Development of the pruritus-associated stress scale: a cross-sectional pilot study

Background: A significant relationship exists between perceived stress and the exacerbation and perpetuation of chronic pruritic dermatoses. Despite this, there is a notable absence of validated tools to specifically measure pruritus-associated stress.

Objective: To develop and pilot the Pruritus-Associated Stress Scale (PASS), a patient-reported outcome measure (PROM) for assessing pruritus-associated stress.

Patients and methods: Patients with chronic prurigo (CPG), atopic dermatitis (AD), and chronic pruritus on non-lesional skin (CPNL) were recruited at a German university center. They were interviewed on pruritus-associated stress, and perceived stress using the PSS-10 and PSQ-30 questionnaires, to compile the first PASS version in accordance with the guidelines for PROM development. Subsequently, a second patient cohort was interviewed to refine the items of the PASS instrument based on impact analysis, interitem and item-total correlation, and internal consistency reliability.

Results: Of 55 patients (15 with AD, 20 with CPG, and 20 with CPNL; 61.8% female; mean age 61.0 ± 15.4 years), who participated in the item selection phase, 94.5% reported pruritus-associated stress in the previous 2 weeks. The preliminary PASS demonstrated excellent internal consistency (Cronbach’s alpha = 0.91). The 12 items that showed strong impact scores addressed nervousness, therapeutic strategies for managing pruritus-associated stress, fatigue, and urges to scratch more frequently or intensely due to pruritus.

Conclusion: This pilot study yielded a preliminary PASS, identified poorly performing items, and collected information for further refinement. As a next step, retaining the full item pool, an exploratory factor analysis will be conducted in a larger sample.

Introduction

Chronic pruritus (CP) is “an unpleasant sensation of the skin and/or neighboring mucous membranes commonly triggering an urge so scratch,” and can arise in the context of a wide variety of underlying diseases (1, 2). According to the classification by the International Forum for the Study of Itch (IFSI), CP can be classified into three distinct clinical categories: Pruritus occurring on lesional skin (group I), as seen in conditions such as atopic dermatitis (AD), pruritus on non-lesional skin (CPNL; group II) and pruritus associated with chronic scratch lesions (group III), such as in chronic prurigo (CPG) (3). There is growing recognition that CP is a persistent physical symptom (synonymous with a persistent somatic symptom). This implies that the pruritus can persist even after the resolution of the original trigger or underlying disease, thereby becoming a significant health burden in its own right (4, 5).

CP is frequently accompanied by marked impairment in quality of life (QoL), and many patients report elevated levels of anxiety and depression, sleep disturbances, stigmatization, body dysmorphic concerns, and reduced overall wellbeing, all symptoms related to stress (4, 5). In addition, perceived stress is recognized as an important modulator of CP in various dermatoses (6–8). Stress modulates the course of skin diseases through both neuroimmunological and behavioral pathways. A key example is the itch-scratch cycle, which can exacerbate CP and skin inflammation, ultimately comprising the skin’s barrier function (9–13). Thus, targeted stress-reducing interventions may beneficially modulate the course of CP (5). Addressing psychological comorbidities may contribute to improved pruritus outcomes (14).

However, a significant challenge in both research and clinical settings is the under-recognition of assessment and therapeutic approaches regarding pruritus-associated stress, a problem compounded by the lack of a validated instrument for its assessment. So far, stress has most frequently been assessed using generic self-reporting tools, such as the Perceived Stress Scale-10 (PSS-10) or the Perceived Stress Questionnaire-30 (PSQ-30) (15, 16), which were not specifically designed for assessing pruritus-associated stress. In contrast to general perceived stress which is a broad biopsychosocial response to various internal or external stimuli, pruritus-associated stress specially refers to the emotional and physiological strain caused or amplified by CP, often resulting in a mutually reinforcing cycle between stress and CP (17). Without a pruritus-specific instrument, it is neither possible to systematically investigate the relationship between stress and CP using biomarkers, nor can the effectiveness of pharmacological or non-pharmacological interventions targeting pruritus-associated stress be reliably determined.

