NCT07105774

Brief Summary

The aim of this clinical trial is to find out whether a stress inoculation program can reduce occupational stress in new psychiatric nurses. The main question it aimed to answer was: Does a stress inoculation training program improve participants' occupational stress, coping styles, and sleep quality? The researchers compared the stress inoculation training to a conventional training control to see if the stress inoculation training reduced occupational stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

July 27, 2025

Last Update Submit

August 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Job stress scale for newly-graduated nurses (JSSNGN)

    Job stress scale for newly-graduated nurses (JSSNGN) is used to measure the level of occupational stress among new nurses. The scale consists of 4 dimensions and 24 items, including tasks in general care (9 items), tasks in critical care (4 items), interpersonal relationships (5 items), and leadership and management (6 items), and is based on a Likert's 5-point scale, ranging from "not stressful at all" to "extremely stressful", with Cronbach's α=0.93. JSSNGN was used to measure the level of occupational stress of new psychiatric nurses in this study. The scale has a total score range of 24 to 120, with higher scores representing greater occupational stress.

    From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (2)

  • Simplified Coping Style Questionnaire (SCSQ)

    From enrollment to the end of treatment at 12 weeks

  • Pittsburgh sleep quality index (PSQI)

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

The control group received routine training

PLACEBO COMPARATOR

routine theoretical knowledge training and clinical practice training.

Behavioral: routine training

The intervention group received the SIT program

EXPERIMENTAL

Establishment of online training groups, Establishment of stress reduction workshops and peer support groups, Organization of recreational activities and games for groups, ntroducing the concept, the program's curriculum, and process organization, Cognitive restructuring training, Relaxation training, Setting up virtual stressful situations and conducting stress resilience exercises, Self-reinforcement and consolidation, Applying competencies to solve practical problems, Recall and consolidation of course content

Behavioral: stress inoculation training program

Interventions

The intervention group received the SIT program for 12 weeks. From 1st-2nd weeks, participants were admitted to an online training group set up via DingTalk, attending an offline stress reduction workshop were grouped into groups of 5-6, with games and small activities to promote group bonding. Psychiatric-psychological nurse specialist introduced the participants to the concept of SIT, the curriculum, and asked them to describe their initial knowledge and understanding of SIT. In addition, through cognitive restructuring training, the participants were made to review their work experience, understand the work stress and psychological pain they faced, and correctly recognize the role of cognition and emotion in causing and maintaining stress. From 3rd-6th weeks, participants were portrayed and discussed through videos and images, exploring personal, organizational and environmental stressors for new psychiatric nurses. Psychiatrists led relaxation exercises (e.g. positive thinking, med

Also known as: stress inoculation training
The intervention group received the SIT program

The control group received training in accordance with the "New Entry Nurse Training Syllabus (Trial)", which included routine theoretical knowledge training and clinical practice training.

The control group received routine training

Eligibility Criteria

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

You may qualify if:

  • obtained nurse practitioner's license;
  • nurses who were newly employed within the last three years and have been in their position for one month or longer;
  • directly interacting with patients with mental illnesses in daily work;
  • obtained informed consent to participate voluntarily in this study.

You may not qualify if:

  • non-fresh graduates;
  • these taking vacations, refresher courses during the study period;
  • were breastfeeding or pregnant;
  • had attended a similar stress intervention training (e.g., Positive Thinking Stress Reduction training, etc.) within the past year;
  • new major non-work stressors (e.g., death of a close family member, divorce, exposure to a major natural disaster, etc.) within the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huzhou University

Huzhou, Zhejiang, 313000, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Nurse

Study Record Dates

First Submitted

July 27, 2025

First Posted

August 6, 2025

Study Start

September 7, 2024

Primary Completion

January 30, 2025

Study Completion

February 3, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Locations