The aim of the study is to understand whether enhanced oxytocin levels lead to increased eye contact between patient and physician, and if this in turn improves the patient-physician relationship as perceived by the patient.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychologische omstandigheden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Level of eye contact: The level of eye contact will be measured using eye
tracking and will be operationalized as total eye gaze time towards the eye
region of the physician in the video. While participants watch the screen,
their eye movements will be tracked using Tobii screen eye tracker. The
analysis will be done using automatized *Area Of Interest* definition, and
defined through algorithms. The time for each Area Of Interest *eye region,
forehead, mouth, other* will be calculated. Total duration (time in seconds and
number of subsequent fixations) of participant*s eye gaze during a visit within
the area of interest (eye region of physician) will be taken into account in
the statistical test.
Participants* perception of the relationship with the physician: Measured with
an adjusted version of the Wake Forest Physician Trust Scale (the adjustments
entail omitting two items and a slight change of the wording of other items, as
our proposed communication process is not a real life situation). This
questionnaire is used to provide insight in a patients* trust in their
physician and consists of 10 items, answered on a 5-point Likert scale.
Secondary outcome
Satisfaction with the physician: as measured with a visual analogue scale (VAS)
ranging from 0 (not likely at all) to 100 (most likely) asking *I would
recommend this doctor to a friend or family member.*
Pupillometry: The measurement of pupil size and reactivity (dilation and
restriction), measured with the Tobii screen eye tracker.
Satisfaction with the doctors* communication style: Measured with the Doctor
Communication Style items (translated to Dutch with forward-backward
translation) on two subscales: affiliativeness and dominance/activity. Items
are answered on a 5-point Likert Scale from *strongly agree* to *strongly
disagree*.
Recall and Recognition (of information as explained during the medical
communication video): questionnaire which assesses participants* level of free
recall and recognition of information provided by the videotaped physician. The
questionnaire will be designed based on the information provided in the video.
Background summary
To ensure optimal quality of care, the relationship between patient and
physician is crucial. Eye contact is crucial for interpersonal communication
and has been shown to contribute to the patient-physician relation. Oxytocin
plays a central role in the creation of relationships and bonding between
people and may hence play a role in the patient-physician relationship. The
administration of oxytocin has been used to enhance the amount of eye contact
between individuals.
Study objective
The aim of the study is to understand whether enhanced oxytocin levels lead to
increased eye contact between patient and physician, and if this in turn
improves the patient-physician relationship as perceived by the patient.
Study design
A randomized double blind placebo controlled crossover trial will be conducted.
Participants act as analogue patients, in other words: they will be instructed
to interact with a physician in a video while imagining themselves as the
patient. They will receive placebo and 24 IU intranasally administered oxytocin
in a randomized and counterbalanced order. Both researchers and participants
will be blind to this order. Their gazing behaviour during the video will be
assessed using eye tracking. In between the two sessions there will be a
wash-out time of ideally seven days (at least four days and a maximum of nine
days).
Intervention
1 time 24 IU internasal oxytocin and 1 time placebo solution.
Study burden and risks
Oxytocin is a safe drug: the risk classification associated with this study is
*minimal excess of negligible risk*. We therefore estimate both the physical
and the psychological burden to be negligible.
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
Healthy, male subjects aged 18 to 35 years Subjects must be in good general
healthRefrain from alcohol/smoking/caffeine/drugs 24 hrs before the experiment
Refrained from food/drinks (except water) and intensive exercise two hours
before the administration of oxytocinPrevious experience with healthcare
system, in order to ensure that the subject is able to put himself in the role
of a patient Subjects must be able to communicate well with the investigator in
Dutch, to understand and comply with the requirements of the study, and
understand and sign the written informed consentnclusiecriteri
Exclusion criteria
Known hypersensitivity to oxytocin or to any of the excipients of oxytocin or
placeboParticipants who did not abstain from alcohol/smoking/caffeine/drugs 24
hrs before the experiment Participants who did not abstain from food/drinks
(except water) and intensive exercise two hours before the administration of
oxytocinParticipants who did not meet the above specified inclusion criteria
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004081-34-NL |
| CCMO | NL69901.018.19 |