- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053178
The Effect of Mindfulness-Based Mandala Activity on Anxiety and Spiritual Well-Being Levels of Senior Nursing Students
September 21, 2021 updated by: Çiğdem Sarı Öztürk, Gazi University
The Effect of Mindfulness-Based Mandala Activity on Anxiety and Spiritual Well-Being
This research was conducted to determine the effect of mindfulness-based mandala activity on the spiritual well-being and anxiety levels of senior nursing students in a parallel-group pretest-posttest randomized controlled study design.
The required institutional permission and ethics committee approval was received.
The study group of the study consisted of 170 senior nursing students (intervention group [n=84], control group [n=86]).
Mindfulness-based mandala activity was applied to the intervention group via the zoom online program.
Data were collected using the descriptive features form, the Spielberg Trait, and State Anxiety Inventory, the Spiritual Well-Being Scale, and the scale of the positive-negative experience.
The data were stored in the SPSS 24 program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research was conducted to determine the effect of mindfulness-based mandala activity on the spiritual well-being and anxiety levels of senior nursing students in a parallel-group pretest-posttest randomized controlled study design.
The required institutional permission and ethics committee approval was received.
The study group of the study consisted of 170 senior nursing students (intervention group [n=84], control group [n=86]).
Mindfulness-based mandala activity was applied to the intervention group via the zoom online program.
Data were collected using the descriptive features form, the Spielberg Trait, and State Anxiety Inventory, the Spiritual Well-Being Scale, and the positive-negative experiences scale.
Students will be divided into groups of 6-10 and mandala activities will be carried out.
3 weeks of mandala activity, breathing exercises, affirmations, etc. a therapeutic application program was created and implemented.
For the students in the control group, the standard support program given by the school administration and course instructors will be applied for clinical problems.
At the end of the study, it is planned to apply mandala activities among the students in the control group.
The research is based on Watson's "Human Caring" theory.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Gazi University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Registering the theoretical and practical courses within the scope of Nursing Vocational Courses Application II,
- with internet access,
- Students who agree to participate in the study
Exclusion Criteria:
- Receiving psychiatric treatment (pharmacological and/or psychotherapy),
- with substance addiction,
- Must have participated in any meditation-based therapy program before.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Mindfulness-based mandala activity was applied to the intervention group via the zoom online program.
Students will be divided into groups of 6-10 and mandala activities will be carried out.
3 weeks of mandala activity, breathing exercises, affirmations, etc. a therapeutic application program was created and implemented.
|
Mindfulness-based mandala activity was applied to the intervention group via the zoom online program.
Students will be divided into groups of 6-10 and mandala activities will be carried out.
3 weeks of mandala activity, breathing exercises, affirmations, etc. a therapeutic application program was created and implemented
|
NO_INTERVENTION: Control group
For the students in the control group, the standard support program given by the school administration and course instructors will be applied for clinical problems.
At the end of the study, it is planned to apply mandala activities among the students in the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spiritual well-being scale
Time Frame: Change from Baseline level of Spiritual well being scale at 3 weeks (change is being assessed)
|
The scale consists of 29 items and is a five-point Likert type.
The lowest score of 29 points and the highest of 145 points are obtained from the scale.
The higher the score indicates a higher spirituality well being.
|
Change from Baseline level of Spiritual well being scale at 3 weeks (change is being assessed)
|
The Spielberger State-Trait Anxiety Inventory (STAI)
Time Frame: Change from Baseline level of The Spielberger State-Trait Anxiety Inventory at 3 weeks (change is being assessed)
|
The scale is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item.
The total score obtained from the scale varies between 20 and 80.
A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
|
Change from Baseline level of The Spielberger State-Trait Anxiety Inventory at 3 weeks (change is being assessed)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 10, 2021
Primary Completion (ACTUAL)
June 30, 2021
Study Completion (ACTUAL)
June 30, 2021
Study Registration Dates
First Submitted
September 11, 2021
First Submitted That Met QC Criteria
September 21, 2021
First Posted (ACTUAL)
September 22, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 22, 2021
Last Update Submitted That Met QC Criteria
September 21, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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