Therefore, the primary objective of the present cross-sectional cohort study is to develop and pilot a new questionnaire specifically designed to measure pruritus-associated stress, the Pruritus-Associated Stress Scale (PASS). Moreover, we aim to investigate and compare perceived stress in patients with CP of different origins, i.e., AD, CPNL, and CPG.

Materials and methods

Study design and setting

This is a prospective cohort study that has been ongoing at the Center for Chronic Pruritus (KCP) in Münster, Germany. The methods used are in accordance with the current recommendations for the development of PROMs (16).

Item generation

Following a narrative literature review to identify validated instruments for assessing perceived stress, a semi-structured interview was conducted with a cohort of adult CP patients (sufficiently fluent in the German language) who had AD, CPG, or CPNL (C1). Patients were asked a series of questions regarding pruritus-associated stress (Supplementary Table I), pruritus, pain, and scratching intensity, and requested to complete two validated stress questionnaires (PSS-10 and PSQ-30) (Figure 1).

FIGURE 1

Figure 1. Study flowchart. The figure presents both study phases (item generation and item selection) including recruited patient cohorts C1 and C2 as well as investigated demographics and patient-reported outcomes. AD, atopic dermatitis; CPG, chronic prurigo; CPNL, chronic pruritus on non-lesional skin; DLQI, Dermatology Life Quality Index; HADS, Hospital Anxiety and Depression Scale; PSS-10, Perceived Stress Scale; PSQ-30, Perceived Stress Questionnaire.

Items from the interview were selected and incorporated into the preliminary PASS, if at least two-thirds of the patients had rated them as relevant (yes or no) for pruritus-associated stress.

PSS-10 and PSQ-30 items were selected for inclusion in the preliminary PASS if they had an impact score in the upper third of distribution. The impact scores of the PSS-10 and PSQ-30 items were determined by first calculating the item importance: for each response option on the respective Likert scale, the respective scale value was multiplied by the number of patients who selected that option. These products were summed and then divided by the total number of responses to obtain the mean importance rating for each item. The item impact was then computed by multiplying the item importance by the proportion of patients who rated the item as important.

Item selection

A new analogous cohort of patients with CP (C2) was subsequently recruited and surveyed specifically regarding pruritus-associated stress using the preliminary PASS which was composed out of 25 items. Additional PROMs were used to evaluate perceived stress (PSS-10, PSQ-30) (15, 16); quality of life, including the Dermatology Life Quality Index (DLQI, range 0–30) (18) and the pruritus-specific ItchyQol (range 22–110) (19, 20); and anxiety and depression via the Hospital Anxiety and Depression Scale (HADS, ranges 0–21) (21) Figure 1).

The pruritus intensity over the previous 24 h was assessed using an NRS, capturing both average (AP-NRS) and maximum (WP-NRS) CP intensity (range 0–10) (22). Additionally, the average frequency of scratching, the highest intensity of scratching, and the highest intensity of pain experienced within the previous 24 h were assessed using a NRS (0 = no, 10 = worst imaginable).

All participants provided both oral and written informed consent prior to enrollment. The study received approval from the Ethics Committee of the State Medical Association of Westfalen-Lippe, Münster, Germany (reference number: 2024-884-f-S).

Interitem correlation and item-total correlation

Interitem and item-total correlations of the proposed PASS items were calculated to identify redundancies. To evaluate the internal structure of the preliminary PASS scale, bivariate Pearson’s inter-item correlations among all scale items were calculated. Values between 0.15 and 0.50 were considered optimal (23, 24). To assess the discriminative power of each item, corrected item-total correlations were calculated. Items with values below 0.30 may not adequately measure the underlying construct captured by the scale as a whole and were flagged for potential removal (24).

Impact analysis

During the item selection phase, patients indicated on evaluation forms how often they had experienced the PASS items in the past 2 weeks (ranging from 0 to 4, with 0 indicating “never” and 4 indicating “very often”) and rated the importance of each item (responding with “yes” or “no”). The frequency of each item was calculated as the percentage of respondents who had experienced the respective item. The item impact score was then derived by multiplying its frequency by the percentage of patients who had rated the item as important among all patients. Items with an impact score below 2.3 were considered of low relevance and might be excluded from the final version of the PASS.

Internal consistency reliability

After the final set of items was determined through impact analysis, the internal consistency reliability of the scale was evaluated by calculating Cronbach’s alpha coefficient. The interpretation of Cronbach’s alpha values was as follows: below 0.60, unacceptable; 0.60–0.65, undesirable; 0.65–0.70, minimally acceptable; 0.70–0.80, respectable; and above 0.80, indicated very good internal consistency (24, 25).

Between-group comparisons analysis

Due to the exploratory study design, group comparisons of PROMs used the Kruskal-Wallis test without adjustments for multiple comparisons. If statistically significant differences were found between the three disease groups, pairwise comparisons between two groups were conducted using the Mann-Whitney U-test.

Statistical analysis

All analyses were performed with SPSS software (IBM SPSS Statistics, version 29; IBM, Armonk, NY). Results with p < 0.05 were considered statistically significant.

Results

Participants and patient-reported outcomes

Demographics and PROMs of all patients who participated in the item generation phase (C1; n = 31, mean age 51.03 ± 15.64 years) and of all patients who took part in the item-selection phase (C2; n = 55; mean age 61.02 ± 15.35 years) are presented in Table 1.

TABLE 1

Table 1. Patient characteristics.

A total of 55 patients participated in the item-selection phase (61.8% female; n = 15 with AD, n = 20 with CPG, and n = 20 with CPNL). The highest pruritus intensity during the past 24 h was moderate (mean WP-NRS 6.38 ± 2.28), and the highest pain intensity was mild (mean worst-pain NRS 4.22 ± 3.21).

Quality of life was moderately to severely impaired (DLQI 11.11 ± 7.84; ItchyQoL 98.31 ± 36.03). Anxiety levels were elevated (8.76 ± 4.34) and depression levels were within normal ranges (Table 1). Perceived stress was moderate (PSS-10 20.81 ± 7.23; PSQ-Index 0.48 ± 0.20).

PASS item selection

A total of 25 items from the questionnaire were analyzed to assess reliability and item characteristics. The internal consistency of the scale was excellent, as indicated by a Cronbach’s alpha of 0.905 and a standardized Cronbach’s alpha of 0.910.

Scale and summarized item statistics

Across all items, the means ranged from 1.60 (± 0.92) to 2.96 (± 1.11) (overall mean 2.38, range 1.36, max/min ratio 1.85, variance 0.19). On the scale level, the mean total score was 59.42 with a standard deviation of 13.75 and a variance of 189.14. Detailed item statistics (mean, standard deviation) are presented in Table 2.

TABLE 2

Table 2. Item descriptive and item-total statistics.

Item-total statistics

Only item 20 exhibited an item-total correlation below 0.30, indicating that its removal from the final PASS should be considered in future evaluations. The remaining item-total correlations ranged between 0.36 and 0.75 (Table 2).

Inter-item correlations

The inter-item correlation matrix is presented in Table 3. There were only a few inter-item correlations with coefficients of 0.7 or higher, which will need to be evaluated for potential removal in the next stage of the study.

TABLE 3

Table 3. Inter-item correlation matrix.

Item impact

As shown in Table 4, the range of calculated item impacts was between 1.46 and 2.96. Twelve out of 25 items achieved an item impact of 2.3 or higher and should therefore be considered for inclusion in the final version of the PASS. The three items with the highest item impact addressed therapeutic strategies for managing pruritus-associated stress, fatigue, and urges to scratch more frequently or intensely.

TABLE 4

Table 4. Item Impact Scores and inter-item correlations.

Comparison of patients with AD, CPNL, and CPG

The Kruskal-Wallis test revealed no statistically significant differences among the three disease groups with respect to age, gender, mean pruritus intensity over the past 24 h, mean scratching frequency in the past 24 h, highest scratching intensity in the last 24 h, highest pain intensity in the last 24 h, or anxiety and depression levels (all p > 0.05). There were also no significant differences in perceived stress levels [PSS-10: Kruskal-Wallis H(2) = 2.10, p = 0.35; PSQ-30: Kruskal-Wallis H(2) = 0.58, p = 0.75].

However, the groups differed significantly in terms of the worst pruritus intensity experienced during the last 24 h [Kruskal-Wallis H(2) = 6.984, p = 0.030]. Patients with CPNL reported a significantly higher worst pruritus intensity during the previous 24 h than patients with AD (7.45 ± 2.09 vs. 5.40 ± 2.44, Mann-Whitney U = 77.00, Z = –2.46, p = 0.014).

Significant group differences emerged for three of the 25 potential PASS items: Nervousness [item 1, Kruskal-Wallis H(2) = 6.08, p = 0.048], irritability [item 3, Kruskal-Wallis H(2) = 8.62, p = 0.013], and attempts to distract oneself to cope with pruritus-associated stress [item 7, Kruskal-Wallis H(2) = 7.63, p = 0.022]. Specifically, patients with CPNL reported feeling nervous as a result of pruritus-associated stress significantly more frequently within the past 2 weeks than patients with AD (Mann-Whitney U = 87.50, Z = –2.19, p = 0.036). Patients with AD reported experiencing irritability due to pruritus-associated stress significantly more often than those with CPNL (Mann-Whitney U = 71.50, Z = –2.76, p = 0.008), and also patients with CPG reported irritability more frequently than CPNL patients (Mann-Whitney U = 125.50, Z = –2.13, p = 0.043). Regarding coping behaviors, patients with CPG reported significantly more frequent attempts to distract themselves in response to pruritus-associated stress compared to CPNL patients (Mann-Whitney U = 113.00, Z = –2.42, p = 0.018); similarly, such attempts were significantly more common among patients with AD than among those with CPNL (Mann-Whitney U = 85.50, Z = –2.25, p = 0.030).

Discussion

In CP, a complex, multidirectional interplay exists between pruritus-related stress, neuroimmune inflammation, and skin barrier dysfunction. Pruritus can induce stress and be induced by stress. Within this dynamic, stress also compromises the integrity of the skin barrier, rendering it more susceptible to further irritation and inflammation (26, 27). Therefore, developing a scale to specifically evaluate pruritus-associated stress is crucial for guiding appropriate treatment, not only to improve patients’ quality of life but also to meaningfully influence and modulate disease progression. Consequently, in this study, we included patients from all three clinical groups affected by CP: Patients with AD (IFSI I), CPNL (IFSI III) and CPG (IFSI III).

Demographics were comparable among the three groups. The majority of assessed PROMs including pruritus and pain intensities as well as depression scores indicated moderate levels. In contrast, quality of life measures revealed severe impairment, while anxiety scores were predominantly within the borderline abnormal range. Interestingly, the perceived stress levels were also moderate, albeit higher than in the general population without CP (16, 28). Thus, the sample was suitable for the study’s objective of developing and piloting the PASS. The groups differed significantly in terms of the worst pruritus intensity experienced during the last 24 h and ItchyQol. This was expected and welcome for the development of a PASS suitable for CP of various origins. It is known that these pruritus-affected groups differ in terms of scratching behavior (CPNL: low-intensity, CPG: high-intensity), the high prevalence of CPNL, and the higher levels of the two most frequent comorbidities of CP (anxiety and depression) in CPNL and CPG compared to AD (29, 30).

