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Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder

Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder (PTSD) in Family Members.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03846323
Acronym
OPEN-UNIT
Enrollment
1289
Registered
2019-02-19
Start date
2009-04-18
Completion date
2018-02-12
Last updated
2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD in Family Members of ICU Patients

Keywords

Posttraumatic stress disorder (PTSD), ICU, visiting hours policies

Brief summary

This was a cluster randomized study of an ICU level intervention to reduce high risk of post-traumatic stress disorder (PTSD) in family members of ICU patients. Participating ICUs had restrictive visiting policies (i.e., \<6 hours/day) before randomization. After an observational period and a washout period, participating ICUs were randomized either to maintain their visiting policies or to liberalize their visiting policies (24 hours a day, 7 days a week.)

Detailed description

Family members of ICU patients are particularly exposed to anxiety, depressive, acute stress disorder, and posttraumatic stress disorder symptoms (PTSD). It is currently unknown what type of interventions/ strategies to cope with postintensive care syndrome family would produce the best improvement. Experts suggest that symptoms in family members are potentially amenable to intervention by ICU staff. One intervention to reduce PTSD could be a liberalization of the visiting hours. However, restrictions on visiting hours in the intensive care unit (ICU) are usually adopted worldwide.

Interventions

OTHERVisiting policies: 24 hours a day, 7 days a week
OTHERRestriction of visiting policies < 6 hours

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

: Patient and family member \> 18 years or older, * mechanical ventilation expected for more than 48 h and inclusion between day 3 and 5 from the beginning of mechanical ventilation, * patient having a family member speaking and understanding French, and with the ability to visit his/her relative during the ICU stay, * patient and his/her relative consenting to participate in the study, or obtention of family consent in case of patient incompetency

Exclusion criteria

: \- Patient without family available or family not speaking or understanding French

Design outcomes

Primary

MeasureTime frameDescription
Symptoms related to posttraumatic stress disorder (PTSD)at day-90 from patient's ICU dischargeImpact event scale (IES). The Impact of Event scale (IES), which assesses symptoms related to post-traumatic stress disorder (PTSD); scores range from 0 (no PTSD-related symptoms) to 75 (severe PTSD-related symptoms).

Secondary

MeasureTime frameDescription
Family member's needsAt inclusionCritical Care Family Needs Inventory (CCFNI) Family needs and satisfaction was measured by a modified version of the Critical Care Family Needs Inventory (CCFNI). The satisfaction score was calculated as the sum of the scores on all items; the smallest possible score was 0 (extreme dissatisfaction) and the highest possible score was 14 (extreme satisfaction).
Family members' symptoms of anxiety and depressionAt inclusion and Day-90 from patient's ICU dischargeHospital and Anxiety Depression Scale (HADS) The Hospital and Anxiety and Depression Scale (HADS), subscale scores range from 0 (no distress) to 21 (severe distress), HADS subscales scores 5Anxiety and Depression) above 8 were considered to indicate clinically significant symptoms of anxiety or depression.
Beliefs and attitudes of healthcare workers toward visiting hours120 daysBeliefs and Attitudes toward Visitation in ICU Questionnaire (BAVIQ). Beliefs and attitudes of ICU staff members were recorded at the beginning of period 1 (observation period) and at the end of period 2 (intervention period) using a questionnaire named the Beliefs and Attitudes toward Visitation in ICU Questionnaire (BAVIQ). The Beliefs questionnaire contains both positively and negatively formulated questions. To calculate an overall score for nurses 'beliefs, we recoded the responses on the negatively formulated questions. Subsequently, we computed the average score over all the belief items. A score of zero corresponded with beliefs that are strongly opposed to open visitation and a score of 4 corresponded with beliefs that are strongly in favor of open visitation.
Patients' symptoms of anxiety and depressionAt day-90 from patients'ICU dischargeHospital and Anxiety Depression Scale (HADS) The Hospital and Anxiety and Depression Scale (HADS), subscale scores range from 0 (no distress) to 21 (severe distress), HADS subscales scores (Anxiety and Depression) above 8 were considered to indicate clinically significant symptoms of anxiety or depression.
the proportion of patients with High risk of PTSD occurrenceAt day-90 from patients'ICU dischargeScore IES \> 30 points
the proportion of family members with High risk of PTSD occurrenceAt day-90 from patients'ICU dischargeScore IES \> 30 points

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026