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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027033

Enrollment

Registered

2022-12-08

Start date

2015-11-04

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

Nausea Healthy volunteers

Interventions

Group 1: Verum intervention (TENS stimulation of an acupuncture point) after experimental stress induction in an experimental nausea paradigm. Group 2: Verum intervention (TENS stimulation of an acupu

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Age 50 years - Body mass index 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. Other outcomes: Salivary cortisol, heart rate, respiratory rate, mood (NRS), inner tension (NRS), state anxiety (STAI), time estimation (VAS).	—

Measure

Time frame

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. Other outcomes: Salivary cortisol, heart rate, respiratory rate, mood (NRS), inner tension (NRS), state anxiety (STAI), time estimation (VAS).

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Countries

Germany

Contacts

Public ContactKarin Meißner

Institut für Medizinische Psychologie, LMU München

karin.meissner@med.lmu.de089/218075613

Outcome results

None listed

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