The literature review, the structured interview, and the responses to the PSS-10 and PSQ-30 enabled the generation of 25 PASS items. The two questionnaires were included because they are validated and widely used for stress assessment, and we wanted to include suitable stress indicators in the PASS. Additionally, the PSS-10 was selected because there are existing studies in which perceived stress in patients with dermatological conditions was specifically measured using the PSS-10, providing relevant prior data for this population (31–36).

As part of this study, all 25 preliminary items were administered to assess their psychometric properties prior to item reduction and exploratory factor analysis (EFA) in a larger sample. The current analyses aimed to identify poorly performing items and inform item refinement, while retaining the full item pool for subsequent factor-analytic procedures.

Item-level statistics included descriptive indices (mean, standard deviation, skewness, and kurtosis), corrected item–total correlations, inter-item correlations, and a participant-weighted item impact score (i.e., importance × frequency). Items 1 (nervousness), 2 (restlessness), 3 (irritability), 5 (pruritus), 6 (urge to scratch), 8 (therapeutic interventions), 10 (good physical state), 18 (valued activities), and 22–25 (mental exhaustion, emotional tension, feeling of being rushed, feeling rested) showed satisfactory strong results across all indices and are considered psychometrically and substantively robust. Several items [e.g., 7 (distraction), 11–16 (relaxation, strain from social contacts, thoughts of worries, feeling of problem-solving ability, feeling of control, anger over uncontrollable things), 19 (fun)] demonstrated moderate performances, with acceptable but somewhat lower item-total correlations or limited relevance, suggesting the need for potential revision (Table 4).

Items 17 (fatigue) and 20 (feeling of being overwhelmed) proved to be problematic. Item 20 showed a very weak item-total correlation (rit = 0.11), numerous negative inter-item correlations, and limited experienced relevance, marking it as a likely candidate for removal. Item 17 was perceived as relevant (impact = 2.73) but showed a minimal correlation with the rest of the scale (mean r = 0.15), suggesting it may reflect a distinct construct or an interpretation issue.

Despite these findings, no items will be excluded at this stage to allow a comprehensive item set to be evaluated via an EFA in a larger sample (n ≈ 240) (37). This approach aims to ensure that potential factor structures are not prematurely constrained, allowing for the empirical determination of item groupings and loadings.

The group comparison showed statistically significant differences for three items, two of high relevance (nervousness and irritability) and one of lower relevance (distraction). These results correspond to those of the worst itch intensity and quality of life of the respective group and support the inclusion of all items for a valid item reduction with a larger sample.

This cross-sectional, pilot study was the first step in developing a pruritus-associated stress scale for CP. Several of the generated scale items achieved an impact score above the defined suitability limit (2.3). Future phases of the study will focus on further item reduction and the validation of the PASS.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its Supplementary material.

Ethics statement

The studies involving humans were approved by Reviewed and approved by the Ethics Committee of the State Medical Association of Westfalen-Lippe, Münster, Germany; approval # 2024-884-f-S. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.

Author contributions

SR: Formal analysis, Writing – original draft, Visualization, Data curation, Writing – review & editing, Validation, Conceptualization, Investigation, Methodology. JP: Data curation, Investigation, Writing – review & editing. AW: Data curation, Methodology, Formal analysis, Validation, Writing – review & editing, Supervision, Conceptualization. NK: Formal analysis, Data curation, Methodology, Conceptualization, Validation, Writing – review & editing. BL: Project administration, Supervision, Writing – review & editing, Funding acquisition. CM: Writing – review & editing. CZ: Writing – review & editing. FW: Writing – review & editing, Investigation. KA: Conceptualization, Writing – review & editing. HW: Writing – review & editing. SWS: Writing – review & editing, Funding acquisition, Project administration, Conceptualization, Validation, Methodology, Supervision. SS: Methodology, Conceptualization, Validation, Funding acquisition, Project administration, Resources, Writing – review & editing, Supervision, Formal analysis.

