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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32739

Enrollment

Registered

2008-11-04

Start date

2009-05-08

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

normale fysiologische stressrespons physiological autonomic stress reactivity

Interventions

1 Telemetry pill All participants receive and ingest a telemetry pill (Vitalsense Minimitter, size 2.3 x 0.87 cm) on the day of the TSST, at least 1 hour before commencing the TSST. Immediately aft

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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))

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the body temperature reaction in response to the TSST.	—

Secondary

Measure	Time frame
The Secondary outcome measures are: - blood pressure and heart rate responses after the TSST - saliva cortisol levels in response to the TSST - various stress questionnaire outcomes before and after the TSST	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)