Applying Short-term Interactive Video Games on Community Patients With Mental Disorders

Nursing Clinical Trial

Official title:

Intervention Feasibility and Outcomes Evaluation of Applying Short-term Interactive Video Games on Community Patients With Mental Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04346303
• Other study ID #: 202001106RIND
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: National Taiwan University Hospital
• Contact: Chang Jung-Chen, PhD
• Phone: (02)223123456
• Email: jungchenchang[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:

1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.

2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).

3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.

Description:

The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:

1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.

2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).

3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.

Primary Outcome Measure:

The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form) After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.

[Time Frame: 5 Weeks]

Secondary Outcome Measures:

Body Mass Index Measuring height and weight [Time Frame: 5 Weeks]

Waist-hip ratio Measuring the ratio of waist to hip [Time Frame: 5 Weeks]

10-m walking time at comfortable Measuring the 10-m walking time at comfortable [Time Frame:

5 Weeks]

10-m walking time at maximum Measuring the 10-m walking time at maximum [Time Frame: 5 Weeks]

Get Up and Go test Measuring the Get Up and Go test [Time Frame: 5 Weeks]

5 times sit-to-stand test Measuring the 5 times sit-to-stand test [Time Frame: 5 Weeks]

Hierarchy of the Care Required This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.

[Time Frame: 5 Weeks]

CHQ-12 (Chinese Health Questionnaire) This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.

[Time Frame: 5 Weeks]

Short FES-I (Chinese version of the Falls Efficacy Scale ) This is a 7-item scale to assess patient's vulnerability to fall. [Time Frame: 5 Weeks]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• The diagnosis conforms to the international classification standards for the diagnosis of dysphoria or bipolar disorder.

• Be older than 20 years old.

• those who have a clear sense and can communicate.

• You can read the instructions carefully, and after you explain, you are willing to participate in the research plan and fill out the consent form.

• The judges of the researchers can independently answer the interview questionnaires of this research and perform short-term interactive video game players.

• At present, you can go out, make friends, take care of yourself, and fully exercise your rights. You have the full capacity of an adult and have not been restricted by any laws. Therefore, you do not need to obtain an additional legal agent to participate in this study Sign the consent form.

Exclusion Criteria:

• People with difficulties in cognitive understanding, such as those who cannot communicate or suffer from cognitive impairments, such as Alzheimer's disease.

• Those who have obvious obstacles to the physical function of their limbs, who are unable to participate in sports video games.

• Slow development or lack of moderate intelligence may affect the understanding of interviews or participation in activities.

• The physical and mental condition has been unstable in the past two weeks, such as instability of vital signs or obvious impaired sense of reality, obvious symptoms of delusions or hallucinations, etc., cannot be interviewed or coordinated with activities.

Related Conditions & MeSH terms

• Mental Disorders
• Nursing
• Psychiatry
• Psychotic Disorders

Intervention

Other:
• Short-term Interactive Video Games
Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2). After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form)	After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.	5 Weeks
Secondary	Body Mass Index	Measuring height and weight	5 Weeks
Secondary	Waist-hip ratio	Measuring the ratio of waist to hip	5 Weeks
Secondary	10-m walking time at comfortable	Measuring the 10-m walking time at comfortable	5 Weeks
Secondary	10-m walking time at maximum	Measuring the 10-m walking time at maximum	5 Weeks
Secondary	Get Up and Go test	Measuring the Get Up and Go test	5 Weeks
Secondary	5 times sit-to-stand test	Measuring the 5 times sit-to-stand test	5 Weeks
Secondary	Hierarchy of the Care Required	This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.	5 Weeks
Secondary	CHQ-12 (Chinese Health Questionnaire)	This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.	5 Weeks
Secondary	Short FES-I (Chinese version of the Falls Efficacy Scale )	This is a 7-item scale to assess patient's vulnerability to fall.	5 Weeks