Contagious ItchNCT04557644
Contagious Itch, Disgust and Empathy in Patients and Medical Staff
A study testing 7-items-questionnaires addressing CI, disgust and empathy, Saarbrucken Personality questionnaire (SPQ) addressing empathy. and 10-items-questionnaire addressing previous dermatological conditions, intensity of itch in people with Contagious Itch, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contagious Itch
- What is being tested?
- 7-items-questionnaires addressing CI, disgust and empathy, Saarbrucken Personality questionnaire (SPQ) addressing empathy. and 10-items-questionnaire addressing previous dermatological conditions, intensity of itch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Sep 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology; University Hospital Basel
Basel, 4031
About this study
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.
Read the 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.
- Conditions
- Contagious Itch
- Being tested
- 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
- Keywords
- itch, scabies, ectoparasites, post-scabetic itch, disgust, empathy
- Medical subject headings
- Pruritus, Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-items-questionnaires addressing CI, disgust and empathyOther
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.
Saarbrucken Personality questionnaire (SPQ) addressing empathy.Other
Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool.
10-items-questionnaire addressing previous dermatological conditions, intensity of itchOther
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 composed of 22 items addressing itch-related symptoms, functions and emotionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| medical staff treating patients with scabies | Active comparator | Not described Receives: Other: 7-items-questionnaires addressing CI, disgust and empathy; Other: Saarbrucken Personality questionnaire (SPQ) addressing empathy. |
| family infested with scabies | Active comparator | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one point assessment at baseline
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).
Measured: one point assessment at baseline (first day of hospitalisation)
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".
Measured: one point assessment at baseline (first day of hospitalisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start16 Sep 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contagious ItchStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Mueller, PD Dr. med., Principal investigator, Department of Dermatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557644
- Sponsor's protocol ID
- sp20Mueller; 2020-01089
- Status last verified
- Nov 2021
- First submitted
- 15 Sep 2020
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contagious Itch, Disgust and Empathy in Patients and Medical Staff
- ClinicalTrials.gov ID
- NCT04557644
- Acronym / sponsor ID
- sp20Mueller; 2020-01089
- Conditions
- Contagious Itch
- Keywords
- itch, scabies, ectoparasites, post-scabetic itch, disgust, empathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study both the staff and the infested family are to complete questionnaires addressing CI, disgust and empathy
| Arm | Type | Receives |
|---|---|---|
| medical staff treating patients with scabies | Active comparator | Other: 7-items-questionnaires addressing CI, disgust and empathy, Other: Saarbrucken Personality questionnaire (SPQ) addressing empathy. |
| family infested with scabies | Active comparator | 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 |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-items-questionnaires addressing CI, disgust and empathy7-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. | Other | medical staff treating patients with scabies |
| Saarbrucken Personality questionnaire (SPQ) addressing empathy.Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool. | Other | family infested with scabies, medical staff treating patients with scabies |
| 10-items-questionnaire addressing previous dermatological conditions, intensity of itch10-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). | Other | family infested with scabies |
| ItchyQol-questionnaire composed of 22 items addressing itch-related symptoms, functions and emotionsItchyQol-questionnaire to assess the itch-related quality of life impairment. The ItchyQoL is composed of 22 items addressing itch-related symptoms, functions and emotions. | Other | family infested with scabies |
Primary outcome
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).
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).
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
Related trials for Contagious Itch
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Mueller, PD Dr. med. principal investigator
Department of Dermatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-items-questionnaires addressing CI, disgust and empathy, Saarbrucken Personality questionnaire (SPQ) addressing empathy. and 10-items-questionnaire addressing previous dermatological conditions, intensity of itch in people with Contagious Itch, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of emotion (CI, disgust and empathy) in medical staff treating patients with scabies (time frame: one point assessment at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.