EmotionsNCT02830711
The Impact of a 3-day High-altitude Mountain Trek on the Emotional States of Children
An observational study of Emotions, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotions
- What is being tested?
- Positive and Negative Affect Scale for Children
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jun 2011
- Phase
- Observational
- 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 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Emotions
- Being tested
- Positive and Negative Affect Scale for Children
- Keywords
- happiness, anger, sadness, anticipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive and Negative Affect Scale for ChildrenOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month before the trek and 1 week after the trek.
Secondary outcomes (8)
Age
Age in years
Measured: 1 month before the trek.
Gender
Gender in male or female
Measured: 1 month before the trek.
Weight
Weight in kilograms
Measured: 1 month before the trek.
Height
Height in centimeters
Measured: 1 month before the trek.
Blood type
Blood type in A, B, O, or AB blood types
Measured: 1 month before the trek.
Family configuration-father's and mother's Education level
Junior high school, Senior high school, College, University, Graduate school, PH.D. or other
Measured: 1 month before the trek.
Family configuration-All Siblings
1st, 2nd, 3rd, or 4th child
Measured: 1 month before the trek.
Family configuration-live with which family or families
Live with both parents, mother only, father only, grandparents, or other relatives.
Measured: 1 month before the trek.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startMay 2011
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHIH-HAO WANG, MD, Chang Gung Memorial Hospital
- Investigators
- SHIH-HAO WANG, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830711
- Sponsor's protocol ID
- 100-0921B
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a 3-day High-altitude Mountain Trek on the Emotional States of Children
- ClinicalTrials.gov ID
- NCT02830711
- Acronym / sponsor ID
- 100-0921B
- Conditions
- Emotions
- Keywords
- happiness, anger, sadness, anticipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Positive and Negative Affect Scale for ChildrenA 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 | Other | – |
Primary outcome
Change from baseline Emotion States (happiness, anticipation, sadness, and anger) at 1 week after the trek.
Time frame: 1 month before the trek and 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).
8 secondary outcomes
Age
Time frame: 1 month before the trek.
Gender
Time frame: 1 month before the trek.
Weight
Time frame: 1 month before the trek.
Height
Time frame: 1 month before the trek.
Blood type
Time frame: 1 month before the trek.
Family configuration-father's and mother's Education level
Time frame: 1 month before the trek.
Family configuration-All Siblings
Time frame: 1 month before the trek.
Family configuration-live with which family or families
Time frame: 1 month before the trek.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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Healthy Adult Participants
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.
SHIH-HAO WANG principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Emotions, run by Chang Gung Memorial Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change from baseline Emotion States (happiness, anticipation, sadness, and anger) at 1 week after the trek. (time frame: 1 month before the trek and 1 week after the trek.). 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 13 Jul 2016.