Effects of negative mood and systemic low-grade inflammation on visceral pain perception and visceral pain processing

Not Applicable

• Conditions: Healthy volunteers; R10.4; Other and unspecified abdominal pain

• Registration Number: DRKS00016994
• Lead Sponsor: niversitätsklinikum Essen, Institut für Medizinische Psychologie und Verhaltensimmunbiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Study Completion: 2021-02-17
• Results First Posted: 2023-06-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Healthy male and female (using contraceptives) volunteers, aged 18-50, right-handed

Exclusion Criteria

Acute and chronic conditions, intake of medication (excluding oral contraceptives). Smoking, body mass index > 30 oder < 18 kg/m². Anorectal tissue damage and evidence of structural brain abnormality upon structural MRI scan. Additional MRI-specific exclusion criteria included phobic anxiety, claustrophobia and ferromagnetic implantations. Psychiatric conditions (anxtiety, depression) based on DSM-V criteria, assessed with validated screening instruments.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of sensory-discriminative, affective, and cognitive components of pain, as well as of psychological states (mood) using visual analogue scales (VAS). Assessment of neural (blood-oxygen level-dependent, BOLD) responses to visceral stimuli and to mood-related cues using fMRI. Outcome variables will be assessed 2-4h post-injection of LPS (lipopolysaccharide) or placebo, respectively. <br><br>

Secondary Outcome Measures

Name	Time	Method
Repeated measures (baseline, as well as 1h, 2h, 3h, 4h, 6h und 24h after injection of LPS/placebo): Plasma TNF-a, IL-6, IL-10, cortisol. Blood pressure, heart rate, body temperature. Psychological states (mood, anxiety) and bodily symptoms using validated questionnaires (MDBF; STADI; STAI-S; GASE). <br><br>Before the first study day, a questionnaire battery will be filled in to assess the health status and psychological traits (including symptoms of depression and anxiety, pain-related cognitions, coping, personality traits).