Waitlist-controlled Trial of a Psychological Education Program for Nurses

Psychological Stress Clinical Trial

Official title:

Waitlist-controlled Trial of a Psychological Education Program for Nurses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01593683
• Other study ID #: MGH 2011-P-002799
• Status: Active, not recruiting
• Phase: N/A
• First received: May 4, 2012
• Last updated: July 9, 2013
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test a brief education program for oncology nurses, to enhance their skills for managing psychosocial stressors associated with providing direct patient care. The investigators will explore efficacy of the intervention for reducing psychological stress and medical errors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have RN degree

• Must be employed as an oncology nurse in an inpatient, infusion, or ambulatory care unit

Exclusion Criteria:

• Participation in earlier pilot trial of the intervention

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Psychological education program for nurses
Approximately 4 weekly one-hour group sessions led by study clinicians and 1 optional individual session with a single study clinician.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in psychological stress as measured by the Perceived Stress Scale and the Maslach Burnout Inventory		At approximately 16 and 32 weeks post-baseline	No
Secondary	Change in from baseline in medical errors as measured by the Medical Errors Questionnaire		At approximately 16 and 32 weeks post-baseline	No