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临床试验/NCT06499259
NCT06499259已完成不适用

The Effect of Mandala Coloring Activity on Stress and Anxiety in Mothers With Babies in the Neonatal Intensive Care Unit: A Randomized Controlled Study

Istanbul Medeniyet University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

The aim of this study was to evaluate the effect of mandala painting activity on stress and anxiety levels in mothers whose babies were hospitalized in the neonatal intensive care unit (NICU).

详细描述

The health status of the baby and the duration of stay in the intensive care unit cause the mother to experience varying levels of stress and anxiety. It is very important to determine the levels of stress and anxiety in mothers of newborns hospitalized in the Neonatal Intensive Care Unit and to take interventions to reduce it. This study will be conducted to evaluate the effect of mandala coloring activity on stress and anxiety levels in mothers whose babies are hospitalized in the neonatal intensive care unit. It is thought to make an important contribution to the field because it will be a randomized controlled study on the effect of mandala painting activity on stress and anxiety in mothers whose babies are hospitalized in the neonatal intensive care unit.

Type of study: The study was planned as a randomized controlled experimental study.

In the G*Power program, it was determined that it would be sufficient to include 30 participants in the study groups with a 5% alpha margin of error, 0.95 confidence interval, 0.95 effect size and 0.95 power. Considering the randomization list and possible losses, the sample size was increased by 20% and it was decided to include 72 mothers in the study, each group consisting of 36 participants.

Data Collection: Before starting the study, the purpose of the study will be explained to the participant by the researcher and informed consent will be obtained. Data collection tools will be applied to the mothers in the experimental group and the mandala painting activity will begin. The mandala painting program will consist of a total of 7 mandala painting sessions with 40-minute sessions every day for 7 days. The researcher will accompany the first mandala painting activity. She will answer the participant's questions. The mother will do the remaining 6 mandala coloring sessions alone every day; at the end of the 6 days, the researcher will reapply the data collection tools. The mothers in the control group will not receive any treatment within the scope of the study. When they are included in the study, data collection forms will be applied as the first measurement; at the end of 7 days, the same mothers will fill out the data collection forms again as the last measurement. After the completion of the data collection forms, the mothers in the control group will be given a mandala package consisting of 7 applications.

H0: Mandala coloring activity has no effect on stress and anxiety in mothers whose infants are hospitalized in the neonatal intensive care unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Stratified and block randomization method will be used in the randomization scheme of the study. In the study, maternal age, number of pregnancies, duration of intensive care unit stay and gestational age variables will be used in the stratification of newborns.

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers whose baby has been in the neonatal intensive care unit for at least 3 days and staying in the mother's hotel,
  • Having agreed to participate in the research/approved the informed consent form
  • No visual or hearing impairment
  • Being over 18 years old,
  • Being at least literate
  • The absence of any problem that would prevent him/her from painting mandala (no problem in his arm or hand that would prevent his movement)
  • Must not have a diagnosis of mental illness/anxiety disorder

排除标准

  • Mothers with communication and perception problems will not be included in the study.
  • Mothers with comprehension and speech problems will not be included in the study.
  • Mothers with psychiatric illness and taking medication will not be included in the study.

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: After the 7th mandala painting session (7 days after the first session) (post-test)

Visual Analog Scale in the assessment of perceived stress. The use of VAS to assess stress is as discriminative as questionnaires and has construct validity. The VAS used consists of a small dotted ruler with endpoints labeled "no stress" and "maximum stress". Between these two extremes, how much stress is experienced is determined by the VAS. This scale gives a single subjective stress score between 0 and 10.

次要结局

  • State Trait Anxiety Inventory (STAI)(After the 7th mandala painting session (7 days after the first session) (post-test))

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aynur Aytekin Ozdemir

Prof. Dr.

Istanbul Medeniyet University

研究点 (2)

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