Clinical trial NCT03906396: Exergame on Sleep and Emotion Among Students
Official title: Investigating the Feasibility of Exergame on Sleep and Emotion Among University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Sleep
Anxiety
Stress
Keywords: xbox kinect
gaming technology
stress
anxiety
depression
randomised control trial
sleep quality
intervention
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: Using the Xbox 360 Kinect Control Group: No intervention, continue with daily routine
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression, Anxiety and Stress Scales Questionnaire (DASS-21)
timeFrame: 1 week
measure: Functional Outcome of Sleep Questionnaire (FOSQ-30)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Kolej Tun Syed Nasir
Study officials:
affiliation: Universiti Putra Malaysia
name: Muhammad Hibatullah Romli, PhD
role: PRINCIPAL_INVESTIGATOR
References: