NCT05053178

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

September 11, 2021

Last Update Submit

September 21, 2021

Conditions

AnxietyNursing CariesART

Keywords

art therapy; nursing student; anxietyspirituality;

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

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.

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

Interventions

Mindfulness-based mandala activityBEHAVIORAL

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

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Receiving psychiatric treatment (pharmacological and/or psychotherapy),
  • with substance addiction,
  • Must have participated in any meditation-based therapy program before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 35780483DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Cigdem Sarı Ozturk-Principal Investigator

Study Record Dates

First Submitted

September 11, 2021

First Posted

September 22, 2021

Study Start

May 10, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)