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NCT Number: NCT06340438

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

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.

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Key information

Conditions

Histamine Cowhage

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, 9620, Denmark

Location status: Recruiting

Location contact

Silvia Lo Vecchio, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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"

  4. 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".

  5. 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).

  6. 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).

  7. 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).

  8. 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".

  9. 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"

  10. 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"

  11. 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.

  12. 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.

  13. 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).

  14. 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"

Secondary outcomes

  1. 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'.

  2. 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'.

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Erica Aliotta, PhD

CONTACT

[email protected]

50290580

Silvia Lo Vecchio, PhD

CONTACT

[email protected]

+4521397785

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Investigation of the Neurophysiological and Psychological Aspects of Itch

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2024
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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