Body Hygiene Status in Bedbound IndividualsNCT07905794
Development of a Body Hygiene Assessment Scale for Bedbound Individuals
An observational study of Body Hygiene Status in Bedbound Individuals, run by Abant Izzet Baysal University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Hygiene Status in Bedbound Individuals
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Qualitative Phase (Nurses):
- Aged 18 years or older.
- Intensive care nurses experienced in providing hygiene care to bedridden patients.
- Voluntary participation in individual interviews.
- Scale Development and Validation Phase (Patients):
- Aged 18 years or older.
- Bedridden patients receiving inpatient care.
- Eligible for hygiene assessment during routine nursing care.
Who cannot join
- Not meeting the inclusion criteria for the relevant study phase.
- Declining participation or withdrawing consent, where applicable.
- Any additional exclusion criteria specified in the approved study protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of a Body Hygiene Status Assessment Scale for Bedbound Individuals
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Bedbound Patients, Body Hygiene, Scale Development, Validity and Reliability, Psychometric Evaluation, Nursing Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Qualitative Interview Group | 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. | |
| Pilot Psychometric Evaluation Group | 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. | |
| Main Psychometric Validation Group | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of the single observational assessment during routine nursing care
Secondary outcomes (1)
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.
Measured: At the time of the single observational assessment during routine nursing care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Hygiene Status in Bedbound IndividualsStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Can Çiçek, Abant Izzet Baysal University
- Investigators
- Saadet Can Çiçek, Assoc. Prof., PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905794
- Sponsor's protocol ID
- AIBU- SBF- NDS- 2026
- Other IDs
- 2026/427
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Body Hygiene Status Assessment Scale for Bedbound Individuals
- ClinicalTrials.gov ID
- NCT07905794
- Acronym / sponsor ID
- AIBU- SBF- NDS- 2026
- Keywords
- Bedbound Patients, Body Hygiene, Scale Development, Validity and Reliability, Psychometric Evaluation, Nursing Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qualitative Interview Group | – | –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. |
| Pilot Psychometric Evaluation Group | – | –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. |
| Main Psychometric Validation Group | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Aged 18 years or older.
- Intensive care nurses experienced in providing hygiene care to bedridden patients.
- Voluntary participation in individual interviews.
- Aged 18 years or older.
- Bedridden patients receiving inpatient care.
Key exclusion criteria (3 listed)
- Not meeting the inclusion criteria for the relevant study phase.
- Declining participation or withdrawing consent, where applicable.
- Any additional exclusion criteria specified in the approved study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Construct Validity of the Body Hygiene Status Assessment Scale
Time frame: At the time of the single observational assessment during routine nursing care
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.
1 secondary outcome
Internal Consistency Reliability of the Body Hygiene Status Assessment Scale
Time frame: At the time of the single observational assessment during routine nursing care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saadet Can Çiçek, Assoc. Prof., PhD principal investigator
Abant Izzet Baysal University
Questions about this trial
What is this clinical trial studying?
An observational study of Body Hygiene Status in Bedbound Individuals, run by Abant Izzet Baysal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saadet Can Çiçek, PhD (+90 506 284 69 36, saadet.cancicek@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct Validity of the Body Hygiene Status Assessment Scale (time frame: At the time of the single observational assessment during routine nursing care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.