- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06238141
Expressive Writing on Stress-Related and Work-Related Outcomes Among Chinese Nursing Interns
Effects of Expressive Writing on Stress-Related and Work-Related Outcomes Among Chinese Nursing Interns: a Randomized Controlled Trial
The goal of this interventional study is to assess the effects of an intervention on stress-related and work-related outcomes among Chinese nursing interns. The main questions it aims to answer are:
- Does expressive writing reduce clinical practice stress and improve coping strategies in nursing interns?
- Does expressive writing increase work engagement and perceived professional benefit among nursing interns?
Participants in the intervention group and control group will perform expressive writing and neutral writing, respectively, based on different given instructions. In both groups, writing will last for 10-15 minutes each time, twice a week, for nine weeks.
Researchers will compare the outcomes of the two groups to see if there are differences between clinical practice stress, coping strategies, work engagement, and perceived professional benefit.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanxi
-
Changzhi, Shanxi, China
- Changzhi Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergraduate nursing interns in their first clinical internship (had no prior clinical practice experience)
- Be willing to fill in questionnaires and write according to the assigned writing prompts
- Never participated in writing therapy or stress management intervention programs
Exclusion Criteria:
- Refusal to participate
- Severe current psychological conditions
- Undergoing any form of psychotherapy
- With a habit of keeping diaries
Withdrawal criteria:
- Termination of internship for whatever reason
- Not submit writing materials twice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
|
According to the writing prompts, online expressive writing focuses on stressful events and will be conducted twice a week (every Monday and Thursday) for 10-15 minutes each time, lasting for nine weeks. Writing prompts are developed based on Emotional Processing Theory (EPT) and Cognitive Adaptation Theory (CAT). |
|
Sham Comparator: control group
|
According to the writing prompts, online neutral writing focuses on immediate surroundings and will be conducted twice a week (every Monday and Thursday) for 15 minutes each time, lasting for ten weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change from Baseline in Clinical Practice Stress Scores on the Stress Rating Scale for Nursing Interns in Practice at 9 Weeks, 11 Weeks and 13 Weeks
Time Frame: At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
The scale consists of 6 dimensions and 37 entries, including the nature of work, workload, preparation for an internship, interpersonal relationships, work support, and learning and work impulse.
The scale rates on a 4-point Likert scale, with no stress, mild stress, moderate stress, and severe stress, assigned a score of 0, 1, 2, and 3, respectively, and the higher the score, the greater the stress.
|
At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Change from Baseline in Positive and Negative Coping Style Scores on the Brief Coping Style Scale at 9 Weeks, 11 Weeks and 13 Weeks
Time Frame: At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
The scale consists of two dimensions, positive and negative coping, with 20 entries.
A 4-point Likert scale is used, with 1-4 indicating "not used" to "often used".
Positive coping has 12 entries, and negative coping has 8 entries, with higher scores indicating more frequent use of coping strategies.
|
At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
|
Mean Change from Baseline in Work Engagement Scores on the Utrecht Work Engagement Scale at 9 Weeks, 11 Weeks and 13 Weeks
Time Frame: At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
The scale consists of 3 dimensions: vitality, dedication, and concentration, comprising 15 entries.
A 7-point Likert scale is used, with scores ranging from 0-6 for "never," "almost never," "rarely," "sometimes," "often," "frequently," and "always."
The total score is the sum of the scores of each entry.
An average entry score of 4 or more is defined as a high level of work engagement, 2-4 as a moderate level, and less than 2 as a low level of work engagement.
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At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
|
Mean Change from Baseline in Perceived Professional Benefits Scores on the Perceived Professional Benefits Scale at 9 Weeks, 11 Weeks and 13 Weeks
Time Frame: At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
The scale consists of 7 items of positive career sense, 6 items of good nurse-patient relationship, 6 items of sense of belonging to the team, 8 items of self-growth, and 6 items of identification with friends and relatives, totaling 33 items in 5 dimensions, and each item is scored 1 to 5 on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree.
The higher the score, the stronger the perceived professional benefit.
|
At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: XUAN JI, Changzhi Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RT2023047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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