Skip to content

The TEMP II Study: the central and peripheral body temperature response after social stress: a follow up study

The TEMP II Study: the central and peripheral body temperature response after social stress: a follow up study - The TEMP II Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34706
Enrollment
24
Registered
2010-05-26
Start date
2010-10-23
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

On each testing day (total: two testing days, day1 : TSST
day 2: placebo stress test) 1 Telemetry pill All participants receive and ingest a telemetry pill and attach a skin patch (Vitalsense Minimitter, size 2.3 x 0.87 cm) on the day of the TSST, at leas

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

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

MeasureTime frame
The primary outcome measure is the body temperature reaction in response to the TSST.

Secondary

MeasureTime frame
The Secondary outcome measures are: - heart rate responses after the TSST - saliva cortisol levels in response to the TSST - various stress questionnaire outcomes before and after the TSST - correlation of temperature responses with heart rate, cortisol and stress questionnaires

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)