of Psychological Strain and Potential Contributing Factors
- ClinicalTrials.gov ID
- NCT00734721
- Acronym / sponsor ID
- FIVA / UEH-2007FIV
- Conditions
- Age-related Macular Degeneration, Stress
- Keywords
- intravitreal injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 1 May 2010 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Intravitreal injection can induce perioperative stress for the patients.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Preoperative information and perioperative carePresentation of factual information video |
| B | Active comparator | Behavioral: Preoperative information and perioperative carePresentation of injection syringe/needle |
| C | Active comparator | Behavioral: Preoperative information and perioperative carePresentation of emotional information video |
| D | Active comparator | Behavioral: Preoperative information and perioperative careStress relaxation music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First intravitreal injection received ever
Key exclusion criteria (2 listed)
- No known affective or mental disorder
- Condition does not allow standardized survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative information and perioperative carePatients receive different information and care in addition to the basic medical consultation. | Behavioural | A, B, C, D |
Primary outcome
Objective parameters of stress reaction
Time frame: 12 months
1 secondary outcome
Subjective Response (state-trate anxiety) in respect of coping behaviour
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative information and perioperative care in people with Age-related Macular Degeneration and Stress, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective parameters of stress reaction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.