An interventional study of Hand-grip Strength Game in Critical Illness, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 70 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days.
Other: Hand-grip Strength Game
The control group will not involve hand-grip strength game at night.
Interactive Handgrip Strength Game for ICU patients receiving the game and to assess the impact on psychological.
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.
Time frame: 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").
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: The 1 day of enrollment, and 3th day of ICU.
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).
Time frame: 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.
Time frame: 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).
Time frame: The 1st day of ICU.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Taipei Medical University