Contagious Itch, Disgust and Empathy in Patients and Medical Staff
Primary Purpose
Contagious Itch
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
7-items-questionnaires addressing CI, disgust and empathy
Saarbrucken Personality questionnaire (SPQ) addressing empathy.
10-items-questionnaire addressing previous dermatological conditions, intensity of itch
ItchyQol-questionnaire composed of 22 items addressing itch-related symptoms, functions and emotions
Sponsored by
About this trial
This is an interventional diagnostic trial for Contagious Itch focused on measuring itch, scabies, ectoparasites, post-scabetic itch, disgust, empathy
Eligibility Criteria
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:
-
Sites / Locations
- Department of Dermatology; University Hospital Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
medical staff treating patients with scabies
family infested with scabies
Arm Description
Outcomes
Primary Outcome Measures
Intensity of emotion (CI, disgust and empathy) in medical staff treating patients with scabies
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).
Intensity of emotion (CI, disgust and empathy) in family infested with scabies
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).
Empathy scored by Saarbrucken Personality Questionnaire (SPQ)
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT04557644
First Posted
September 15, 2020
Last Updated
November 3, 2021
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT04557644
Brief Title
Contagious Itch, Disgust and Empathy in Patients and Medical Staff
Official Title
Contagious Itch, Disgust and Empathy in Patients and Medical Staff
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contagious Itch
Keywords
itch, scabies, ectoparasites, post-scabetic itch, disgust, empathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study both the staff and the infested family are to complete questionnaires addressing CI, disgust and empathy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medical staff treating patients with scabies
Arm Type
Active Comparator
Arm Title
family infested with scabies
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
7-items-questionnaires addressing CI, disgust and empathy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saarbrucken Personality questionnaire (SPQ) addressing empathy.
Intervention Description
Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool.
Intervention Type
Other
Intervention Name(s)
10-items-questionnaire addressing previous dermatological conditions, intensity of itch
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
ItchyQol-questionnaire composed of 22 items addressing itch-related symptoms, functions and emotions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of emotion (CI, disgust and empathy) in medical staff treating patients with scabies
Description
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).
Time Frame
one point assessment at baseline
Title
Intensity of emotion (CI, disgust and empathy) in family infested with scabies
Description
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).
Time Frame
one point assessment at baseline (first day of hospitalisation)
Title
Empathy scored by Saarbrucken Personality Questionnaire (SPQ)
Description
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".
Time Frame
one point assessment at baseline (first day of hospitalisation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Mueller, PD Dr. med.
Organizational Affiliation
Department of Dermatology, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology; University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
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Contagious Itch, Disgust and Empathy in Patients and Medical Staff
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