Health BehaviorNCT04815057
The Effects of Wellness Training Given to Fifth Grade Students During the Covid-19 Epidemic Period
A study testing Wellness Education in people with Health Behavior, run by Sumeyra Yılmaz at 1 site in Turkey (Türkiye).
Trial summary
This study conducted an experimental study with a randomized control group to decide on the quality of life and physical activity of the Wellness education for fifth grade students during the Covid-19 pandemic process. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Wellness Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2020to 8 Mar 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a fifth grade student,
- Not having any physical or mental disability,
- Agree to participate in research,
- Not allowed to participate in research by their parents.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Wellness Education Given to 5th Grade Students During the Covid-19 Pandemic Process on Their Quality of Life and Physical Activity
This study conducted an experimental study with a randomized control group to decide on the quality of life and physical activity of the Wellness education for fifth grade students during the Covid-19 pandemic process.
Read the detailed description
After the population and sample calculations were made, the students who had their pre-tests were randomized to the Wellness Education Group and the Control Group. In this study conducted in two state secondary schools affiliated to Kırşehir Provincial Directorate of National Education, the experimental group was given Wellness training. No intervention was made to the control group. Four weeks after the training, the students were post-tested and the data were analyzed.
In order not to affect the groups from the practices to be made, first of all, schools were randomized and the schools were divided into Wellness Education Group and Control Group with a closed envelope lot method. Prof. Dr. Erol Güngör Secondary School (Group I) Wellness Education Group has been assigned to Kırşehir Merkez Yunus Emre Secondary School (Group II) Control Group. Experimental and control groups in order to reduce selection bias and control variables that may have an effect on outcome variables; A randomized assignment was made by a statistician who did not know the names and characteristics of the students. In determining the students to be included in the study; Student lists and the Excel 2016 program were used, and Simple Random Sampling was performed. The student lists assigned to the groups by the expert were submitted to the researcher before the initiatives started.
- Conditions
- Health Behavior
- Being tested
- Wellness Education
- Keywords
- wellness, adolescent, quality of life, physical activity
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness EducationBehavioural
The wellness education given to fifth grade students and the quality of life, its effect on physical activity status
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | wellness education Receives: Behavioral: Wellness Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish child physical activity questionnaire
The predictive self-report gazelle is a seven-day recall scale to assess mid-to-high physical activity in children aged -14 years. Calculation of the total score of the questionnaire; The score obtained after adding the scores of the answers to the questions 1, 2, 3, 4, 5, 6, 7, 8, and 9 and dividing by the number of questions is the total physical activity score of the child from the questionnaire.
It is conducted on a 5-point scale for each item of the questionnaire and has a score between 1-5. "1" indicates low physical activity, "5" indicates high physical activity. A high score means good physical activity.
Measured: 3month
Secondary outcomes (1)
quality of life scale for children
quality of life score of students will increase after education, Items score between 0 and 100. Never 100 points, rarely He gets 75 points, sometimes 50 points, often 25 points and almost always 0 points. 5-7 years old child In his form he never gets 100 points, sometimes 50 points and often 0 points. Taken from substances The total score of the scale is obtained by dividing the scores by the number of filled items., high score means good quality of life
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start2 Nov 2020
- Primary completion23 Nov 2020
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumeyra Yılmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sumeyra Yılmaz, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815057
- Sponsor's protocol ID
- Sağlık Bilimleri Univesity
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Wellness Education Given to 5th Grade Students During the Covid-19 Pandemic Process on Their Quality of Life and Physical Activity
- ClinicalTrials.gov ID
- NCT04815057
- Acronym / sponsor ID
- Sağlık Bilimleri Univesity
- Conditions
- Health Behavior
- Keywords
- wellness, adolescent, quality of life, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Sumeyra YılmazUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 24 Mar 2021 (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 conducted an experimental study with a randomized control group to decide on the quality of life and physical activity of the Wellness education for fifth grade students during the Covid-19 pandemic process.
Detailed description
After the population and sample calculations were made, the students who had their pre-tests were randomized to the Wellness Education Group and the Control Group. In this study conducted in two state secondary schools affiliated to Kırşehir Provincial Directorate of National Education, the experimental group was given Wellness training. No intervention was made to the control group. Four weeks after the training, the students were post-tested and the data were analyzed.
In order not to affect the groups from the practices to be made, first of all, schools were randomized and the schools were divided into Wellness Education Group and Control Group with a closed envelope lot method. Prof. Dr. Erol Güngör Secondary School (Group I) Wellness Education Group has been assigned to Kırşehir Merkez Yunus Emre Secondary School (Group II) Control Group. Experimental and control groups in order to reduce selection bias and control variables that may have an effect on outcome variables; A randomized assignment was made by a statistician who did not know the names and characteristics of the students. In determining the students to be included in the study; Student lists and the Excel 2016 program were used, and Simple Random Sampling was performed. The student lists assigned to the groups by the expert were submitted to the researcher before the initiatives started.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Wellness Educationwellness education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being a fifth grade student,
- Not having any physical or mental disability,
- Agree to participate in research,
- Not allowed to participate in research by their parents.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Wellness EducationThe wellness education given to fifth grade students and the quality of life, its effect on physical activity status | Behavioural | Education |
Primary outcome
Turkish child physical activity questionnaire
Time frame: 3month
The predictive self-report gazelle is a seven-day recall scale to assess mid-to-high physical activity in children aged -14 years. Calculation of the total score of the questionnaire; The score obtained after adding the scores of the answers to the questions 1, 2, 3, 4, 5, 6, 7, 8, and 9 and dividing by the number of questions is the total physical activity score of the child from the questionnaire. It is conducted on a 5-point scale for each item of the questionnaire and has a score between 1-5. "1" indicates low physical activity, "5" indicates high physical activity. A high score means good physical activity.
1 secondary outcome
quality of life scale for children
Time frame: 3 month
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 14 Apr 2021.
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Education in people with Health Behavior, run by Sumeyra Yılmaz at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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 14 Apr 2021. 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 Turkey (Türkiye). 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?
Turkish child physical activity questionnaire (time frame: 3month). 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 14 Apr 2021.