Clinical trial NCT06804018: Mandala Colouring: Its Impact on Well-Being, Self-Compassion, and Anxiety in Primiparous Pregnancies
Official title: The Effect of Mandala Colouring Practice on Pregnancy Well-Being, Self-Compassion and Anxiety in Primiparous Pregnant Women: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Women Health
Well Being
Self Compassion
Anxiety
Keywords: Pregnant women
anxiety
well being
self compassion
mandala coloring
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2025-01-31
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Maintaining well-being during pregnancy, reducing anxiety and supporting self-compassion are critical for the health of expectant mothers and the development of the baby. In addition to traditional medicine, alternative therapeutic approaches have been increasingly popular in recent years as a supportive approach during pregnancy. Among these alternative methods, creative activities such as mandala painting have the potential to reduce stress, increase mental focus and provide emotional balance.

H1: There is a difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.

H0: There is no difference in well-being, self-compassion and anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.

Sub-Hypotheses of the Study:

H1-1: There is a difference in well-being between primiparous pregnant women who painted mandalas and those who did not during pregnancy.

H1-2: There is a difference in self-compassion levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.

H1-3: There is a difference in anxiety levels between primiparous pregnant women who painted mandalas and those who did not during pregnancy.

Detailed description: Maintaining well-being, reducing anxiety, and supporting self-compassion during pregnancy are of critical importance for the health of expectant mothers and the development of the baby. In addition to traditional medicine, the use of alternative therapeutic approaches as a support during pregnancy has been increasingly gaining interest in recent years. Among these alternative methods, creative activities such as mandala painting have the potential to reduce stress, increase mental focus, and provide emotional balance (Babouchkina and Robbins, 2015; Stinley et al., 2015; Sandmire et al., 2016; Mo and Ko, 2023; Chen et al., 2024; Şolt Kırca and Dağlı, 2024). However, controlled studies evaluating the effects of mandala painting during pregnancy are limited (Şolt Kırca and Dağlı, 2024). In particular, it seems that the effects of mandala painting on psychological well-being, self-compassion, and anxiety levels in primiparous pregnant women and in the last trimester of pregnancy have not been systematically examined. With these effects, it is thought that mandala painting during pregnancy will be used as a stress management tool recommended by health professionals and will contribute to the field as it can contribute to the emotional well-being of future pregnant women.

Data Collection Tools In collecting the data of the research:

The research data will be collected using the Sociodemographic Characteristics Form, State Anxiety Scale, Pregnancy Well-Being Scale and Self-Compassion Scale Short Form. Sociodemographic Characteristics Form: The form consists of 6 questions in total and includes age, education level, employment status, perceived economic status, number of pregnancies and whether the pregnancy was planned. State Anxiety Scale: The State-Trait Anxiety Inventory (STAI) form developed by Spielberger (1983) is used for adults between the ages of 18-69 and consists of 20 items (state anxiety) measuring the intensity of anxiety as an emotional state (Spielberg, 1983). In order for pregnant women to express their own feelings, they can instantly mark how they feel without spending too much time on any expression, and it is evaluated as 1: not at all, 2: a little, 3: a lot and 4: completely. If no response is given to more than three statements, the completed form is considered invalid and is not scored. Direct statements express negative emotions; reversed statements express positive emotions. When scoring, those with a weight value of 1 are converted to 4, and those with a weight value of 4 are converted to 1. There are ten reverse-coded statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. Theoretically, the scores obtained vary between 20 and 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety (Spielberg, 1983). The scale was adapted to Turkish culture by Öner and Le Compte, and a reliability-validity study was conducted. In the Turkish version of the scale, reliability coefficients determined by Cronbach's alpha correlations were found to be between 0.83 and 0.92 (Öner and Le Compte, 1983). Well-Being Scale in Pregnancy: The Turkish validity-reliability study of the scale developed by Alderdice et al. (2015) in 2015 was conducted by Sunay et al. (2022). The Cronbach's alpha reliability coefficient in the original scale is 0.73 (Alderdice et al., 2015). The scale defines the characteristics of well-being measurement during pregnancy and general well-being gives women the opportunity to express their positive and negative feelings and thoughts about their pregnancy. The scale is a six-point Likert-type scale and the responses to the items are scored as "1 = always", "2 = most of the time", "3 = more than half of my time", "4 = less than half of my time", "5 = sometimes", "6 = never". The increase in the average score obtained from the scale indicates that well-being during pregnancy has increased. The scale consists of a total of 12 items and has two subscales: "Positive Affect and Satisfaction" and "Concerns". The Positive Affect and Satisfaction subscale (high scores indicate high positive emotions, positive relationships, and satisfaction with pregnancy and care) consists of 7 items (items 1, 2, 3, 5, 7, 11, and 12). The Concerns subscale (where high scores indicate less anxiety) consists of 5 items (items 4, 6, 8, 9, and 10). The 5 items of the Concerns subscale (items 4, 6, 8, 9, and 10) are calculated by reversing them. The Cronbach's alpha value of the scale was found to be 0.73. The Positive Affect and Satisfaction subscale of the scale was found to be 0.71, and the Concerns subscale was found to be 0.70 (Sunay et al., 2022). Self-Compassion Scale Short Form: The scale developed by Neff (2003) was converted into a short form by Raes, Pommier, Neff, and Van Gucht (2011). The form, whose Turkish validity and reliability study was conducted by Yıldırım and Sarı (2018), consists of a total of 11 questions. It is one-dimensional. The Likert-type scale is marked as 1: never, 2: rarely, 3: sometimes, 4: often, and 5: always. Items 1, 4, 8, 9, 10, and 11 of the scale are reverse-coded. The internal consistency coefficient of the scale was calculated as 0.75. The total scores obtained from the scale indicate that the self-compassion level of the individuals is high (Neff et al., 2003; Yıldırım and Sarı, 2018).

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-35
* Being in the last three months of pregnancy (Amelia et al., 2020)
* Getting a State Anxiety Inventory (STAI) score of ≥40
* Having a smartphone and internet connection
* Being willing to participate in the study
* Being spontaneously pregnant
* Not having a diagnosed health risk (diabetes, preeclampsia, fetal anomaly, etc.) in the mother or fetus

Exclusion Criteria:

* Those who do not meet the Inclusion Criteria

Primary outcomes:
measure: Anxiety Scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Well-being
timeFrame: 5 weeks
Other outcomes:
measure: Self-Compassion
timeFrame: 5 weeks
Locations:
city: Erbaa
country: Turkey
facility: Tokat Gaziosmanpasa University
state: Tokat
Study officials:
References: