Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-04 @ 7:40 PM
Study NCT ID:
NCT04815057
Status:
COMPLETED
Last Update Posted:
2021-04-14
First Post:
2021-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Wellness Training Given to Fifth Grade Students During the Covid-19 Epidemic Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'the researchers evaluating the outcomes were blinded in determining the groups.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-11', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turkish child physical activity questionnaire', 'timeFrame': '3month', 'description': '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.\n\nIt 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.'}], 'secondaryOutcomes': [{'measure': 'quality of life scale for children', 'timeFrame': '3 month', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wellness', 'adolescent', 'quality of life', 'physical activity'], 'conditions': ['Health Behavior']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a fifth grade student,\n* Not having any physical or mental disability,\n* Agree to participate in research,\n* Not allowed to participate in research by their parents.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04815057', 'briefTitle': 'The Effects of Wellness Training Given to Fifth Grade Students During the Covid-19 Epidemic Period', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effects of Wellness Education Given to 5th Grade Students During the Covid-19 Pandemic Process on Their Quality of Life and Physical Activity', 'orgStudyIdInfo': {'id': 'Sağlık Bilimleri Univesity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education', 'description': 'wellness education', 'interventionNames': ['Behavioral: Wellness Education']}], 'interventions': [{'name': 'Wellness Education', 'type': 'BEHAVIORAL', 'description': 'The wellness education given to fifth grade students and the quality of life, its effect on physical activity status', 'armGroupLabels': ['Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Second School', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sumeyra Yılmaz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Responsible investigator', 'investigatorFullName': 'Sumeyra Yılmaz', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}