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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05053178
Other study ID # 2021/626
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2021
Est. completion date June 30, 2021

Study information

Verified date September 2021
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-based mandala activity
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

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline level of Spiritual well being scale at 3 weeks (change is being assessed)
Primary 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. Change from Baseline level of The Spielberger State-Trait Anxiety Inventory at 3 weeks (change is being assessed)
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