Interactive Hand-grip Strength Game in Critically Illness Patients

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Other: Hand-grip Strength Game

• Registration Number: NCT05298241
• Lead Sponsor: Taipei Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-10-21
• Study First Submitted: 2022-01-30
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-03-28
• Primary Completion: 2022-11-21
• Study Completion: 2022-12-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand-grip Strength Game	Hand-grip Strength Game	Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days.

Primary Outcome Measures

Name	Time	Method
Change from baseline on Post-traumatic stress disorder(PTSD)	The 1st, and 3th day of ICU.	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").
Change from baseline on stress	The 1 day of enrollment, and 3th day of ICU.	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.
Change from baseline on depression	The 1 day of enrollment, and 3th day of ICU.	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.
Change of Delirium incidence	Every 8 hours during ICU stay up to 3 days	The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU)
Change from baseline on anxiety	The 1 day of enrollment, and 3th day of ICU.	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.

Secondary Outcome Measures

Name	Time	Method
ICU acquired weakness	The 1st day of ICU.	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).
Change from baseline on sleep quality	The 1st, and 3th day of ICU.	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.
Changes of Pain	Everyday during ICU stay up to 3 days	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).

Trial Locations

Locations (1)

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare; 🇨🇳 Taipei, Taiwan