- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906396
Exergame on Sleep and Emotion Among Students
February 24, 2020 updated by: Farahiyah Wan Yunus, National University of Malaysia
Investigating the Feasibility of Exergame on Sleep and Emotion Among University Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sleep deprivation and emotional problems such as stress, anxiety and depression commonly occur in university students.
Exercise is beneficial to ameliorate those problems however university students are not serious to uptake physical activity.
Commercially available exergame such as Xbox 360 Kinect is one of the alternatives.
This study aims to investigate the feasibility and the potential efficacy of using Xbox 360 Kinect game among healthcare undergraduate students.
A pilot two-armed parallel randomized controlled trial was implemented.
A total of 36 undergraduate students was recruited and randomly allocated into the intervention group (playing Xbox 360 Kinect) or the control group (continue with normal daily routine).
The intervention group received 30 minutes of Xbox Kinect activity, three times per week for six weeks.
Information on psychology (DASS-21) and sleep (FOSQ-30) status were collected at pre- and post-experiment.
The researcher-developed feasibility questionnaire was given to the participants in the intervention group at post-experiment.
Repeated-measures ANOVA analysis was used to investigate within-between group comparison and significant value was set at p≤0.05.
The analysis found potential improvement on sleep (p=0.039) and psychological health (p=0.002-0.067).
The intervention protocol is feasible and highly accepted by the participants.
Required optimum amount of dosage, sample size and used of outcome measures are suggested from the findings.
This pilot and feasibility study support the use of Xbox 360 Kinect games in practice and to be implemented for future research.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kuala Lumpur, Malaysia, 53200
- Kolej Tun Syed Nasir
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Undergraduate healthcare students
- Able to read and understand English version questionnaire
- Having BMI <25
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention Group
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.
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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.
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NO_INTERVENTION: Control Group
No standard activity is provided for the participants.
The participants will continue with their normal daily life activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Anxiety and Stress Scales Questionnaire (DASS-21)
Time Frame: 1 week
|
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+)
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1 week
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Functional Outcome of Sleep Questionnaire (FOSQ-30)
Time Frame: 1 week
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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.
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1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Hibatullah Romli, PhD, Universiti Putra Malaysia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 27, 2019
Primary Completion (ACTUAL)
March 30, 2019
Study Completion (ACTUAL)
April 7, 2019
Study Registration Dates
First Submitted
April 3, 2019
First Submitted That Met QC Criteria
April 4, 2019
First Posted (ACTUAL)
April 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 26, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN-2018-167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Study protocol can be shared with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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