Clinical trial NCT05298241: Interactive Hand-grip Strength Game in Critically Illness Patients
Official title: Effects of Interactive Hand-grip Strength Game in Critically Illness Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: intensive care unit
Hand-grip Strength
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline on anxiety
timeFrame: The 1 day of enrollment, and 3th day of ICU.
measure: Change from baseline on Post-traumatic stress disorder(PTSD)
timeFrame: The 1st, and 3th day of ICU.
measure: Change of Delirium incidence
timeFrame: Every 8 hours during ICU stay up to 3 days
measure: Change from baseline on depression
timeFrame: The 1 day of enrollment, and 3th day of ICU.
measure: Change from baseline on stress
timeFrame: The 1 day of enrollment, and 3th day of ICU.
Secondary outcomes:
measure: Changes of Pain
timeFrame: Everyday during ICU stay up to 3 days
measure: Change from baseline on sleep quality
timeFrame: The 1st, and 3th day of ICU.
measure: ICU acquired weakness
timeFrame: The 1st day of ICU.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare
Study officials:
affiliation: Taipei Medical University
name: Hsiao-Yean Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References: