NCT03458013

Psychosocial Outcomes in Hand Therapy

Exploring Psychosocial Outcomes in Hand Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Rationale: there is a need for psychosocial symptom management in hand therapy which has been understudied. Mindfulness-based interventions are used to address psychosocial symptoms in other settings such as chronic injury but have yet to be implemented or explored for patients in acute outpatient rehabilitation. Intervention: a supplemental mindfulness-based intervention (MBI) will be provided to the experimental group while the control group will receive standard care. The MBI will begin with an explanation of the purpose of a mindfulness, how mindfulness relates to hand therapy, and lead to a 20-minute guided meditation using an audio recording. Objectives: to establish the feasibility of providing a MBI in hand therapy and evaluate preliminary effects of the MBI on patients' stress, anxiety, and depression. Population: adult patients at an outpatient hand therapy clinic in the Los Angeles area who have received a traumatic injury (e.g., tendon laceration, compound fracture, finger amputation). Methodology: the study will use a mixed-methods, non-randomized, 2-group, comparative trial design with 40 participants in total. Quantitative data on psychosocial outcomes, including salivary cortisol, will be collected once a week for 4 weeks while patients are attending hand therapy and qualitative interviews will be conducted at the end of the study. Study arms: the experimental group (n = 20) will receive the MBI just before regularly scheduled standard care visits. The control group (n = 20) will receive only standard care. Outcomes: this pilot study will be used to inform a future fully powered trial on mindfulness-based interventions in hand therapy. Feasibility and preliminary psychosocial effects of MBIs will be evaluated and used to inform future work. Analysis: (1) A repeated measures ANOVA for intervention group, time, and time by intervention group effects on the psychosocial outcomes (i.e., Cortisol, Anxiety, Depression, and Pain Catastrophizing). (2) A descriptive qualitative process will be used to analyze themes in participant interview responses.

Conditions

• Hand Injuries

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Meditation	Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each.

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-01-22
• Completion: 2020-01-22
• First posted: 2018-03-08
• Last updated: 2020-11-03

Locations

2 sites across 1 country: United States