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

NCT06340438 | Recruiting DMC

• 1 other identifier: N-20240004 3rd subproject
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Histamine; Cowhage

Outcome Measures

Primary Outcomes (14)

• Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).

  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)

  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)

  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)

  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).

  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).

  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)

  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)

  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)

  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)

  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).

  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).

  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)

  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)

  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 Outcomes (2)

• Assessment of itch

  1 minute after every itch inductions

• Assessment of pain

  1 minute after every itch inductions

Study Arms (2)

Histamine application

OTHER

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

Cowhage application

OTHER

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

Interventions

Histamine OTHER

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.

Histamine application

Cowhage OTHER

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.

Cowhage application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, 9620, Denmark

RECRUITING

MeSH Terms

Interventions

Histamine

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Silvia Lo Vecchio, PhD

CONTACT

+4521397785; slv@hst.aau.dk

Giulia Erica Aliotta, PhD

CONTACT

50290580; gea@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded about application of pruritogens.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The participants will randomly receive applications of cowhage and histamine.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 1, 2024
• Study Start: April 27, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

DK (1)