The primary objective of the study is to determine whether inhalation of orange odor leads to a reduced stress response as evidenced by blunted cortisol response and a reduction of self-reported stress and anxiety compared to inhalation of room air…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
stress en angst, niet in een klinische context, dus normale stressvorming bij gezonde personen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are salivary cortisol (psychophysiological) as direct
measure of social, autonomic stress, and self-reported stress and anxiety.
Secondary outcome
The secundary endpoints are skin conductance response and heart rate as
measures of autonomic stress, and mood.
Background summary
Orange odor has been used in public places to reduce stress or anxiety. This
application seems to be based on two published quasi-experimental studies with
humans, that we have been unable to replicate. We here propose a laboratory
experiment aimed at investigating the effect of exposure to orange odor on
psychophysiological measures of stress and subjective self-report.
Study objective
The primary objective of the study is to determine whether inhalation of orange
odor leads to a reduced stress response as evidenced by blunted cortisol
response and a reduction of self-reported stress and anxiety compared to
inhalation of room air. The secondary objective is to determine effects of
orange odor exposure on skin conductance response and heart rate, as well as
mood. The objective of the study is not to determine whether the purported
effects are pharmacological or psychological.
Study design
The proposed study is a single-blind randomized placebo-controlled trial. It is
emphasized that this study is not a clinical drug trial, because the
intervention concerns a commercially available essential oil, not an
investigational medicinal product.
Intervention
In order to induce stress, the Trier Social Stress Test will be administered:
Participants will be asked to give an oral presentation to an expert panel of
judges, followed by a sequential arithmetic task. There will be two conditions
in a between-subjects design. Participants will be exposed to the odor of the
essential odor of orange or to room air.
Study burden and risks
The TSST is an effective stress induction paradigm that has been widely used.
Although stressful, the levels of stress are considered mild to moderate and
bearable for most people. The burden on the participant is therefore relatively
small. Participants will be allowed to relax after the task. There are no known
risks from exposure to the essential oil of orange. The potential benefits are
that if orange oil shows to be effective, it can be easily applied without much
effort or risk to reduce social stress.
Heidelberglaan 1
3508 TC Utrecht
Nederland
Heidelberglaan 1
3508 TC Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Students who are generally healthy, between 18-25 years of age, do not have a psychiatric condition specifically an anxiety disorder or post-traumatic stress disorder, who are not pregnant or possibly pregnant, who have a good (self-reported) sense of smell, no severe allergies, no asthma, will be included in the study. Participants will not be on any prescribed medications other than oral contraceptives. Participants who have a severe cold or the flu at the time of the lab visit will be rescheduled.
Exclusion criteria
Students who indicate not to be healthy in general, are below 18 years or above 25, to have a psychiatric condition, or, specifically an anxiety disorder or post-traumatic stress disorder, low-average sense of smell, to be pregnant or possibly pregnant, to have severe allergies or asthma will be excluded from the study. Orange odor may have anxiolytic or sedative effects. Participants who are on prescribed medications will be excluded from the study. We will not check whether these are anxiolytics or sedatives in order not to invade the participant*s privacy too much (advice of M.D. involved in study, Dr. Klopping-Ketelaars).
There is no specific reason for excluding pregnant women in the sense that this procedure is potentially harmful for pregnant women (or the unborn foetus), but we think it is undesirable to expose pregnant women to undue stressors.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30527.041.10 |