The aim of the proposed research is to test the hypothesis that the potential role of disgust propensity and/or sensitivity in a group of patients with vaginismus is enhanced compared to dyspareunia and healthy control subjects. This fMRI study,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Sexual dysfunction
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are signal change in bold responses to emotion, in
relation to the presented pictures on the four domains (i.e. fear; disgust;
coitus and neutral), to the groups (healthy, dysparuenia, vaginismus), and to
stimulus domain x group interaction.
Secondary outcome
Behavioural and physiological differences between groups and their relation to
the measured BOLD response.
Background summary
In this project, we will look closely at two distinct areas of interest;
disgust and sexual dysfunction (SD), together with the interaction between
them. Despite the intuitive connection, this did not necessarily reflect itself
in literature. Nevertheless, human sexuality is currently on the forefront of
women*s health issues, as SD may have a serious negative impact on
relationships and overall emotional well-being across different life stages. If
left untreated, SD could cause silent suffering and raw emotional pain. Our
principal emotion of interest, disgust, is also a recently growing formulation
in its own right after being labeled as the *forgotten emotion of
psychiatry* .
Study objective
The aim of the proposed research is to test the hypothesis that the potential
role of disgust propensity and/or sensitivity in a group of patients with
vaginismus is enhanced compared to dyspareunia and healthy control subjects.
This fMRI study, together with rather comprehensive behavioural and
physiological measures will be used to investigate implicit and explicit
responses. This will direct us, to better locate areas of disgust in the brain.
We anticipate that in this study automatic associations (AA) of sexual-disgust
could be more accessible providing more information on
disgust-induced-defensive-behaviour (DIDB). Utilizing fMRI techniques, the
proposed study aims to evaluate the key patterns of brain activation, therefore
the neural substrate associated with sexual, fearful, neutral and disgusting
stimuli in female subjects with vaginismus, dyspareunia and in a healthy
control group.
Study design
In this study a total of 60 subjects will participate, 20 subjects per group.
Subjects will be asked to fill in ten questionnaires and a subjective picture
rating post fMRI experiment. Whilst lying in the fMRI scanner subjects will be
presented with a number of pictures (in a block design) and will have
psycho-physiological measures and a visual analogue scale to rate pictures
between the blocks of stimuli presented.
Study burden and risks
Subjects will be exposed to a magnetic field of 3 Tesla and rapidly alternating
magnet gradients and radio frequency fields. This field strength is used on a
routinely basis in fMRI and MRI research. So far, no side effects have been
described. On rare occasions, a peripheral nerve (abdomen) is stimulated by the
changing magnet gradients. This will cause an itching feeling, but it is not
harmful. Therefore, the participating subjects will have minimal to negligible
burden due to the nature of the study itself (e.g. staying in the scanner for
half an hour). However, subjects will be given comprehensive information about
the study, prior signing the informed consent and full freedom to withdraw from
the study at any point and for any reason, if they wish to do so. Subjects will
be screened whether they are fMRI safe twice; therefore, risks are further
minimized. Moreover, they will be offered the option to contact the independent
physician for further questions or concerns that they might have generated
throughout the study.
The study population shall be composed of two clinical groups, in addition to a
control (healthy) group. This study cannot be conducted with a diverse
population sample. Our planned research is relevant in the fields of clinical
psychopathology and experimental psychotherapy. This study aims at filling in
theoretical gaps in the arena of SD and disgust and how these are represented
in the brain. To our knowledge, this is the first study of its kind, and it
should offer hands-on applications of the findings in a variety of areas. The
findings of this study will aim to aid in the refinement of the current
available treatment for females inflicted with vaginismus.
dept of clinical and development psychology, grote kruisstraat 1/2 9712TS
9712TS
Nederland
dept of clinical and development psychology, grote kruisstraat 1/2 9712TS
9712TS
Nederland
Listed location countries
Age
Inclusion criteria
FMRI safe
Over 18 years of age
Females
Exclusion criteria
drug abuse
pregnancy
non fMRI safe
Please for a detailed list of the inclusion and exclusion criteria see protocol section c of the dossier
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 | NL27361.042.09 |