Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals

June 19, 2024 updated by: Silvia Lo Vecchio, Aalborg University

Investigation of the Neurophysiological and Psychological Aspects of Itch

This project aims to investigate the relationship between different dimensions of catastrophizing (rumination, magnification, and helplessness) as well as some specific personality traits related to catastrophizing tendencies like anxiety sensitivity and fear sensitivity in the modulation of itch and pain intensities in an experimental setting.

Study Overview

Status

Status

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

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

Chronic itch severely affects the quality of life of patients by interfering with vital functions such as sleep, attention, and sexual activity, with an elevated expression of cognitive and emotional factors such as itch catastrophizing, worrying, as well as personality characteristics such as the predisposition to anxiety, depression, and suicidal thoughts that play an important role in the development, modification, and maintenance of itch. Moreover, chronic itch represents a significant socioeconomic burden due to a prevalence of around 10% in combination with largely suboptimal treatment since limited evidence has been found for the effectiveness of pharmaceutical interventions. The hypothesis of this project is that since it is well documented that the relationship between catastrophizing and pain and that itch and pain share many similarities, investigators can assume the existence of a similar connection between catastrophizing and itching.

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 (Estimated)

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.
46

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Silvia Lo Vecchio, PhD
  • Phone Number: +4521397785
  • Email: slv@hst.aau.dk

Study Contact Backup

  • Name: Giulia Erica Aliotta, PhD
  • Phone Number: 50290580
  • Email: gea@hst.aau.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9620
        • Recruiting
        • Aalborg University
        • Contact:
          • Silvia Lo Vecchio, PhD

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy men and women
  • 18-60 years
  • Speak and understand English

Exclusion Criteria:

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
  • Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
  • Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
  • Moles, scars, or tattoos in the area to be treated or tested.
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Acute or chronic pain
  • Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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.
Other: Histamine application
In the first session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill in other questionnaire. In second session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill out other questionnaires. The order will be randomized, so if the subjects were given the cowhage in the first session, they will receive the histamine application in the second session, and vice versa.
Other: Histamine
Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.
Other: Cowhage application
In the first session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill in other questionnaire. In second session, the subjects will fill some questionnaires. After that, a squared area of 4x4 cm will be selected at the center of each middle forearm of the subject and cowage or histamine will be applied for 10 minutes, during which the pain/itch following the cowhage/histamine application will be monitored with a VAS scale. After the itch-induction, the subjects will fill out other questionnaires. The order will be randomized, so if the subjects were given the cowhage in the first session, they will receive the histamine application in the second session, and vice versa.
Other: Cowhage
25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration.

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
Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).
Time Frame: Baseline 1st session
The Reinforcement Sensitivity Theory - Personality Questionnaire contains the following subscales: the Fight-Flight-Freeze System (FFFS, 10 items); the Behavioral Inhibition System (BIS, 23 items); and the Behavioral Approach System (BAS, 32 items). In total, 65 items have to be answered on a 4-point Likert-type scale ranging from 1 (not at all) to 4 (Highly).
Baseline 1st session
The Pittsburg Sleep Quality Index (PSQI)
Time Frame: Baseline 1st session
The PSQI consists of 19 items generating seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The seven component scores can be summarized in a global score ranging from zero to 21 with higher scores reflecting a worse overall quality of sleep.
Baseline 1st session
Depression, Anxiety, Stress Scale (DASS-21)
Time Frame: Baseline 1st session
The questionnaire measures the magnitude of depression, anxiety, and stress. Each of these three subscales consists of 7 questions answered using a 0-3 Likert scale, with 0 meaning "it did not apply to me", and 3 meaning "it applied to me very much"
Baseline 1st session
Positive And Negative Affect Schedule (PANAS)
Time Frame: Baseline 1st session
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement".
Baseline 1st session
Pain Catastrophizing Scale (PCS).
Time Frame: 10 minutes after every itch induction on 1st session
The PCS assesses negative and exaggerated coping concerning anticipated or experienced painful stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time).
10 minutes after every itch induction on 1st session
Itch Catastrophizing Scale (ICS).
Time Frame: 10 minutes after every itch induction on 1st session
The ICS assesses negative and exaggerated coping concerning anticipated or experienced itchy stimuli. Thirteen items have to be answered on a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (all the time).
10 minutes after every itch induction on 1st session
Learned Helplessness Scale (LHS)
Time Frame: 10 minutes after every itch induction on 1st session
The questionnaire consists of 20 items, and the participant's response to each item is rated on a 4-point Likert scale ranging from strongly agree (1) to strongly disagree (4).
10 minutes after every itch induction on 1st session
Positive And Negative Affect Schedule (PANAS)
Time Frame: 10 minutes after every itch induction on 1st session
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement".
10 minutes after every itch induction on 1st session
Depression, Anxiety, Stress Scale (DASS-21)
Time Frame: Baseline 2nd session (3 days after 1st session)
The questionnaire measures the magnitude of depression, anxiety, and stress. Each of these three subscales consists of 7 questions answered using a 0-3 Likert scale, with 0 meaning "it did not apply to me", and 3 meaning "it applied to me very much"
Baseline 2nd session (3 days after 1st session)
Positive And Negative Affect Schedule (PANAS)
Time Frame: Baseline 2nd session (3 days after 1st session)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement"
Baseline 2nd session (3 days after 1st session)
Pain Catastrophizing Scale (PCS).
Time Frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
The PCS assesses negative and exaggerated coping concerning anticipated or experienced painful stimuli. Thirteen items have to be answered on a 5-point Likert-type scale.
10 minutes after every itch induction on 2nd session (3 days after 1st session)
Itch Catastrophizing Scale (ICS).
Time Frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
The ICS assesses negative and exaggerated coping concerning anticipated or experienced itchy stimuli. Thirteen items have to be answered on a 5-point Likert-type scale.
10 minutes after every itch induction on 2nd session (3 days after 1st session)
Learned Helplessness Scale (LHS)
Time Frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
The questionnaire consists of 20 items, and the participant's response to each item is rated on a 4-point Likert scale ranging from strongly agree (1) to strongly disagree (4).
10 minutes after every itch induction on 2nd session (3 days after 1st session)
Positive And Negative Affect Schedule (PANAS)
Time Frame: 10 minutes after every itch induction on 2nd session (3 days after 1st session)
PANAS measures positive and negative affect dimensions. Positive affects (PA) are defined as "the extent to which a person feels active, enthusiastic, and alert". Negative affect (NA) is a condition of "general distress and unpleasable engagement"
10 minutes after every itch induction on 2nd session (3 days after 1st session)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of itch
Time Frame: 1 minute after every itch inductions
Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'.
1 minute after every itch inductions
Assessment of pain
Time Frame: 1 minute after every itch inductions
Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable'.
1 minute after every itch inductions

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.
Aalborg University

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.
April 27, 2024

Primary Completion (Estimated)

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.
December 31, 2025

Study Completion (Estimated)

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.
December 31, 2026

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).
March 19, 2024

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.
March 28, 2024

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.
April 1, 2024

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.
June 24, 2024

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.
June 19, 2024

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.
June 1, 2024

More Information

Terms related to this study

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.
  • N-20240004 3rd subproject

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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