DepressionNCT03906396
Exergame on Sleep and Emotion Among Students
A study testing Xbox 360 Kinect in people with Depression and Sleep, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Sleep, Anxiety
- What is being tested?
- Xbox 360 Kinect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 Feb 2019to 7 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergraduate healthcare students
- Able to read and understand English version questionnaire
- Having BMI <25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression, Sleep, Anxiety, Stress
- Being tested
- Xbox 360 Kinect
- Keywords
- xbox kinect, gaming technology, stress, anxiety, depression, randomised control trial, sleep quality, intervention
- Medical subject headings
- Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xbox 360 KinectDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+)
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start27 Feb 2019
- Primary completion30 Mar 2019
- Study completion7 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: Using the Xbox 360 Kinect Control Group: No intervention, continue with daily routine
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farahiyah Wan Yunus, National University of Malaysia
- Investigators
- Muhammad Hibatullah Romli, PhD, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906396
- Sponsor's protocol ID
- NN-2018-167
- Status last verified
- Feb 2020
- First submitted
- 3 Apr 2019
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol can be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of Exergame on Sleep and Emotion Among University Students
- ClinicalTrials.gov ID
- NCT03906396
- Acronym / sponsor ID
- NN-2018-167
- Conditions
- Depression, Sleep, Anxiety, Stress
- Keywords
- xbox kinect, gaming technology, stress, anxiety, depression, randomised control trial, sleep quality, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 7 Apr 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group: Using the Xbox 360 Kinect Control Group: No intervention, continue with daily routine
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Xbox 360 KinectA 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. |
| Control Group | No intervention | –No standard activity is provided for the participants. The participants will continue with their normal daily life activities. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Undergraduate healthcare students
- Able to read and understand English version questionnaire
- Having BMI <25
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xbox 360 KinectA 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. | Device | Intervention Group |
Primary outcome
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+)
Functional Outcome of Sleep Questionnaire (FOSQ-30)
Time frame: 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No. Study protocol can be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Hibatullah Romli, PhD principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xbox 360 Kinect in people with Depression and Sleep, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety and Stress Scales Questionnaire (DASS-21) (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.