Interactive Hand-grip Strength Game in Critically Illness Patients

NCT05298241 | Completed

• 1 other identifier: N202102007
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

intensive care unit; Hand-grip Strength

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Changes of Pain

  Everyday during ICU stay up to 3 days

• Change from baseline on sleep quality

  The 1st, and 3th day of ICU.

• ICU acquired weakness

  The 1st day of ICU.

Study Arms (2)

Hand-grip Strength Game

EXPERIMENTAL

Participants will receive a hand-grip strength game for 5-20 minutes twice a day for consecutive three days.

Other: Hand-grip Strength Game

routine care

NO INTERVENTION

The control group will not involve hand-grip strength game at night.

Interventions

Hand-grip Strength Game OTHER

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

Hand-grip Strength Game

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Suspect neurological deficits
• Neuromuscular disease
• Orthopedic injuries with contraindications to mobilize

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

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

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsiao-Yean Chiu, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: March 28, 2022
• Study Start: October 21, 2021
• Primary Completion: November 21, 2022
• Study Completion: December 1, 2022
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

TW (1)