ClinicalTrials.gg
Enrolling by invitationNCT07887009RUIMIZUpdated Oct 21, 2026

Attitudes, Experience and Adaptation to Family Presence in the ICU

An interventional study of questionnaire in ICU Staff Attitudes Toward Family Presence, ICU Staff Experience of Family Presence and Adaptation to Extended Family Presence in the ICU, sponsored by Universitair Ziekenhuis Brussel. Enrolling by invitation at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Health services research

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • ICU Staff Attitudes Toward Family Presence
  • ICU Staff Experience of Family Presence
  • Adaptation to Extended Family Presence in the ICU
  • Association Between Stress Sensitivity and Attitudes Toward Family Presence

Keywords

  • Intensive Care Unit
  • ICU staff
  • family presence
  • visiting policy
  • staff attitudes
  • staff experience
  • adaptation
  • family-centered care
  • BAVIQ
  • stress sensitivity
  • IPIP-NEO
03

In context

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 374 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • healthcare professionals in training
  • healthcare professionals working in pediatric intensive care members of the research team
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    questionnaire on attitudes and validation of family participation on ICU

    questionnaire

    Other: questionnaire

Interventions

  • Otherquestionnaire

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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

    This is measured using a shift questionnaire assessed after indiviual work shifts. Rated on a 0-10 scale : * percieved family presence during the shift * amount of direct contact with the family members * perceived burden related to family presence * perceived support or positive contribution of family presence. Open-ended comments on factors influencing burden or support. Time points: T1 = implementation time point, during the early implementation period of the extended visiting policy (less then six months).

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

07

Study locations

1 site
  • Universitair Ziekenhuis
    Brussels, 1090, Belgium
08

References and documents

Publications

  • 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. PubMed 31668437 ↗
  • 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. PubMed 41295830 ↗
  • 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. PubMed 42132067 ↗
  • 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. PubMed 42007199 ↗
  • 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. PubMed 39435240 ↗
  • 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. PubMed 17384930 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: 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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07887009
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Sep 29, 2026
Primary completion
Nov 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Oct 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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