NCT06238141

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2024

Completed
Last Updated

March 25, 2026

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

January 24, 2024

Last Update Submit

March 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (3)

  • 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

    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

    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

    At baseline, post-intervention at Week 9, 11-week and 13-week follow-ups.

Study Arms (2)

intervention group

EXPERIMENTAL
Other: Expressive writing

control group

SHAM COMPARATOR
Other: Neutral writing

Interventions

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).

intervention 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.

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changzhi Medical College

Changzhi, Shanxi, China

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • XUAN JI

    Changzhi Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
This study is single-blinded. The intervention trainer will not be blinded because a single researcher conducts the study. In order to minimize experimenter bias, outcome assessments will be conducted through an online questionnaire survey platform (Wenjuanxing), with the trainer distributing the same link to all participants. During data collection, only acronyms of the questionnaires will be used to avoid self-fulfilling expectations. Participants will be informed during the recruitment phase that the study aims to explore the effect of writing on the internship experience and feelings only. Assignment to the intervention or control group will remain undisclosed to participants until the end of the 4-week follow-up. Participants could unblind themselves by exiting the study and requesting debrief information.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 2, 2024

Study Start

July 15, 2024

Primary Completion

October 13, 2024

Study Completion

October 13, 2024

Last Updated

March 25, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Individual deidentified participant data underlying the results reported in this article, including demographic information and outcome measures, will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available beginning one month after manuscript acceptance and will remain accessible for three years thereafter.
Access Criteria
The data will be shared with researchers who submit a methodologically sound research proposal for non-commercial academic purposes. Requests should be submitted to the corresponding author, and approved requestors will be required to sign a data use agreement prior to data access.

Locations