Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Histamine, Cowhage.
- Who it may be relevant to
- Registry conditions: Histamine, Cowhage. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of the Neurophysiological and Psychological Aspects of Itch
Overview
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.
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.
Interventions
- 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
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 outcome measures
- Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). [Time frame: Baseline 1st session]
- The Pittsburg Sleep Quality Index (PSQI) [Time frame: Baseline 1st session]
- Depression, Anxiety, Stress Scale (DASS-21) [Time frame: Baseline 1st session]
- Positive And Negative Affect Schedule (PANAS) [Time frame: Baseline 1st session]
- Pain Catastrophizing Scale (PCS). [Time frame: 10 minutes after every itch induction on 1st session]
- Itch Catastrophizing Scale (ICS). [Time frame: 10 minutes after every itch induction on 1st session]
- Learned Helplessness Scale (LHS) [Time frame: 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]
- Depression, Anxiety, Stress Scale (DASS-21) [Time frame: Baseline 2nd session (3 days after 1st session)]
- Positive And Negative Affect Schedule (PANAS) [Time frame: Baseline 2nd session (3 days after 1st session)]
Secondary outcome measures (2)
- Assessment of itch [Time frame: 1 minute after every itch inductions]
- Assessment of pain [Time frame: 1 minute after every itch inductions]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Aalborg University — Aalborg
Identifiers
NCT: NCT06340438 · N-20240004 3rd subproject