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NCT Number: NCT05298241

Interactive Hand-grip Strength Game in Critically Illness Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand-grip Strength Game

Other

Interactive Handgrip Strength Game for ICU patients receiving the game and to assess the impact on psychological.

Primary outcomes

  1. Change from baseline on anxiety

    Time frame: 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.

  2. Change from baseline on Post-traumatic stress disorder(PTSD)

    Time frame: 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").

  3. Change of Delirium incidence

    Time frame: Every 8 hours during ICU stay up to 3 days

    The delirium event is assessed by Confusion Assessment Method for the ICU(CAM-ICU)

  4. Change from baseline on depression

    Time frame: 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.

  5. Change from baseline on stress

    Time frame: 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.

Secondary outcomes

  1. Changes of Pain

    Time frame: 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).

  2. Change from baseline on sleep quality

    Time frame: 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.

  3. ICU acquired weakness

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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