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LI(chten)Fe(ls) trial on the intensity of the nocebo effect concerning potential adverse effects after covid-19 vaccination based on the elaborateness of the medical briefing

LI(chten)Fe(ls) trial on the intensity of the nocebo effect concerning potential adverse effects after covid-19 vaccination based on the elaborateness of the medical briefing - LIFe trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00026091
Enrollment
1500
Registered
2022-05-10
Start date
2021-07-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The trial hypothesis says that a concise medical briefing before SARS-CoV-2 vaccination can reduce the occurence and intensity of vaccination associated adverse effects.

Interventions

Group 1: The medical briefing of the control group will be very in-depth. The doctor will precisely adhere to the leaflet („detailed medical briefing“) that had been handed out beforehand with all pos

Sponsors

Impfzentrum Lichtenfels
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Only patients that were willing and able to give consent are included in this study.

Exclusion criteria

Exclusion criteria: Patients that were not willing or unable to give consent were not included in this study.

Design outcomes

Primary

MeasureTime frame
General occurrence of adverse effects, that can be attributed to the vaccination. Specification of the adverse effects that possibly occurred and their intensity. Use of painkillers to reduce the adverse effects and, if yes, specification of the painkiller. Requirement of a doctoral sick note after the vaccination and, if yes, duration of sick leave. These points are queried using an online or offline questionnaire 5 days after the vaccination (multiple choice).

Secondary

MeasureTime frame
Rating of the visit at the Lichtenfels Vaccination Center. Satisfaction with the medical briefing.

Countries

Germany

Contacts

Public ContactNora Beller

Landratsamt Lichtenfels

norabeller+LIFe@gmail.com+49 9571180

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026