An observational study in Body Hygiene Status in Bedbound Individuals, sponsored by Abant Izzet Baysal University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Abant Izzet Baysal University · Observational
This study aims to develop a valid and reliable assessment scale for evaluating body hygiene status in bedbound individuals. Maintaining body hygiene is an essential component of nursing care, particularly for patients who depend on others for daily activities.
The study is designed as a methodological study involving sequential qualitative and quantitative phases. Initially, semi-structured interviews will be conducted with intensive care nurses experienced in providing hygiene care to bedbound patients. The findings, together with relevant literature, will inform the development of an initial item pool.
Following item development and preliminary evaluation, the draft scale will be tested in at least 100 bedbound patients. Further psychometric evaluation will be conducted using a sample size determined according to the final number of scale items.
Body hygiene status will be assessed through observation during routine nursing care. No experimental treatment, invasive procedure, or additional medical intervention will be performed. The study aims to provide a standardized instrument to support the assessment of body hygiene status in bedbound individuals.
This methodological study aims to develop the Body Hygiene Status Assessment Scale for Bedbound Individuals and evaluate its validity and reliability. The study will be conducted at Bolu Izzet Baysal State Hospital, Türkiye, using sequential qualitative and quantitative phases.
**Phase 1: Qualitative Exploration and Item Development**
Individual semi-structured interviews will be conducted with approximately 10-15 intensive care nurses experienced in providing hygiene care to bedbound patients. Interviews will explore relevant anatomical regions, observable indicators of hygiene status, and nurses' professional experiences. Each interview is expected to last approximately 20-30 minutes, and interviews will continue until data saturation is reached. Findings from the qualitative phase and relevant literature will inform the development of the initial item pool.
**Phase 2: Preliminary Evaluation**
The draft scale will undergo preliminary evaluation to assess the clarity and feasibility of its items before pilot testing.
**Phase 3: Pilot Testing**
The pilot study will include at least 100 bedbound individuals meeting the eligibility criteria. Exploratory factor analysis and item analyses will be performed to examine the factor structure, refine the items, and determine the final number of scale items.
**Phase 4: Main Psychometric Evaluation**
Confirmatory factor analysis will be conducted in an independent sample that does not include participants from the pilot study. The main study sample size will be determined based on at least 10 participants per final scale item. The validity and reliability of the developed scale will be evaluated.
**Informed Consent and Participant Safety**
Written informed consent will be obtained directly from patients with decision-making capacity. For patients unable to provide informed consent, written consent will be obtained from their legally authorized representatives.
Body hygiene status will be assessed through direct observation during routine nursing care and hygiene procedures, only when the relevant anatomical regions are already visible. No additional exposure of body regions, invasive procedures, experimental treatments, or interventions beyond routine care will be performed. Patient privacy, comfort, and confidentiality will be maintained throughout the study.
The scale development process will be informed by contemporary measurement development principles and relevant COSMIN recommendations.
Abant Izzet Baysal University is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
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The study population will include intensive care nurses experienced in providing hygiene care to bedridden patients and adult bedridden inpatients. Nurses will participate in the qualitative phase to inform the development of scale items. Bedridden patients will participate in the subsequent pilot testing and psychometric validation of the scale.
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Qualitative Phase (Nurses):
Scale Development and Validation Phase (Patients):
Exclusion Criteria:
Approximately 10-15 intensive care nurses experienced in providing hygiene care to bedbound patients will participate in individual semi-structured interviews. The findings will inform the development of the initial scale item pool.
At least 100 bedbound patients meeting the eligibility criteria will be assessed using the draft Body Hygiene Status Assessment Scale. Exploratory factor analysis and item analyses will be performed to examine the preliminary factor structure and refine the scale items.
An independent sample of bedbound patients, excluding participants from the pilot study, will be evaluated using the refined Body Hygiene Status Assessment Scale. The sample size will be determined based on at least 10 participants per final scale item. Confirmatory factor analysis and reliability analyses will be conducted to evaluate the psychometric properties of the scale.
Construct Validity of the Body Hygiene Status Assessment Scale
Construct validity will be evaluated using exploratory factor analysis in the pilot sample of at least 100 bedbound patients and confirmatory factor analysis in an independent validation sample. Factor loadings, model fit indices, and the resulting factor structure will be examined.
Time frame: At the time of the single observational assessment during routine nursing care
Internal Consistency Reliability of the Body Hygiene Status Assessment Scale
Internal consistency reliability will be evaluated using Cronbach's alpha coefficient and item-total correlations. Reliability estimates will be calculated using data collected from bedbound patients assessed with the developed scale.
Time frame: At the time of the single observational assessment during routine nursing care
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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