AnxietyNCT05053178
The Effect of Mindfulness-Based Mandala Activity on Anxiety and Spiritual Well-Being Levels of Senior Nursing Students
A study testing Mindfulness-based mandala activity in people with Anxiety and Nursing Caries, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Nursing Caries, ART
- What is being tested?
- Mindfulness-based mandala activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2021to 30 Jun 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
- 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
Who cannot join
- Receiving psychiatric treatment (pharmacological and/or psychotherapy),
- with substance addiction,
- Must have participated in any meditation-based therapy program before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Nursing Caries, ART
- Being tested
- Mindfulness-based mandala activity
- Keywords
- art therapy; nursing student; anxiety, spirituality;
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based mandala activityBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Mindfulness-based mandala activity |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Spiritual well-being scale
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.
Measured: Change from Baseline level of Spiritual well being scale at 3 weeks (change is being assessed)
The Spielberger State-Trait Anxiety Inventory (STAI)
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.
Measured: Change from Baseline level of The Spielberger State-Trait Anxiety Inventory at 3 weeks (change is being assessed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start10 May 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Sarı Öztürk, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053178
- Sponsor's protocol ID
- 2021/626
- Status last verified
- Sep 2021
- First submitted
- 11 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sari Ozturk C, Kilicarslan Toruner E. The effect of mindfulness-based mandala activity on anxiety and spiritual well-being levels of senior nursing students: A randomized controlled study. Perspect Psychiatr Care. 2022 Oct;58(4):2897-2909. doi: 10.1111/ppc.13138. Epub 2022 Jul 3.
PubMed 35780483
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Mandala Activity on Anxiety and Spiritual Well-Being
- ClinicalTrials.gov ID
- NCT05053178
- Acronym / sponsor ID
- 2021/626
- Conditions
- Anxiety, Nursing Caries, ART
- Keywords
- art therapy; nursing student; anxiety, spirituality;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Sep 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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mindfulness-based mandala activityMindfulness-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. |
| Control group | No intervention | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Receiving psychiatric treatment (pharmacological and/or psychotherapy),
- with substance addiction,
- Must have participated in any meditation-based therapy program before.
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 |
|---|---|---|
| Mindfulness-based mandala activityMindfulness-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 | Behavioural | Intervention group |
Primary outcome
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.
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.
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 22 Sep 2021.
- Derived from this study: PubMed 35780483Sari Ozturk C, Kilicarslan Toruner E. The effect of mindfulness-based mandala activity on anxiety and spiritual well-being levels of senior nursing students: A randomized controlled study. Perspect Psychiatr Care. 2022 Oct;58(4):2897-2909. doi: 10.1111/ppc.13138. Epub 2022 Jul 3.
- Individual participant dataSharing planned: No
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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 Mindfulness-based mandala activity in people with Anxiety and Nursing Caries, run by Gazi University 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 3 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: finished, as of the sponsor's last update on 22 Sep 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?
Spiritual well-being scale (time frame: Change from Baseline level of Spiritual well being scale at 3 weeks (change is being assessed)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05053178, which also lists 1 linked publication.
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 22 Sep 2021.