Clinical trial NCT05575349: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Climactericum
Keywords: Climacterium
Anxiety
Quality of life
Mandala coloring
Lead sponsor: Kırklareli University
Sponsor class: OTHER
Collaborators: name: Cukurova University
First posted: 2022-10-12
Enrollment: 80
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Introductory Information Form
timeFrame: between one to six months
Secondary outcomes:
measure: the Spielberger State-Trait Anxiety Inventory (STAI) Scale
timeFrame: between one to six months
Other outcomes:
measure: Menopause-Specific Quality of Life Questionnaire
timeFrame: between one to six months
Locations:
city: Kırklareli
country: Turkey
facility: Kırklareli Training and Research Hospital
state: Centre
Study officials:
affiliation: Kırklareli University
name: Ayça ŞOLT KIRCA
role: PRINCIPAL_INVESTIGATOR
affiliation: Kırklareli University
name: Efsun DERIN
role: STUDY_DIRECTOR
affiliation: Cukurova University
name: ELIF DAGLI
role: STUDY_DIRECTOR
References: