ISRCTN ISRCTN10480033
DOI https://doi.org/10.1186/ISRCTN10480033
Submission date
14/06/2023
Registration date
14/06/2023
Last edited
11/06/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Many patients experience stress during hospitalization. In these hospital settings, the impact of the design of inpatient rooms on patients is still not well understood. The aim of this study is to assess the effects of different design principles on patients.

Who can participate?
Patients who were hospitalized for at least one night in the Netherlands

What does the study involve?
The patients are randomly allocated to one of the four conditions in an online randomized trial using the survey program Qualtrics. Patients are exposed to a video, pictures, floor plan, and a detailed description of the facilities in the room.

What are the possible benefits and risks of participating?
None.

Where is the study run from?
Hanze University of Applied Sciences, Groningen, The Netherlands

When is the study starting and how long is it expected to run for?
March 2021 to August 2022

Who is funding the study?
This study was funded by the Delta Prize (Deltapremie) number PR.01.2. (The Netherlands)

Who is the main contact?
Dr E. Zijlstra
e.zijlstra@pl.hanze.nl

Contact information

Dr Emma Zijlstra
Scientific

Zernikeplein 7
Groningen
9747 AS
Netherlands

ORCiD logoORCID ID 0000-0001-6731-4299
Phone +31 50-5952672
Email e.zijlstra@pl.hanze.nl

Study information

Study designMulti-arm parallel-group randomized trial
Primary study designInterventional
Secondary study designMulti-arm parallel-group randomized trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleThe impact of the hospital inpatient room on patients' stress
Study objectivesEvidence-based design, feng shui design, and golden ratio design will reduce patient's anxiety during hospitalization
Ethics approval(s)Ethics approval not required
Ethics approval additional informationAccording to the Dutch Law for medical research involving human subjects (WMO), a waiver for ethical assessment was provided by the Medical Ethical Committee of the Medical University of Groningen (METc 2022/259). The study was conducted according to the declaration of Helsinki.
Health condition(s) or problem(s) studiedDesign hospital room
InterventionIn an online multi-arm parallel-group randomized trial participants were randomly assigned (1:1:1:1) to one of four conditions, namely golden ratio condition, feng shui condition, evidence-based design condition, or the control condition.

Participants were exposed to a 2-minute video of the patient room, two pictures of the patient room, two pictures of the bathroom, the 3D floorplan, and a detailed description of the facilities in the rooms.

Participants were automatically randomized by the online survey program to one of the four intervention groups (Qualtrics).
Intervention typeBehavioural
Primary outcome measureAnxiety is measuring using the STAI-6 scale after viewing the video
Secondary outcome measures1. Sense of coontrol, social support, and positive distraction is measured using the SHEDS scale after viewing the video
2. Pleasantness of the room was measured using a 10-point bipolar scale after viewing the video
Overall study start date01/03/2021
Completion date22/08/2022

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit100 Years
SexBoth
Target number of participants700
Total final enrolment740
Key inclusion criteria1. Aged 18 years or older
2. Hospitalized in their lives for at least one night in the Netherlands
Key exclusion criteriaHospitalized for the last time at a (1) psychiatric ward, (2), at a rehabilitation clinic, or (3) for the birth of their child
Date of first enrolment24/06/2022
Date of final enrolment30/06/2022

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Hanze University of Applied Sciences
Zernikeplein 7
Groningen
9704 AA
Netherlands

Sponsor information

Hanze University of Applied Sciences
University/education

Zernikplein 7
Groningen
9747 AS
Netherlands

Phone +31 50-5955555
Email info@org.hanze.nl
Website https://www.hanze.nl/eng
ROR logo "ROR" https://ror.org/00xqtxw43

Funders

Funder type

Government

Nationaal Regieorgaan Praktijkgericht Onderzoek SIA
Government organisation / National government
Alternative name(s)
Nationaal Regieorgaan Praktijkgericht Onderzoek, National Board of Practice-Oriented Research SIA, National Board of Practice-Oriented Research, Regieorgaan SIA, NRPO-SIA
Location
Netherlands

Results and Publications

Intention to publish date01/07/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planAll data will be available with publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 05/06/2024 11/06/2024 Yes No

Editorial Notes

11/06/2024: Publication reference added.
14/06/2023: Trial's existence confirmed by Medical University of Groningen.