Improve Mental Health and Emotional Labor Among Nurses Who Care the End-of-life Patients
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
1 other identifier
interventional
100
1 country
2
Brief Summary
CBT: cognitive behavioural therapy MBT: mindfulness-based therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedSeptember 15, 2022
September 1, 2022
8 months
September 12, 2022
September 13, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Anxiety
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
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
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
Study Arms (2)
cognitive behavioural therapy
EXPERIMENTALmindfulness-based therapy
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huichao Zhanglead
Study Sites (2)
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210001, China
Wu Ye
Nanjing, Jiangsu, 210001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 12, 2022
First Posted
September 15, 2022
Study Start
May 1, 2022
Primary Completion
December 30, 2022
Study Completion
January 1, 2023
Last Updated
September 15, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share