NCT07887009

Brief Summary

The goal of the study is to verify how healthcare professionals in the Intensive Care Unit (ICU) experience the presence of family members before and after a more flexible visiting policy is introduced. The main question is : Does attitude and perception of the ICU staff regarding family presence in the ICU change after a period during which a more flexible visitation policy was implemented in daily care? Additional exploratory primary question Is sensitivity to stress related to the initial attitudes and perceptions of ICU- staff regarding family presence in the ICU, and to the way these attitudes and perceptions change after a period of implementation and adjustment to the more flexible visitation policy? The study consists of two main measurements: Participants will be asked to complete a questionnaire before the change in visiting policy and again several months after the new policy has been introduced. The study also looks at which factors may make family presence feel more supportive or more demanding for healthcare professionals. Therefor some participants may also complete a short questionnaire about their experiences during work shifts. The visiting policy itself is part of routine ICU care and is not decided by the study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Dec 2027

Study Start

First participant enrolled

September 29, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

1.2 years

First QC Date

October 5, 2026

Last Update Submit

October 19, 2026

Conditions

Keywords

Intensive Care UnitICU stafffamily presencevisiting policystaff attitudesstaff experienceadaptationfamily-centered careBAVIQstress sensitivityIPIP-NEO

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline in healthcare providers'attitudes and perceptions regarding family presence in the adult ICU (Intensive Care Unit)

    The change in healthcare providers' attitudes and perceptions is measured using the BAVIQ score prior to the introduction of the more flexible visitation policy (baseline) and six months after implementation (Follow-up) . The primary out is the change in the BAVIQ score between the baseline measurements and Follow-up. No predifined threshold is used; scores are analysed as continuous measures. Time points: T0 = baseline time point, before implementation of the extended visiting policy. T1 = implementation time point, during the early implementation period of the extended visiting policy. T2 = follow-up time point, approximately 6 months after implementation of the extended visiting policy.

    Baseline (T0) assessed once before implementation of the extended visiting policy. Follow- up (T2) assessed once approximately 6 months after implementation of the extended visiting policy.

  • association between individual vulnerability to stress and overload and attitudes and perceptions regarding family presence.

    The susceptibility to individual vulnerability to stress and overload is measured using the IPIP-NEO facet scales for Anxiety and Vulnerability at baseline. The outcome measures are the IPIP-NEO Anxiety and Vulnerability facet scores, their association with the BAVIQ score at baseline, and their association with the change in the BAVIQ score between baseline and follow up. Time points: T0 = baseline time point, before implementation of the extended visiting policy. T1 = implementation time point, during the early implementation period of the extended visiting policy. T2 = follow-up time point, approximately 6 months after implementation of the extended visiting policy.

    Baseline (T0) assessed once before implementation of the extended visiting policy.

Secondary Outcomes (1)

  • factors that may influence the ICU staff 's experience of family presence during care

    T1: implementation period: assessed during a 2-week data collection period during the early implementation period of the extended visiting policy

Study Arms (1)

questionnaire on attitudes and validation of family participation on ICU

OTHER

questionnaire

Other: questionnaire

Interventions

the study focusses specifically on staff attitudes, experiences and adaptation over time, and on factors that may influence whether family presence is experienced as supportive or demanding.

questionnaire on attitudes and validation of family participation on ICU

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthcare professionals working in the adult Intensive Care Unit (ICU)
  • direct involvement in patient care

You may not qualify if:

  • healthcare professionals in training
  • healthcare professionals working in pediatric intensive care members of the research team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis

Brussels, 1090, Belgium

Location

Related Publications (6)

  • Ning J, Cope V. Open visiting in adult intensive care units - A structured literature review. Intensive Crit Care Nurs. 2020 Feb;56:102763. doi: 10.1016/j.iccn.2019.102763. Epub 2019 Oct 23.

    PMID: 31668437BACKGROUND
  • Duque PA, Quintero Duque S. Open-Door ICU Model and Humanized Care: A Systematic Review. Nurs Rep. 2025 Nov 18;15(11):406. doi: 10.3390/nursrep15110406.

    PMID: 41295830BACKGROUND
  • de la Cueva-Ariza L, Delgado-Hito P, Lluch-Canut MT, Momblan MAM, Benito-Aracil L, Via-Clavero G, Cabellos CC, Romero-Garcia M. Improving Family-Centred Care in Intensive Care Units: Participatory Action Research to Design and Implement Changes in Nursing Care. Nurs Crit Care. 2026 May;31(3):e70512. doi: 10.1111/nicc.70512.

    PMID: 42132067BACKGROUND
  • Chen K, Zhang C, Wu Y, Yue W, Zhang X, Han L, Zhang Z. Attitudes of healthcare providers and patients/families toward a family-centered visitation and care program: a qualitative study. Front Med (Lausanne). 2026 Apr 2;12:1655210. doi: 10.3389/fmed.2025.1655210. eCollection 2025.

    PMID: 42007199BACKGROUND
  • Candal RE, Kalakoti P, Briones B, Sugar JG, Lairmore TC, White RK, Samra NS. Healthcare Provider's Preferences on Open Versus Restricted Visiting Hours in Surgical Intensive Care Unit. Cureus. 2024 Sep 21;16(9):e69871. doi: 10.7759/cureus.69871. eCollection 2024 Sep.

    PMID: 39435240BACKGROUND
  • Berti D, Ferdinande P, Moons P. Beliefs and attitudes of intensive care nurses toward visits and open visiting policy. Intensive Care Med. 2007 Jun;33(6):1060-5. doi: 10.1007/s00134-007-0599-x. Epub 2007 Mar 24.

    PMID: 17384930BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: prospective pre/ post study with repeated measures
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 21, 2026

Study Start

September 29, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share

a formal request needs to be sent by mail to the PI + juridischedienst@uzbrussel.be The legal department of UZ Brussel needs to be involved in drafting the Data Sharing Agreement. Additionally, specifications on the data granularity, timing of sharing, restricted availability, proposed transfer-medium, will be defined upfront.

Shared Documents
STUDY PROTOCOL
Time Frame
01/2028
Access Criteria
a formal request needs to be sent by mail to the PI + juridischedienst@uzbrussel.be The legal department of UZ Brussel needs to be involved in drafting the Data Sharing Agreement. Additionally, specifications on the data granularity, timing of sharing, restricted availability, proposed transfer-medium, will be defined upfront.

Locations