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

Anxiety Clinical Trial

Official title:

Effects of Mandala Coloring on Anxiety and Quality of Life of Women in the Climacteric Period: Randomized Controlled Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05575349
• Other study ID #: KirklareliED-1
• Status: Completed
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Kirklareli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2023
• Est. primary completion date: June 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 42 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Mandala coloring
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.

Locations

Country	Name	City	State
Turkey	Kirklareli Training and Research Hospital	Kirklareli	Centre

Sponsors (2)

Lead Sponsor	Collaborator
Kirklareli University	Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Menopause-Specific Quality of Life Questionnaire	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.	between one to six months
Primary	Introductory Information Form	A form that includes questions about women's socio-demographic and menopausal and characteristics.	between one to six months
Secondary	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.	between one to six months