NCT05575349

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

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Dec 2022

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

First Submitted

Initial submission to the registry

October 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

October 7, 2022

Last Update Submit

December 11, 2023

Conditions

Keywords

ClimacteriumAnxietyQuality of lifeMandala coloring

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

EXPERIMENTAL

Mandala painting will be applied to climacteric women with anxiety.

Other: Mandala coloring

Control group

NO INTERVENTION

Participants 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.

Mandala coloring group

Eligibility Criteria

Age42 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Kırklareli Training and Research Hospital

Kırklareli, Centre, 39000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ayça ŞOLT KIRCA

    Kırklareli University

    PRINCIPAL INVESTIGATOR
  • Efsun DERIN

    Kırklareli University

    STUDY DIRECTOR
  • ELIF DAGLI

    Cukurova University

    STUDY DIRECTOR

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

Locations