Exergame on Sleep and Emotion Among Students

NCT03906396 | Completed

• 1 other identifier: NN-2018-167
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the feasibility and the potential efficacy of using Xbox 360 Kinect game among healthcare undergraduate students. Thirty-six participants will be recruited and randomly allocated into the intervention and control group. The session will be 30 minutes per session for three times per week. Two outcome measures will be used at pre and post intervention.

Conditions

Depression; Sleep; Anxiety; Stress

Keywords

xbox kinect; gaming technology; stress; anxiety; depression; randomised control trial; sleep quality; intervention

Outcome Measures

Primary Outcomes (2)

• Depression, Anxiety and Stress Scales Questionnaire (DASS-21)

  The Depression, Anxiety and Stress Scale -21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. Scoring for each scale is from 0 to 3 (Never:0; Sometimes:1; Often:2; Almost Always:3). Overall score is summed to indicate if the person has depression, anxiety or stress. For depression total score indicators (Normal:0-4; Mild:5-6; Moderate:7-10; Severe:11-13; Extremely Severe:14+). For anxiety total score indicators (Normal: 0-3; Mild:4-5; Moderate:6-7; Severe: 8-9; Extremely Severe: 10+). For stress total score indicators (Normal:0-7; Mild: 8-9; Moderate: 10-12; Severe: 13-16; Extremely Severe: 17+)

  1 week

• Functional Outcome of Sleep Questionnaire (FOSQ-30)

  Consisting of 30 questions related to the effects of fatigue on daily activities, the instrument was designed to evaluate the respondent's quality of life as it relates to disorders of excessive sleepiness. In 30 items, the FOSQ then assesses difficulty, due to sleepiness, in performing activities of daily living and recreational activities, which are categorized into the following 5 subscales: 1) activity level (9 items), 2) vigilance (7 items), 3) intimacy and sexual relationships (4 items), 4) general productivity (8 items), and 5) social outcomes (2 items). Scoring is from 0-4 (0: I don't do this activity for other reasons; 1: Yes, Extremely Difficult; 2: Yes, Moderate Difficulty; 3: Yes, Little Difficulty: 4: No Difficulty. The potential range of scores for the Total Score is 5 -20. Lower Score indicates more difficulty performing everyday activities when tired or sleepy, while higher score indicates less difficulty performing everyday activities when tired or sleepy.

  1 week

Study Arms (2)

Intervention Group

EXPERIMENTAL

A session 30 minutes of exercise game activities using the Xbox 360 Kinect will be performed by each participant for 6 weeks, 3 times per week. Games use for the activity are Sports Kinect and Sports Kinect 2. The activity can be performed in solo or in pairs with another participant. The game activity will be played only at the site chosen for this study.

Device: Xbox 360 Kinect

Control Group

NO INTERVENTION

No standard activity is provided for the participants. The participants will continue with their normal daily life activities.

Interventions

Xbox 360 Kinect DEVICE

A session 30 minutes of exercise game activities using the Xbox 360 Kinect will be performed by each participant. Games uses for the activity are Sports Kinect and Sports Kinect 2. Xbox 360 Kinect - the players themselves become the ''game controller'' via their body movements and gestures, Kinect-enabled game titles lend themselves comfortably to the class of exercise games.

Intervention Group

Eligibility Criteria

• Age: 19 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergraduate healthcare students
• Able to read and understand English version questionnaire
• Having BMI \<25

You may not qualify if:

• Person with condition (i.e. asthma, heart problem) that prevent from participating in active physical activities.
• Known history of mental health issues
• Visually impaired students iv. Postgraduate students

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Kolej Tun Syed Nasir

Kuala Lumpur, 53200, Malaysia

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Muhammad Hibatullah Romli, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: i) A number of assessors from occupational therapy students will be recruited. This is to allow for randomization possibility on assessment responsibility. 1. Pre-evaluation is conducted randomly by accident by an independent assessor with an occupational therapy background without knowing which participant in which group. There is no specific client on specific assessor. 2. The post-evaluation is conducted randomly by accident by an independent assessor with an occupational therapy background. There is no specific client on specific assessor. ii) Information among participants is kept confidential and blinding from each other. No cross-over is allowed to reduce bias.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group: Using the Xbox 360 Kinect Control Group: No intervention, continue with daily routine

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 8, 2019
• Study Start: February 27, 2019
• Primary Completion: March 30, 2019
• Study Completion: April 7, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)