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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05541523
Other study ID # SJCX22_0702
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date January 1, 2023

Study information

Verified date September 2022
Source Nanjing University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

CBT: cognitive behavioural therapy MBT: mindfulness-based therapy


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?


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 1, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive behavioural 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.
mindfulness-based 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.

Locations

Country Name City State
China the First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China Wu Ye Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Huichao Zhang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 a 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
Primary 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
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