Exergame on Sleep and Emotion Among Students

Depression Clinical Trial

Official title:

Investigating the Feasibility of Exergame on Sleep and Emotion Among University Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906396
• Other study ID #: NN-2018-167
• Status: Completed
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: April 7, 2019

Study information

• Verified date: February 2020
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Two outcome measures will be used at pre and post intervention.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 7, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Sleep
• Stress

Intervention

Device:
• Xbox 360 Kinect
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.

Locations

Country	Name	City	State
Malaysia	Kolej Tun Syed Nasir	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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