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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Dermatology; University Hospital Basel

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: medical staff treating patients with scabies
Other: 7-items-questionnaires addressing CI, disgust and empathy
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.
Other: Saarbrucken Personality questionnaire (SPQ) addressing empathy.
Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool.
Active Comparator: family infested with scabies
Other: Saarbrucken Personality questionnaire (SPQ) addressing empathy.
Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool.
Other: 10-items-questionnaire addressing previous dermatological conditions, intensity of itch
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).
Other: ItchyQol-questionnaire composed of 22 items addressing itch-related symptoms, functions and emotions
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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