The TEMP study: The influence of social stress on the autonomic stress response in healthy volunteers

Completed

• Conditions: normale fysiologische stressrespons; physiological autonomic stress reactivity

• Registration Number: NL-OMON32739
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Adults (18 years or older) who provide written informed consent are eligible for the present study.

Exclusion Criteria

General exclusion criteria are:
- smoking
- any psychiatric disorder
- any significant medical condition including any gastrointestinal condition that would lead to a contraindication for the telemetric pill
- current or past drug use (positive urine screen on the presence of amphetamines (including MDMA), barbiturates, cannibinoids, benzodiazepines, cocaine and opiates)
- participation in current psychological or psychopharmacological research
- present use of any medication which might influence autonomic response, including benzodiazepines, psychotropics, beta blockers, ACE inhibitors and any hormonal treatment including oral anticonceptives.
- women in the follicular phase of the menstrual cycle
- lack of fluency in the Dutch language
- speech impairments;Acute exclusion criteria are:
- any acute illness
- fever
- having a severe cold
- recent physical exertion within the last 2 hours
- large meals within the last 2 hours
- caffein use on the test day
- high basal stress level (measured with a STAI state anxiety score over 50, average 34.3 in male students (Ploeg 2000))

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the body temperature reaction in response to the<br /><br>TSST.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Secondary outcome measures are:<br /><br>- blood pressure and heart rate responses after the TSST<br /><br>- saliva cortisol levels in response to the TSST<br /><br>- various stress questionnaire outcomes before and after the TSST </p><br>