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NCT Number: NCT05575349

Effects of Mandala Coloring on Anxiety and 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.

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Key information

Age range

42 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kırklareli Training and Research Hospital

Kırklareli, Centre, 39000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandala coloring

Other

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 outcomes

  1. Introductory Information Form

    Time frame: between one to six months

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

Secondary outcomes

  1. the Spielberger State-Trait Anxiety Inventory (STAI) Scale

    Time frame: between one to six months

    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.

Other outcomes

  1. Menopause-Specific Quality of Life Questionnaire

    Time frame: between one to six months

    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.

Sponsors and collaborators

Lead sponsor

Kırklareli University

Other

Collaborators

  • Cukurova University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2022
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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