Psychosocial Outcomes in Hand Therapy

Hand Injuries Clinical Trial

Official title:

Exploring Psychosocial Outcomes in Hand Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458013
• Other study ID #: HS-17-00935
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: January 22, 2020

Study information

• Verified date: November 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old; newly entering hand therapy, having a diagnosis of distal radius fracture, flexor tendon injury and repair, extensor tendon injury and repair, tramatic finger amputation, or other traumatic injury; established therapy plan of care lasting at least 4 weeks; able to read and with in English; with regular access to a computer.

Exclusion Criteria:

• diagnosed with a severe mental illness; currently an expert in mindfulness practices

Related Conditions & MeSH terms

• Hand Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	St. Jude Centers for Rehabilitation & Wellness	Brea	California
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Abbott Medical Devices, California Foundation for Occupational Therapy

Country where clinical trial is conducted

United States, 

References & Publications (4)

Aardal E, Holm AC. Cortisol in saliva--reference ranges and relation to cortisol in serum. Eur J Clin Chem Clin Biochem. 1995 Dec;33(12):927-32. — View Citation

Radloff, LS. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement 1(3): 385-401, 1977.

Spielberger CD, Vagg PR, Barker LR, Donham GW, Westberry LG. The factor structure of the State-Trait Anxiety Inventory. In CD Spielberger & IG Sarason (Eds.), Stress and anxiety (pp. 244-279). Washington, DC: Hemisphere; 1980.

Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4): 524 - 532, 1995.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline Salivary Cortisol Across 4 weeks	Cortisol is a bio-marker for stress (Aardal & Holm, 1995). Normal values in healthy adults are sensitive to time of day, but range from 3.5 to 27.0 nmol/l in the morning. Higher salivary cortisol levels are an indicator of higher levels of stress.	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	Change in Baseline State Anxiety Across 4 weeks	The State-Trait Anxiety Inventory: State subscale (Spielberger, Vagg, Barker, Donham, & Westberry, 1980) is scored positively (higher scores equate to higher anxiety) with a minimum score of 20 and a maximum score of 80. Normative data for this scale indicates that a cut point score of 40 and above is considered clinically relevant.	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	Change in Baseline Depression Across 4 weeks	Center for Epidemiologic Studies - Depression scale (CES-D; Radloff, 1977), is a 20-item depression scale that is positively scored (higher scores equate to higher depression) ranging from 0 to 60. It is intended for use with the general population with a conservative off is score being greater than 16.	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks
Secondary	Change in Baseline Pain Catastrophizing Baseline Across 4 weeks	Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) measures an individual's exaggerated negative psychological response to pain or the anticipation of pain. The scale is scored positively across 13 total items composing 3 subscales: rumination, magnification, and helplessness. These subscales are added together to get the total score from 0 to 52. The middle 50% of scores on this scale fall between 10 and 30 points.	Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks