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临床试验/NCT07407907
NCT07407907进行中(未招募)不适用

The Effect of the Education Provided Based on the Information-Motivation-Behavioral Skills Model in Women Experiencing Hot Flashes During Menopause

Marmara University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月7日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Hot Flash-Related Daily Interference

研究概览

简要总结

This study was conducted to examine the effect of an education program based on the Information-Motivation-Behavioral Skills (IMB) Model on the level of hot flashes, overall menopausal symptoms, and quality of life in women experiencing hot flashes during the menopausal period.

The study consisted of an intervention group and a control group. The intervention group received a structured education program based on the IMB Model, while no education, counseling, or care intervention was provided to the control group. Both groups were assessed at baseline, and at the 1st and 3rd months following the intervention.

It is expected that the findings obtained from this study will demonstrate the effectiveness of IMB Model-based education in the management of menopausal vasomotor symptoms and contribute to the development of evidence-based nursing practices for women during the menopausal period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
44 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between 44 and 60 years.
  • Women in the perimenopausal or postmenopausal period.
  • A score of ≥ 10 on the Menopause-Specific Hot Flash Scale.
  • No diagnosis of severe chronic disease and no regular medication use related to such conditions.
  • Not receiving Hormone Replacement Therapy (HRT).
  • No diagnosed mental disorder requiring medical treatment.
  • Able to read, write, speak, and understand Turkish, with no language barriers.
  • Willingness to participate in the study and provision of voluntary informed consent.

排除标准

  • Not meeting the inclusion criteria.
  • Initiation of Hormone Replacement Therapy during the study period.
  • Refusal to participate in the study.
  • Occurrence of an unexpected acute illness during the study period.
  • Withdrawal from the study at any stage by personal choice.
  • Incomplete completion of study questionnaires or forms after enrollment.

研究组 & 干预措施

IMB Model-Based Education Group

Experimental

A structured education program based on the Information-Motivation-Behavioral Skills (IMB) model was provided to women experiencing hot flashes during the menopausal period. The education program included information on the physiology of hot flashes, symptom management, lifestyle modifications, coping strategies, and the development of behavioral skills to manage menopausal symptoms.

干预措施: IMB Model-Based Education Program (Behavioral)

Control Group (No Education)

No Intervention

This group consisted of women experiencing hot flashes during the menopausal period who did not receive any education or intervention during the study period. Participants continued their usual daily routines.

结局指标

主要结局

Hot Flash-Related Daily Interference

时间窗: Baseline (pre-intervention), 1 month, and 3 months

Hot flash-related daily interference was assessed using the Hot Flash Related Daily Interference Scale, which evaluates the extent to which hot flashes interfere with daily activities and quality of life.

次要结局

  • Hot Flush Beliefs(Baseline (pre-intervention), 1 month, and 3 months)
  • Menopause-Specific Quality of Life(Baseline (pre-intervention), 1 month, and 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeliz ILDIR ALTUN

Lecturer

Marmara University

研究点 (1)

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