Effect of emotional context on the placebo response in a nausea-inducing model

Not Applicable

• Conditions: auseaHealthy volunteers

• Registration Number: DRKS00027033
• Lead Sponsor: Institut für Medizinische Psychologie, LMU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-11-04
• Study Start: 2022-12-08
• Results First Posted: 2023-06-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

Healthy female subjects
-Age between 18 and 65 years
-Written informed consent

Exclusion Criteria

-Age <18 years or > 50 years
-Body mass index < 18 or > 30
-Pregnancy or breast feeding
-Implanted devices (e.g., pacemaker, insulin pump) or metal implants
-Inability to imply with the specific instructions
-Alcohol or drug abuse
-History of diseases of the inner ear (e.g., M. Menière, acute hearing loss),
-History of blood-clotting disorders or tendency to thromboembolic diseases
-History of neurological or psychiatric disease
-Any chronic somatic or psychiatric disease, especially skin diseases, diabetes, cardiovascular disease, epilepsy, cancer
-Regular intake of any medication except for hormonal contraceptives, thyroid medications, allergy medications

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress-induced modulation of placebo effect on nausea (11-point Numerical Rating Scale; NRS) in the target period (2nd half of nausea stimulation); interaction stress (yes/no) x treatment (placebo/no treatment).

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes: Stress-induced modulation of the placebo effect on symptoms of motion sickness in the target period, assessed by the Motion sickness severity questionnaire (MSSQ); Stress-induced modulation of the placebo effect on symptoms of motion sickness in the target period, assessed by the normo-to-tachy ratio in the electrogastrogram. <br><br>Other outcomes: Salivary cortisol, heart rate, respiratory rate, mood (NRS), inner tension (NRS), state anxiety (STAI), time estimation (VAS).