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NCT Number: NCT07552792

Impact of Hand Rub Placement on Patient Trust and Disease Stigma

This study aims to investigate how the physical placement of hand sanitizer in consultation rooms affects patient trust and feelings of disease stigma. While hand hygiene is an essential infection control measure in healthcare, performing it immediately in front of patients with visible, non-communicable conditions (such as psoriasis) might inadvertently make patients feel rejected or stigmatized.This study uses a randomized controlled design to evaluate if a simple environmental modification-changing the spatial location of the hand sanitizer-can naturally nudge physicians to alter their hand hygiene timing without compromising safety. Researchers will discreetly observe the hand hygiene behavior of outpatient dermatologists and ask participating psoriasis patients to complete a brief, anonymous questionnaire regarding their trust in the physician, feelings of stigma, and overall satisfaction with the consultation. The goal is to provide evidence for patient-centered hospital space designs that protect patient psychological well-being while maintaining hygiene standards.

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Key information

About this study

Background and Rationale:

Patients with visible non-communicable diseases, such as psoriasis, often experience high levels of disease-related stigma and are highly sensitive to physician behaviors. Although hand hygiene is a cornerstone of infection control, executing it in certain clinical scenarios may be misinterpreted by patients as the physician's "fear" or "disgust" toward their condition. This misinterpretation can exacerbate their psychological burden and impair the doctor-patient relationship. Environmental engineering theories suggest that micro-modifications to physical hospital spaces can significantly alter medical behavior patterns (such as sitting versus standing during consultations) without relying on resource-intensive training or administrative supervision.Study Design and Methodology:

This is a single-center, double-blind, randomized controlled deception trial conducted in an outpatient dermatology setting. The core intervention involves manipulating the spatial location of the hand sanitizer in the consultation room through randomized assignment to determine its causal effect on physician behavior and subsequent patient psychological outcomes. To minimize the Hawthorne effect and behavioral bias, a double-blind deception mechanism is employed. Physicians are informed that the study is simply for medical students to observe general consultation workflows, while patients are told they are participating in a routine outpatient service satisfaction survey. The true nature of the environmental intervention and its behavioral focus is concealed until a debriefing session at the conclusion of the study.Observations and Assessments:

During the study, trained observers will discreetly record the physicians' hand hygiene patterns in the consultation room. After the consultation concludes, participating psoriasis patients will be guided to an independent area to complete an anonymous electronic questionnaire (taking approximately 10 minutes).The primary psychological outcomes assessed include:Doctor-patient trust, measured by the 11-item Trust in Physician Scale (TPS).Intensity of disease stigma, measured by the 27-item Chinese version of the Feelings of Stigma Questionnaire (FSQ).Secondary outcomes include overall patient satisfaction evaluated across five dimensions, and the documentation of physician hand hygiene timing patterns under different environmental layouts.Statistical Analysis:

Analyses will utilize a prospectively defined dataset framework. Multivariate linear regression will be used to analyze the psychological impact pathways on trust and stigma, adjusting for demographic variables. Generalized estimating equations (GEE) and mixed linear models will be applied for sensitivity analyses to account for the correlation of multiple observations from the same physician.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For Patients:

  • Aged 18 years or older.
  • Diagnosed with psoriasis and receiving treatment at the designated psoriasis specialty outpatient clinic during the study period.
  • Legally capable of signing the informed consent form and cognitively able to understand and complete the questionnaire (independently or with assistance from family members).

For Physicians:

  • Hold a registered practicing qualification in the Dermatology Department of Huashan Hospital Pudong Branch and are qualified for independent outpatient consultations.
  • Scheduled to continuously undertake outpatient work in the designated consultation rooms during the study period.
  • Voluntarily sign the informed consent form for behavioral observation.

Exclusion criteria

For Patients:

  • Severe visual, hearing, or speech impairments leading to basic doctor-patient communication barriers.
  • Diagnosed with psychiatric disorders (e.g., schizophrenia, severe depression) that, as assessed by a specialist, may interfere with the authenticity of the questionnaire responses.
  • Presenting with a clinical state requiring emergency treatment during the visit, such as acute infection of skin lesions or generalized pustules.

For Physicians:

  • Non-permanent practicing staff of the hospital, such as visiting physicians or rotating medical students.
  • Unable to independently perform hand hygiene procedures due to physical/limb dysfunction.

Treatment and study plan

Distant placement of hand rub

Other

The alcohol-based hand rub dispenser is relocated to a distant position in the consultation room, greater than 1 meter (approx. 3.3 feet) away from the physician (e.g., on a sink). This environmental modification is designed to prompt physicians to perform hand hygiene after the patient departs ("invisible hand hygiene"), aiming to improve patient trust and reduce perceived disease-related stigma.

Conventional placement of hand rub

Other

The alcohol-based hand rub dispenser is placed in the conventional, standard position in the consultation room, which is less than or equal to 0.3 meters (approx. 1 foot) away from the physician (e.g., to the left of the computer). This facilitates standard hand hygiene immediately after patient contact ("visible hand hygiene").

Primary outcomes

  1. Proportion of Invisible Hand Hygiene Events

    Time frame: Assessed during the outpatient consultation (average 10-15 minutes per consultation).

    Hand hygiene behavior was observed and categorized into "visible hand hygiene" (immediate post-contact cleansing before patient departure) and "invisible hand hygiene" (cleansing after patient departure). A positive outcome is defined as handwashing occurring after the patient leaves (invisible hand hygiene). The outcome is reported as the proportion of consultations where invisible hand hygiene occurred.

  2. Patient Trust in Physician Scale (TPS) Score

    Time frame: Assessed immediately after the outpatient consultation.

    Patient trust was measured using the 10-item Trust in Physician Scale (TPS), a validated tool using a 5-point Likert scale to assess trust in the physician's competence, communication, and prioritization of patient interests. Results are expressed as percentages of total possible scores (range 0-100%). Higher scores indicate a higher level of trust in the physician.

  3. Feelings of Stigma Questionnaire (FSQ) Score

    Time frame: Assessed immediately after the outpatient consultation.

    Perceived disease stigma was measured using the 28-item modified Feelings of Stigma Questionnaire (FSQ), which uses a 6-point scale to assess subjective experiences of stigma across domains including self-stigma, social exclusion, privacy management, and emotional impact. Results are expressed as percentages of total possible scores (range 0-100%). Higher scores indicate higher levels of perceived disease stigma.

Secondary outcomes

  1. Patient Satisfaction Score

    Time frame: Assessed immediately after the outpatient consultation.

    Exploratory outcome evaluating patient satisfaction with the consultation process. This covers domains including private consultations, service attitude, disease/treatment explanations, follow-up arrangements, and privacy protection. Assessed via 5-point Likert scales, where higher scores indicate greater patient satisfaction.

Study contacts

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

Juan Du, MD

CONTACT

[email protected]

+86-13601821207

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

The Impact of Hand Rub Placement on Hand Hygiene Sequence, Patient Trust, and Disease Stigma: A Randomised Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2026
Registry last updated
Apr 27, 2026

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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