- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541523
Improve Mental Health and Emotional Labor Among Nurses Who Care the End-of-life Patients
September 13, 2022 updated by: Huichao Zhang
Does Cognitive Behavioural Therapy or Mindfulness-based Therapy Improve Mental Health and Emotional Labor Among Nurses Who Care the End-of-life Patients? A Randomized Controlled Trial
CBT: cognitive behavioural therapy MBT: mindfulness-based therapy
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Nurses caring for terminally ill patients suffer from negative emotions and emotional labor, which may lead to a decline in the quality of end-of-life care.
CBT and MBT are currently two commonly used psychological methods.
They can be effective in improving bad mood.
However, to the best of our knowledge, no investigators have used CBT and MBT among nurses caring for terminally ill patients.
Could CBT and MBT be effective in alleviating the psychological distress of these nurses?
Which psychological method is more effective?
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210001
- Recruiting
- The First Affiliated Hospital of Nanjing Medical University
-
Contact:
- Yuxi Zhang, master
- Phone Number: 18851009369
- Email: 806867157@qq.com
-
Nanjing, Jiangsu, China, 210001
- Recruiting
- Wu Ye
-
Contact:
- Yuxi Zhang, master
- Phone Number: 18851009369
- Email: 806867157@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (1) Eligible participants were the nurses who nursing patients with stage IV cancer or other incurable diseases;
- (2) agree to participate in this research;
- (3) no history of mental illness.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mindfulness-based therapy
|
The three therapists in the cognitive behavioural group therapy condition were two students of master's degree of nursing with formal education in cognitive therapy and one psychological specialist nurse working in a palliative care unit.
There was no evidence of significant deviation from the protocol.
|
Experimental: cognitive behavioural therapy
|
The two therapists in the mindfulness-based stress reduction condition were one clinical psychologist and one student of master's degree of nursing with formal education in mindfulness.Both interventions were manualized.
To assure adherence to the study protocol meetings between the therapists and the researchers were organized regularly and the therapists detailed the content of each group session in clinical records which were frequently monitored by a research assistant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: up to 8 weeks
|
The Hamilton Anxiety Rating Scale (HAM-A), developed by Hamilton in 1959,26 was used in this study to assess the anxiety level of the patients.
The HAM-A contains 14 items, each scored on a 5-point scale (0, asymptomatic; 1, mild symptoms; 2, moderate symptoms; 3, severe symptoms; 4, extremely severe symptoms).
The total sum score, ranging from 0 to 56, can be classified into four levels: 0, no anxiety symptoms; 1-17, mild anxiety; 18-24, moderate anxiety; 25-56, severe anxiety.
|
up to 8 weeks
|
Emotional labor
Time Frame: up to 8 weeks
|
Chinese version scale of emotional labor(C-ELS).
Permission to use the Chinese version of the instruments was obtained.
To the best of our knowledge, this is the first time these questionnaires are used in palliative care programs in China, using a five-point Likert type scale ("1" = "strongly disagree," "7" = "strongly agree").
The scale divided emotional labor into four part surface acting, deep acting, expression of naturally felt emotions and emotion termination.
The Cronbach's α of surface acting, deep acting, expression of naturally felt emotions and emotion termination were 0.714, 0.743, 0.846, 0.758, respectively.
|
up to 8 weeks
|
Self-Efficacy
Time Frame: up to 8 weeks
|
Occupational Coping Self-Efficacy Scale for Nurses ( OCSE-N, Occupational Coping Self-Efficacy Scale for Nurses ), a total of 9 items, using Likert 5-level scoring method, 1 means ' can not easily deal with ' to 5 means ' can easily deal with ', the total score range of 9 to 45 points, the higher the score, the higher the occupational coping self-efficacy of nurses.
|
up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
January 1, 2023
Study Registration Dates
First Submitted
September 12, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
September 15, 2022
Last Update Submitted That Met QC Criteria
September 13, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJCX22_0702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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