- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557644
Contagious Itch, Disgust and Empathy in Patients and Medical Staff
November 3, 2021 updated by: University Hospital, Basel, Switzerland
This study is to assess the relationship between CI, disgust and empathy in medical staff treating patients with scabies, to differentiate the impact of visual and verbal stimuli contributing to CI and to assess information about CI, disgust and empathy in a family infested with scabies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: 7-items-questionnaires addressing CI, disgust and empathy
- Other: Saarbrucken Personality questionnaire (SPQ) addressing empathy.
- Other: 10-items-questionnaire addressing previous dermatological conditions, intensity of itch
- Other: ItchyQol-questionnaire composed of 22 items addressing itch-related symptoms, functions and emotions
Detailed Description
Itch is the commonest skin-related symptom, defined as a bodily sensation provoking the urge to scratch.
The induction of itch and scratching by mere (audio-) visual stimuli such as pictures of insects on skin or video clips showing individuals scratching themselves, indicates that itch can be perceived in the absence of a pruritogenic somatosensory stimulus.
This phenomenon is referred to as "contagious itch" (CI).
CI may play a special role in the content of scabies both for the affected patients as well as the treating staff: It is a very common phenomenon that family members who are not infested by scabies themselves experience itch when watching their infested relatives scratching.
The same is very frequently expressed by health care professionals being confronted with scabies patients.
Two further important factors may be involved in the context of CI: disgust and empathy.
Empathy is defined as a psychological concept that enables individuals to understand and share emotions of others.
Disgust is an emotional response of revulsion to potentially contagious and/or harmful objects or subjects.
This study is to assess the relationship between CI, disgust and empathy in medical staff treating patients with scabies, to differentiate the impact of visual and verbal stimuli contributing to CI and to assess information about CI, disgust and empathy in a family infested with scabies.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Basel, Switzerland, 4031
- Department of Dermatology; University Hospital Basel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- members of families (aged >7 years) hospitalized in the Department of Dermatology with scabies
- staff (physicians, nurses, nurse aids aged >16 years) involved in the treatment of these families
- Infestation of scabies in individual family members confirmed by two leading dermatologists of the University Hospital Basel by dermoscopy and/or skin scrapings.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: medical staff treating patients with scabies
|
7-items-questionnaire including numerical rating scales (NRS) ranging from 0 (no itch/disgust/empathy) to 10 (worst itch/disgust/most empathy imaginable) to rate itch, disgust and empathy they experience when treating the infested families.
Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool.
|
|
Active Comparator: family infested with scabies
|
Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool.
10-items-questionnaire (completed by the hospitalised family) regarding demographic information (gender, age, profession), previous dermatological conditions, intensity of itch a.) on the first day of the hospitalisation, b.) when seeing the skin lesions of the other family members c.) when talking about the scabies/itch with the other family members, d.) when seeing other family members scratching themselves, and questions regarding their intensity of disgust of the scabies and empathy for the other family members (0-10 NRS).
ItchyQol-questionnaire to assess the itch-related quality of life impairment.
The ItchyQoL is composed of 22 items addressing itch-related symptoms, functions and emotions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensity of emotion (CI, disgust and empathy) in medical staff treating patients with scabies
Time Frame: one point assessment at baseline
|
Score in 7-items-questionnaire including numerical rating scales (NRS) ranging from 0 (no itch/disgust/empathy) to 10 (worst itch/disgust/most empathy imaginable) to rate itch, disgust and empathy they experience when treating the infested families.
The questionnaire (see Appendix) contains questions regarding demographic information (gender, age, profession), previous dermatological conditions, intensity of itch a.) before interacting with the patients, b.) when listening to the patients telling about their infestation with scabies, c.) when seeing the skin lesions, d.) when seeing patients scratching themselves, and questions regarding their intensity of disgust of the scabies and empathy for the families (0-10 NRS).
|
one point assessment at baseline
|
|
Intensity of emotion (CI, disgust and empathy) in family infested with scabies
Time Frame: one point assessment at baseline (first day of hospitalisation)
|
Score in 10-items-questionnaire addressing intensity of itch a.) on the first day of their hospitalisation, b.) when seeing the skin lesions of the other family members c.) when talking about the scabies/itch with the other family members, d.) when seeing other family members scratching themselves and intensity of disgust of the scabies and intensity of empathy for the other family members (0-10 NRS).
|
one point assessment at baseline (first day of hospitalisation)
|
|
Empathy scored by Saarbrucken Personality Questionnaire (SPQ)
Time Frame: one point assessment at baseline (first day of hospitalisation)
|
The Saarbrucken personality questionnaire SPQ is the German version of the Interpersonality Reactivity Index (IRI) used for the measurement of empathy.
The tool is a self-report answered on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well".
|
one point assessment at baseline (first day of hospitalisation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2020
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
November 4, 2021
Last Update Submitted That Met QC Criteria
November 3, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- sp20Mueller; 2020-01089
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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