Dignity Therapy for Terminally Ill Patients: A Randomized Controlled Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Death
- Dignity
- Emotional Stress
- Psychological Distress
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Sample size assessment: A recent meta-analysis showed that dignity interventions reach on average effect sizes of -1.01 on emotional distress (Ho and Shin, 2014). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 26 participants to detect effect sizes of 1.0...
Sample size assessment: A recent meta-analysis showed that dignity interventions reach on average effect sizes of -1.01 on emotional distress (Ho and Shin, 2014). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 26 participants to detect effect sizes of 1.01 and higher. Plan for missing data: Occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced. Statistical analysis plan: We conducted a 2 (group) X 3 (time [pre-treatment vs. post-treatment vs follow-up]) repeated measures multivariate analysis of variance (MANOVA) for a set of variables
Tracking Information
- NCT #
- NCT04256239
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Luca Iani, PhD European University of Rome
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