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Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period

Primary Purpose

Anxiety, Climactericum

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mandala coloring
Sponsored by
Kırklareli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Climacterium, Anxiety, Quality of life, Mandala coloring

Eligibility Criteria

42 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Kırklareli Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mandala coloring group

Control group

Arm Description

Mandala painting will be applied to climacteric women with anxiety.

Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms

Outcomes

Primary Outcome Measures

Introductory Information Form
A form that includes questions about women's socio-demographic and menopausal and characteristics.

Secondary Outcome Measures

the Spielberger State-Trait Anxiety Inventory (STAI) Scale
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between 0,83 and 0,87. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.

Full Information

First Posted
October 7, 2022
Last Updated
May 5, 2023
Sponsor
Kırklareli University
Collaborators
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05575349
Brief Title
Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period
Official Title
Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period: Randomized Controlled Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
Collaborators
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Climacteric period; It is a life process in which the ovarian hormone and activity ends with a decrease, and the transition from the reproductive period to the non-reproductive period takes place, and includes perimenopause, menopause and postmenopausal stages. During the menopausal transition period, women experience many physical and psychological symptoms such as vasomotor symptoms, sleep disorders, depressed mood, and stress that negatively affect their quality of life. When the literature is examined, it can be seen that these menopausal symptoms experienced by women affect and trigger anxiety. Effective management of anxiety, which can negatively affect psychosocial well-being, social relations and mood, trigger or exacerbate menopausal symptoms, can improve the quality of life of women in the climacteric period. Therefore, anxiety management can be effective for women to cope with menopausal symptoms. Carl Gustav Jung, a Swiss psychiatrist, discovered the therapeutic effect of coloring mandala, which is one of the art therapy methods in reducing anxiety. When the studies are examined, there have been many studies investigating the effect of Mandala coloring on reducing anxiety. Curry and Kasser (2005), Van der Vennet and Serice (2012), Flet et al (2017) stated that coloring mandala reduces anxiety on students; Gürcan and Atay Turhan (2021) and Yakar et al (2021) found that it reduces anxiety and depression in cancer patients; Khademi et al (2021) reported that it reduced anxiety in hospitalized covid-19 patients; Amelia et al (2020) found that it reduced anxiety in pregnant women. When the studies are examined, there are studies showing that coloring mandala reduces anxiety in cancer patients, children, and pregnant women, but no study has been found on the effect of reducing anxiety related to menopausal symptoms and improving the quality of life of women in the climacteric period. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Climactericum
Keywords
Climacterium, Anxiety, Quality of life, Mandala coloring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mandala coloring group
Arm Type
Experimental
Arm Description
Mandala painting will be applied to climacteric women with anxiety.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety symptoms
Intervention Type
Other
Intervention Name(s)
Mandala coloring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Introductory Information Form
Description
A form that includes questions about women's socio-demographic and menopausal and characteristics.
Time Frame
between one to six months
Secondary Outcome Measure Information:
Title
the Spielberger State-Trait Anxiety Inventory (STAI) Scale
Description
This scale, developed by Spielberg in 1973, consists of 20 questions. It is a 4-point Likert type scale (1=not at all, 4=very much). The lowest score that can be obtained from the scale is 20, and the highest score is 80. The higher the score is, the higher the anxiety level is. The alpha value of the scale is 0.86-.92.33. The validity and reliability study in our country was conducted by Oner et al., in 1983 and the alpha value was found between 0,83 and 0,87. The scale that will be used to evaluate the state and trait anxiety of pregnant women. As the score increases, it is determined that the anxiety is higher.
Time Frame
between one to six months
Other Pre-specified Outcome Measures:
Title
Menopause-Specific Quality of Life Questionnaire
Description
This scale was developed by Hilditch, Lewis et al. in 1996 to create a health-specific quality of life scale in menopause with psychometric properties based on women's experiences. It was adapted to Turkish society by Kharbouch and Sahin in 2005 and its validity and reliability were determined. It consists of 29 questions and each sub-domain score is ordered from 1 to 8. As the score increases, the severity of the complaint also increases.
Time Frame
between one to six months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Efsun DERIN
Phone
+90546901799
Email
efsunderinn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayça ŞOLT KIRCA
Phone
+905392684185
Email
aycasolt@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayça ŞOLT KIRCA
Organizational Affiliation
Kırklareli University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Efsun DERIN
Organizational Affiliation
Kırklareli University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ELIF DAGLI
Organizational Affiliation
Cukurova University
Official's Role
Study Director
Facility Information:
Facility Name
Kırklareli Training and Research Hospital
City
Kırklareli
State/Province
Centre
ZIP/Postal Code
39000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efsun Derin

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period

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