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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02830711
Other study ID # 100-0921B
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 29, 2016
Last updated July 9, 2016
Start date May 2011

Study information

Verified date July 2016
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational

Clinical Trial Summary

The mood was influenced by many factors in children. Sport, such as high-altitude mountain trek activity was thought benefit for human's mood and health. The expedition therapy was more and more popular in many schools recently. However, as the investigators best knowledge, there was no article discuss the relation between the mood and high-altitude mountain trek activity such as benefit influence in children. So, the investigators conduct the study.

Method: Demographic data will be recorded. The Professor Yeh's mood questionnaires were used to record the mood status of before and after the 3 days high-altitude mountain trek activity.

Statistical analyses: Participants rated their emotional states (happiness, sadness, anticipation, and anger) on a Likert scale. Each variable will be presented as descriptive statistics. Student t test or other suitable statistical method(s) will be used to determine the correction among the variables with scores of mood status. The paired t test or other suitable statistical method(s) will be used to determine the correction among the scores of mood status before and after the mountain activity. A difference was considered statistically significant if the p value were less than 0.05. All statistical analyses will be performed using SPPS statistical software for Windows, version 14 or more updated version.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 13 Years
Eligibility Inclusion Criteria:

- Sixth-grade elementary students who participated in a 3-day, 2-night high-altitude mountain walking trek from the trailhead (2,140 m above sea level) to the summit of Xue Mountain (3,886 m above sea level)

- Subject who provide the written informed consent from participants and their legal guardians before the distribution of the questionnaires.

Exclusion Criteria:

- Not Sixth-grade elementary students.

- Not finish the 3-day, 2-night high-altitude mountain walking trek from the trailhead (2,140 m above sea level) to the summit of Xue Mountain (3,886 m above sea level)

- Subject who do not provide the written informed consent from participants and their legal guardians before the distribution of the questionnaires.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Positive and Negative Affect Scale for Children
A 36-item instrument, including the Mood and Anxiety Symptom Questionnaire (MASQ)16 developed by Chang and Yeh and the Positive and Negative Affect Scale for Children developed by Watson and Clark

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Emotion States (happiness, anticipation, sadness, and anger) at 1 week after the trek. A 36-item instrument, including the Mood and Anxiety Symptom Questionnaire was used to evaluate the four emotional states (happiness, anticipation, sadness, and anger). Specifically, 12 questions yielded the happy index, 10 questions yielded the sadness index, 9 questions yielded the anger index, and 5 questions yielded the anticipation index. A Likert scale ranging from 1 to 4 was used to evaluate individual items (1, strongly disagree; 2, disagree; 3, agree; and 4, strongly agree). 1 month before the trek and 1 week after the trek. No
Secondary Age Age in years 1 month before the trek. No
Secondary Gender Gender in male or female 1 month before the trek. No
Secondary Weight Weight in kilograms 1 month before the trek. No
Secondary Height Height in centimeters 1 month before the trek. No
Secondary Blood type Blood type in A, B, O, or AB blood types 1 month before the trek. No
Secondary Family configuration-father's and mother's Education level Junior high school, Senior high school, College, University, Graduate school, PH.D. or other 1 month before the trek. No
Secondary Family configuration-All Siblings 1st, 2nd, 3rd, or 4th child 1 month before the trek. No
Secondary Family configuration-live with which family or families Live with both parents, mother only, father only, grandparents, or other relatives. 1 month before the trek. No
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