Interactive Hand-grip Strength Game in Critically Illness Patients

Study Overview
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Brief Summary
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Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigators aim to design an interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care.

Detailed Description
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Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigaters aim to design a interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care. This will be a two-arm, parallel randomized controlled trial which randomly assign patients into the game group and usual care group.

Official Title
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Effects of Interactive Hand-grip Strength Game in Critically Illness Patients: A Randomized Controlled Trial

Conditions
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Critical Illness

Intervention / Treatment
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* Other: Hand-grip Strength Game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 20 years Having clear consciousness Independently able to mobilize to complete the intervention and communicate in Chinese Richmond Agitation-Sedation Scale (RASS) 24 between +1 to -1 if using sedatives Exclusion Criteria: Suspect neurological deficits Neuromuscular disease Orthopedic injuries with contraindications to mobilize

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand-grip Strength Game<br>Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days. | Other: Hand-grip Strength Game<br>* Interactive Handgrip Strength Game for ICU patients receiving the game and to assess the impact on psychological.<br>|
| No Intervention: routine care<br>The control group will not involve hand-grip strength game at night. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on anxiety | Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 of anxiety has 7 items of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score>7 is associated with anxiety. The higher score means more severe anxiety. | The 1 day of enrollment, and 3th day of ICU. | 
| Change from baseline on Post-traumatic stress disorder(PTSD) | The PTSD is assessed by Post-traumatic Stress Syndrome 10-question inventory (PTSS-10).The measurement involved 10 items and each item is rated using a seven-point Likert scale (1 never to 7 always). | The 1st, and 3th day of ICU. | 
| Change of Delirium incidence | The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU) | Every 8 hours during ICU stay up to 3 days | 
| Change from baseline on depression | Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score>9 is associated with depression. The higher score means more severe depression. | The 1 day of enrollment, and 3th day of ICU. | 
| Change from baseline on stress | Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 7 items of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score>14 is associated with anxiety. The higher score means more severe stress. | The 1 day of enrollment, and 3th day of ICU. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Pain | Pain is assessed by using the Critical-Care Pain Observation Tool (CPOT). The possible total score ranges from 0 (no pain) to 8 (maximum pain). | Everyday during ICU stay up to 3 days | 
| Change from baseline on sleep quality | Sleep quality in ICU is assessed by the Richards-Campbell Sleep Questionnaire(RCSQ). The mean of total score is 0-100. The higher score means the better sleep quality. | The 1st, and 3th day of ICU. | 
| ICU acquired weakness | The ICU acquired weakness is assessed by Medical Research Council (MRC).The scale for grading the strength (i.e., 0, total palsy to 5, normal strength) in three functional muscle groups of each extremity (shoulder abduction, elbow flexion, and wrist extension for upper limb; hip flexion, knee extension, and ankle dorsiflexion for lower limb), with mean MRC-scores of <4 (antigravity strength).26,35 Summation of scores gives MRC-sums core, ranging from 0 to 60. The sum score also reliably identifies significant ICU-acquired weakness (< 48). | The 1st day of ICU. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intensive care unit, Hand-grip Strength