Evaluation of the Effects of Nada Yoga Music and Mandala Coloring During Childbirth on Pain, Anxiety, Labor Process, and Maternal Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Personal Information Form
研究概览
简要总结
Aim:
The aim of this study is to evaluate the effect of mandala coloring on labor pain, childbirth experience, and maternal satisfaction in pregnant women.
Materials and Methods:
This study was conducted as a randomized controlled trial with a pretest-post test group design including measurements at multiple time points. The study population consisted of pregnant women admitted for vaginal delivery to the labor unit of a hospital between June 1, 2025, and May 1, 2026. Sample size was calculated using the G*Power 3.1.9.7 program. In the sample size calculation, the Cohen's d = 0.80 value obtained from the reference study was used as the basis and was converted to an approximate effect size of f = 0.40. Analysis performed with a 5% significance level and 80% statistical power indicated that the required minimum sample size for the three groups was 66 participants in total. To prevent potential data loss, support voluntary participation, and increase statistical power, 36 participants were initially planned for each group; however, because one participant in each intervention group was younger than 18 years of age and was therefore excluded, the study was completed with a total of 106 participants in the mandala coloring (n = 35), Nada Yoga music (n = 35), and control (n = 36) groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •No communication barriers
- •Pregnant women admitted to Ağrı Training and Research Hospital for vaginal delivery
- •Willingness to participate in the study
- •No contraindication to normal vaginal delivery (e.g., cephalopelvic disproportion)
- •Term pregnancy (38-42 weeks of gestation)
- •Absence of any chronic disease (e.g., diabetes, hypertension)
- •No condition preventing mandala coloring (e.g., hand or finger injuries, structural impairments)
- •No condition preventing listening to music (e.g., hearing impairment)
排除标准
- •Pregnant women who prefer cesarean delivery despite having no contraindication to vaginal birth
- •Failure to respond to the questionnaire items
- •Presence of psychiatric disorders (e.g., social phobia, schizophrenia, bipolar disorder)
- •Conditions requiring emergency cesarean section during the first stage of labor
研究组 & 干预措施
MANDALA
Mandala coloring
干预措施: MANDALA (Other)
NADA+MANDALA
Mandala coloring + Nada Yoga music
干预措施: MANDALA + NADA (Other)
CONTROL
Control
NADA
Nada Yoga music
干预措施: NADA (Other)
结局指标
主要结局
Personal Information Form
时间窗: Baseline
This form was developed by the researchers based on the relevant literature to collect data on the participants' sociodemographic characteristics.
State Anxiety Inventory (SAI)
时间窗: Baseline, Periprocedural (labor stages: first, second, third)
The State Anxiety Inventory (SAI) was developed by Spielberger et al. in 1964 to assess the state anxiety levels of both normal and clinical populations. The scale was adapted into Turkish by Öner and Le Compte (1983). It is a self-report instrument consisting of short statements. The State Anxiety Inventory is designed to measure how an individual feels at a particular moment and under specific conditions. It consists of 20 items that assess the individual's current level of anxiety. Responses are rated on a 4-point Likert scale based on the intensity of the expressed feelings or behaviors: (1) not at all, (2) somewhat, (3) moderately so, and (4) very much so. The inventory includes 10 reverse-coded items (items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20). The total state anxiety score is calculated by subtracting the sum of reverse-coded items from the sum of directly scored items and adding a constant value of 50. The total scores range theoretically
Labor Process Evaluation Form
时间窗: Periprocedural (labor stages: first, second, third)
The Labor Process Evaluation Form (Appendix 5) is a tool developed by the researcher based on the relevant literature (Tuncay, 2024) to assess the childbirth process of the participants.
Visual Analog Scale (VAS)
时间窗: Baseline, Periprocedural (labor stages: first, second, third)
The Visual Analog Scale (VAS) is It is a unidimensional measurement tool used to evaluate labor pain intensity. Pain level is determined by measuring the point marked by the participant on a 10-cm line ranging from 0 (no pain) to 10 (unbearable pain). Higher scores indicate more severe pain perception. The VAS is widely used as a valid and reliable method for the quantitative evaluation of pain perception, particularly in pregnant women and women during labor
Birth Satisfaction Scale-Short Form (BSS-S)
时间窗: Baseline, Periprocedural (labor stages: first, second, third)
The Birth Satisfaction Scale-Short Form (BSS-S) This scale, developed by Martin and Fleming and revised by Martin and Martin, is a 10-item, 5-point Likert-type instrument designed to evaluate women's perceptions of childbirth. The Turkish validity and reliability study was conducted by Göncü and Karahan. Scores obtained from the scale range from 0 to 40, with higher scores indicating greater satisfaction; in the Turkish adaptation, scores were classified as low (\<13), moderate (14-27), and high (≥28) satisfaction. Items are scored between 0 and 4, and items 2, 4, 7, and 8 are reverse coded. Although the original scale included three subdimensions, the Turkish validity study identified two subdimensions with eigenvalues above 1: Personal Attributes \& Stress (PAS) and Quality of Care (QC).
State Anxiety Inventory (SAI-I)
时间窗: Baseline, Periprocedural (labor stages: first, second, third)
The State Anxiety Inventory (SAI-I) It was developed to evaluate anxiety level at a specific moment. The scale was adapted into Turkish by Öner and Le Compte. The scale is a self-report instrument that evaluates the individual's current emotional state. It consists of a total of 20 items, and items are scored on a 4-point Likert scale (not at all = 1, somewhat = 2, very much = 3, completely = 4). Obtained scores range from 20 to 80, with higher scores indicating higher anxiety levels.
Labor Process Evaluation Form (LPEF)
时间窗: Periprocedural (labor stages: third)
Labor Process Evaluation Form (LPEF): It was prepared by the researcher in accordance with the literature to evaluate clinical and experiential characteristics associated with the labor process in the participants. The form includes labor stages, labor duration, and basic clinical findings related to the mother and newborn
次要结局
未报告次要终点
研究者
NURTEN ÖZÇALKAP
Asistant Professor
Agri Ibrahim Cecen University