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

Официальное название

Investigation of the Neurophysiological and Psychological Aspects of Itch

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). [Срок оценки: Baseline 1st session]
• The Pittsburg Sleep Quality Index (PSQI) [Срок оценки: Baseline 1st session]
• Depression, Anxiety, Stress Scale (DASS-21) [Срок оценки: Baseline 1st session]
• Positive And Negative Affect Schedule (PANAS) [Срок оценки: Baseline 1st session]
• Pain Catastrophizing Scale (PCS). [Срок оценки: 10 minutes after every itch induction on 1st session]
• Itch Catastrophizing Scale (ICS). [Срок оценки: 10 minutes after every itch induction on 1st session]
• Learned Helplessness Scale (LHS) [Срок оценки: 10 minutes after every itch induction on 1st session]
• Positive And Negative Affect Schedule (PANAS) [Срок оценки: 10 minutes after every itch induction on 1st session]
• Depression, Anxiety, Stress Scale (DASS-21) [Срок оценки: Baseline 2nd session (3 days after 1st session)]
• Positive And Negative Affect Schedule (PANAS) [Срок оценки: Baseline 2nd session (3 days after 1st session)]

Вторичные конечные точки (2)

• Assessment of itch [Срок оценки: 1 minute after every itch inductions]
• Assessment of pain [Срок оценки: 1 minute after every itch inductions]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Дания · 1 центр

• Aalborg University — Aalborg

Идентификаторы

NCT: NCT06340438 · N-20240004 3rd subproject

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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