Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06077578 |
| Other study ID # |
HPS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 6, 2023 |
| Est. completion date |
March 31, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
Ho Cheung William Li |
| Phone |
3943 0889 |
| Email |
williamli[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Aim This proposed study aims to investigate the perceptions, behavior, and attitudes of
healthcare professionals, previously hospitalized children, and parents of these children
toward hospital play services in the Hong Kong healthcare system. In addition, in-depth
interviews will be conducted with selected participants to investigate their views on the
role of hospital play specialists , as well as the sustainability and development of hospital
play specialists services in Hong Kong hospitals
Study Design A mixed-methods (quantitative and qualitative) approach will be used to collect
data. The study will be divided into two phases. In Phase I, a cross-sectional study, using a
structured questionnaire, will be conducted on healthcare professionals in the pediatric
units of six acute care public hospitals from different regions of Hong Kong. In Phase II,
in-depth semi-structured interviews will be conducted with randomly selected healthcare
professionals who have participated in the Phase I study. In addition, the investigators will
collect feedback and comments from previously hospitalized children and their parents.
Description:
i) Phase I study A retrospective cross-sectional questionnaire will be administered to the
healthcare professionals who work in the abovementioned public hospitals. A convenience
sample of 150 healthcare professionals will be recruited. In addition, the investigators will
contact professional pediatric organizations, such as the Hong Kong Pediatric Society and
Hong Kong College of Pediatric Nursing to help invite healthcare professionals to participate
in this research.
A structured questionnaire has been developed based on existing international and/or local
literature. The information gathered will include perceptions of and attitudes toward
hospital play, the feasibility and usefulness of hospital play, understanding the roles and
responsibilities of hospital play specialists , perceptions of collaborating with hospital
play specialists , and perceptions of the need for hospital play services in Hong Kong
hospital settings. In addition, demographic information, including age, gender, occupation,
and years of experience in taking care of hospitalized children, will be documented.
Data Analysis for the Phase I Study Data analysis will be performed using SPSS Statistics for
Windows, V.26.0 (IBM). Continuous variables with normal distribution will be presented as the
mean and standard deviation, and those with non-normal distribution will be presented as the
median. Categorical variables will be presented as the frequency and proportion.
ii) Phase II Study A semi-structured interview will be conducted with randomly selected
healthcare professionals who have participated in the Phase I study. A semi-structured
interview guide will be developed by the research team, which includes a professor with
extensive knowledge of and experience in conducting both quantitative and qualitative
research related to pediatric patients and hospital play activities and a team of experts
working in Playright with extensive experience in conducting hospital play interventions for
hospitalized children. The interview guide will be further assessed for its relevancy and
wording appropriateness by two advanced practice nurses working in Children's Hospital with
extensive experience in providing care for hospitalized children.
A purposive sample of 20 healthcare professionals randomly selected from the Phase I study
and 10 children previously admitted to hospitals, and their parents, will be recruited for
the interviews. However, the actual sample size will depend on data saturation. A one-to-one
audiotaped semi-structured in-depth interview will then be conducted with each participant
until data saturation is achieved. Each interview will last approximately 20 to 30 minutes.
During each interview, a research assistant will act as the interviewer to facilitate the
informants to freely express their feelings, thoughts, and ideas. Another research assistant
will act as an observer to document all non-verbal cues of the informants.
Data Analysis for the Phase II Study After conducting the interviews, the recordings will be
fully transcribed, verbatim, in Cantonese to capture the nuances of expression unique to the
dialect, and selected quotations relevant to the themes will subsequently be translated into
English. During the coding process, two researchers will be responsible for analyzing the
narratives. The analyses will begin with an intensive examination of the transcripts to
search for general constructs and themes. Special attention will be given to constructs that
diverge from the major topics framed by the guiding questions. The transcripts will first be
coded using the open coding method. Details in the interview conversations will then be
closely examined to extract a large number of initial categories. As the number of codes
increases, some closely related codes will be merged, resulting in a smaller, more manageable
set of codes. Selective coding will then be adopted to code the transcripts using the
established categories. To facilitate the data analysis process, meetings will be held to
discuss emergent themes. During the coding process, any inconsistencies in the interpretation
of quotations or the assignment of codes will be resolved through discussions with the
research team members. Finally, a complete set of codes will be generated to facilitate
comparisons and the development of themes and categories. To achieve a more coherent and
logical structure, the themes and categories will be modified by breaking down complicated
concepts, merging similar ones, and rearranging certain themes and categories based on their
relationships. The analyses will be performed using NVivo Version 9 (QSR International Pty
Ltd., 2010).
To ensure data credibility, the interviewer will first ask iterative questions and use probes
during the interviews. Second, debriefing sessions will be held between the research
assistants and the principal investigator after every five interviews. Modifications will be
made by the principal investigator according to the developing ideas and interpretations.
Third, data analysis will be performed by two researchers independently, and field notes will
be taken into account during the analysis. Regular research team meetings will be held to
resolve any disagreements that may arise. The informants will also be invited to review the
transcripts and clarify the meaning of their statements, if required. To increase the
transferability of the findings, the study will be conducted in acute care hospitals from
different regions in Hong Kong. Purposive sampling will be adopted to maximize sample
variation, which will help the investigators to obtain a representative group of informants
for the interviews. To ensure the confirmability and dependability of the findings, an audit
trail will be maintained by another experienced researcher who is not part of this research
team. She will review a collection of documents to attest to the interpretations of the
researchers.
