Effects of negative expectation on visceroception and visceral pain

Effects of negative expectation on visceroception and visceral pain - NoVis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024410

Enrollment

120

Registered

2021-03-22

Start date

2021-06-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

healthy male and female volunteers

Interventions

Group 1: All study groups will receive experimental visceral and somatic pain stimuli on 2 experimental days. Arm 1: negative instruction and negative learning experience Group 2: All study groups w

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Fluent in German, BMI 18-30

Exclusion criteria

Exclusion criteria: Acute and chronic health conditions, especially chronic pain, gastrointestinal conditions, mental disorders, cardiovascular conditions. Regular medication intake. Any evidence suggesting psychiatric conditions based on self-report and during screening with validated instruments. MRI-specific exclusion criteria (metal implants, claustrophobia, etc.); any evidence of anorectal changes upon screening and physical examination that would interfere with rectal distensions. In women: pregancy, breastfeeding, oral hormonal contraceptives

Design outcomes

Primary

Measure	Time frame
Pain perception (intensity, unpleasantness) assessed with visual analogue scales, pain-related fear and avoidance, treatment expectations and expected side effects (validated questionaires: GASE; GEEE)	—

Secondary

Measure	Time frame
Repeated assessements of psychologial parameters before and after each pain stimulation series: State anxiety (STADI), pain- and stress-relevant neuroendocrine and immune markers, especially cortisol and alpha-amylase, in saliva and blood; psychophysiological responses (skin conductance, heart rate) to pain-predictive cues and pain stimuli. Measures assessing aspects of the doctor-patient relashionship and pain-related memory aspects with rating skales. Psychological traits assessed prior to the study (questionnaire battery assessing personality, pain, coping, etc). Resting state fMRI and DTI, cortisol awakening response prior to the study as part of the central CRC projects; microbiome in stool samples.	—

Measure

Time frame

Repeated assessements of psychologial parameters before and after each pain stimulation series: State anxiety (STADI), pain- and stress-relevant neuroendocrine and immune markers, especially cortisol and alpha-amylase, in saliva and blood; psychophysiological responses (skin conductance, heart rate) to pain-predictive cues and pain stimuli. Measures assessing aspects of the doctor-patient relashionship and pain-related memory aspects with rating skales. Psychological traits assessed prior to the study (questionnaire battery assessing personality, pain, coping, etc). Resting state fMRI and DTI, cortisol awakening response prior to the study as part of the central CRC projects; microbiome in stool samples.

—

Countries

Germany

Contacts

Public ContactSigrid Elsenbruch

Universitätsklinikum Essen, Klinik für Neurologie, Translational Pain Research Unit

sigrid.elsenbruch@uk-essen.de0201 723 2446

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026