Funding

The author(s) declare financial support was received for the research and/or publication of this article. This German Research Foundation for funded the research unit 5211 (RU5211) SOMACROSS (DFG project number 445297796; STA 1159/7-1, SCHN 657/5-1; SCHN 474/9-1) and for funding the research unit PRUSEARCH (FOR 2690; STA 1159/4-2). The funding sources did not participate in study design and conduct, nor in the data collection, management, analysis, and interpretation, nor in the preparation, review, or approval of the manuscript, nor in the decision to submit the article for publication.

Acknowledgments

We thank Helena Karajiannis, PhD, HK Scientific Consulting, for the writing assistance.

Conflict of interest

Svenja Royeck was an advisor, speaker, or investigator for Incyte Inc., Eli Lilly, LEO Pharma, and Sanofi/Regeneron outside the submitted work. Claudia Zeidler is an investigator for Novartis, Janssen, Pfizer, UCB, Lilly, Abbvie, Boehringer Ingelheim, Sanofi, Regeneron, Leo, Galderma and has received speaker honoraria/travel fees from Dermasence, Beiersdorf, Leo, Sanofi, Novartis, Unna Akademie, Almirall and AbbVie outside the submitted work. Bernd Löwe reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the European Commission’s Horizon 2020 Framework Programme, the European Joint Programme for Rare Diseases (EJP), the Ministry of Science, Research and Equality of the Free and Hanseatic City of Hamburg, Germany, and the Foundation Psychosomatics of Spinal Diseases, Stuttgart, Germany. He received remunerations for several scientific book articles from various book publishers, from the Norddeutscher Rundfunk (NDR) for interviews in medical knowledge programmes on public television, and as a committee member from Aarhus University, Denmark. He received travel expenses from the European Association of Psychosomatic Medicine (EAPM), and accommodation and meals from the Societatea de Medicina Biopsyhosociala, Romania, for a presentation at the EAPM Academy at the Conferinţa Naţională de Psihosomatică, Cluj-Napoca, Romania, October 2023. He received a travel grant for a lecture on the occasion of the presentation of the Alison Creed Award at the EAPM Conference in Lausanne, 12–15 June 2024. He received remuneration and travel expenses for lecture at the Lindauer Psychotherapiewochen, April 2024. He is President of the German College of Psychosomatic Medicine (DKPM) (unpaid) since March 2024 and was a member of the Board of the European Association of Psychosomatic Medicine (EAPM) (unpaid) until 2022. He is member of the EIFFEL Study Oversight Committee (unpaid). Angelika Weigel reports research funding (no personal honoraria) from the Werner Otto Foundation. She has received remunerations for a lecture at the Lindauer Psychotherapietage and she has been treasurer of the EAPM (unpaid) until 2023. Volker Huck has received research funding from LEO Pharma GmbH in terms of an investigator-initiated trial outside the submitted work. Stefan W. Schneider was speaker and/or consultant funding from Almirall S. A., GSK R&D Ltd., Incyte Corporation, LEO Pharma GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, Sanofi-Aventis Deutschland GmbH, Pfizer Pharma GmbH. Christoph Schramm was consultant for Pliant Therapeutics, Chemomab, Agomab, Amgen and Moonlake and received honoraria for lectures from Falk Foundation. Sonja Ständer was speaker and/or consultant and/or Investigator and/or has received research funding from Amgen Inc., Almirall S. A., Celldex Therapeutics Inc., Clexio Biosciences Ltd., Focus-Insight Healthtech Group Co. Ltd., Galderma Laboratorium GmbH, Galderma R & D, LLC., Galderma SA, Klirna Biotech Inc., GSK R&D Ltd., Incyte Corporation, LEO Pharma GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, P. G. Unna Academy, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis R& D, Sanofi Genzyme Corporation, TouchIME, Vifor Pharma Deutschland GmbH.

The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Supplementary material

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fmed.2025.1683259/full#supplementary-material

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