Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period
1 other identifier
interventional
80
1 country
1
Brief Summary
This research was planned as a randomized controlled experimental study in order to reduce the anxiety felt and improve the quality of life by women in the climacteric period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Dec 2022
Shorter than P25 for not_applicable anxiety
1 active site
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
First Submitted
Initial submission to the registry
October 7, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedDecember 12, 2023
December 1, 2023
6 months
October 7, 2022
December 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Introductory Information Form
A form that includes questions about women's socio-demographic and menopausal and characteristics.
between one to six months
Secondary Outcomes (1)
the Spielberger State-Trait Anxiety Inventory (STAI) Scale
between one to six months
Other Outcomes (1)
Menopause-Specific Quality of Life Questionnaire
between one to six months
Study Arms (2)
Mandala coloring group
EXPERIMENTALMandala painting will be applied to climacteric women with anxiety.
Control group
NO INTERVENTIONParticipants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms
Interventions
Participants will be asked to choose the pages they want from 12 colored felt-tip pen paint sets and 12 mandala coloring pages given to each participant by the researcher for 6 weeks, 1 days a week, at any time of the day and for an average of 20-30 minutes each time, and paint them in the colors they want.
Eligibility Criteria
You may qualify if:
- Volunteering to participate in the research
- Fully answering survey and scale forms.
- Ability to read and understand Turkish
- Being in the climacteric period (42-65 years)
- Having 40 or more from STAI
You may not qualify if:
- Unwilling to continue working
- Having any problem that prevents communication (such as hearing, speaking, and understanding abilities),
- Taking medication for menopausal symptoms
- Using one of the pharmacological or non-pharmacological methods to reduce anxiety and receiving psychiatric treatment (Pharmacotherapy or psychotherapy).
- Surgical menopause
- Having a mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kırklareli Universitylead
- Cukurova Universitycollaborator
Study Sites (1)
Kırklareli Training and Research Hospital
Kırklareli, Centre, 39000, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayça ŞOLT KIRCA
Kırklareli University
- STUDY DIRECTOR
Efsun DERIN
Kırklareli University
- STUDY DIRECTOR
ELIF DAGLI
Cukurova University
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
- Assistant Professor
Study Record Dates
First Submitted
October 7, 2022
First Posted
October 12, 2022
Study Start
December 12, 2022
Primary Completion
June 17, 2023
Study Completion
June 30, 2023
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share