NurseNCT07105774
The Effects of Stress Inoculation Training Program on Occupational Stress Level, Coping Style, and Sleep Quality in New Psychiatric Nurses.
A study testing stress inoculation training program and routine training in people with Nurse and Psychiatric, run by Huzhou University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse, Psychiatric, Stress Inoculation Training
- What is being tested?
- stress inoculation training program and routine training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2024to 3 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Stress Inoculation Training Program on Occupational Stress Level, Coping Style, and Sleep Quality in New Psychiatric Nurses：A Randomized Controlled Trial.
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.
- Conditions
- Nurse, Psychiatric, Stress Inoculation Training
- Being tested
- stress inoculation training program, routine training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress inoculation training programBehavioural
Also called stress inoculation training
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
routine trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| The control group received routine training | Placebo comparator | routine theoretical knowledge training and clinical practice training. Receives: 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 Receives: Behavioral: stress inoculation training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
Simplified Coping Style Questionnaire (SCSQ)
Simplified coping style questionnaire (SCSQ) is designed to measure an individual's coping style in the face of a stressful event. Two subscales are active coping (problem-focused, SCSQ-A) and passive coping (emotion-focused, SCSQ-P) with items 1to12 for active coping strategies (problem-focused, SCSQ-A) and items 13 to 20 for passive coping strategies (emotion-focused, SCSQ-P). Each item uses a 4-point Likert's scale ranging from 0 to 3, from "not used" to "use frequently", with Cronbach's α=0.80 and correlations of test-retest reliability of 0.89. SCSQ was used to measure the coping styles (SCSQ-A and SCSQ-P respectively) of new psychiatric nurses when faced with occupational stress in this study, with higher scores indicating more frequent use of the coping style.
Measured: From enrollment to the end of treatment at 12 weeks
Pittsburgh sleep quality index (PSQI)
Pittsburgh sleep quality index (PSQI) is used to measure the quality of an individual's sleep in the last 1 month. The scale consists of 19 self-assessed and 5 other-assessed items, of which the 19th self-assessed and 5 other-assessed items are not involved in scoring. The 18 self-assessed entries involved in scoring can be categorized into 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each of which is scored on a 4-point scale from 0 to 3, and the cumulative score for each dimension is the total PSQI score, with a Cronbach's α = 0.85. PSQI was used to measure the sleep quality of the new psychiatric nurses in this study, with a total score of 0 to 21 points, with higher scores representing poorer sleep quality.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start7 Sep 2024
- Primary completion30 Jan 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NurseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TianLe Xiang, Huzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105774
- Sponsor's protocol ID
- 202401-37
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Stress Inoculation Training Program on Occupational Stress Level, Coping Style, and Sleep Quality in New Psychiatric Nurses：A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07105774
- Acronym / sponsor ID
- 202401-37
- Conditions
- Nurse, Psychiatric, Stress Inoculation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Huzhou UniversityUniversity, hospital or other
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group received routine training | Placebo comparator | Behavioral: routine trainingroutine theoretical knowledge training and clinical practice training. |
| The intervention group received the SIT program | Experimental | Behavioral: stress inoculation training programEstablishment 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress inoculation training programAlso: stress inoculation trainingThe 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 | Behavioural | The intervention group received the SIT program |
| routine trainingThe control group received training in accordance with the "New Entry Nurse Training Syllabus (Trial)", which included routine theoretical knowledge training and clinical practice training. | Behavioural | The control group received routine training |
Primary outcome
Job stress scale for newly-graduated nurses (JSSNGN)
Time frame: From enrollment to the end of treatment at 12 weeks
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.
2 secondary outcomes
Simplified Coping Style Questionnaire (SCSQ)
Time frame: From enrollment to the end of treatment at 12 weeks
Pittsburgh sleep quality index (PSQI)
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress inoculation training program and routine training in people with Nurse and Psychiatric, run by Huzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Job stress scale for newly-graduated nurses (JSSNGN) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.