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临床试验/NCT04572555
NCT04572555已完成不适用

The Effects of Heat Application on Depression, Anxiety, Menstrual Attitude and Severity of Dysmenorrhea at 4 Menstrual Cycle

Balikesir University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月1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
20
试验地点
2
主要终点
severity of dysmenorrhea assessed by Visual Analogue Scale

研究概览

简要总结

AIM: Establishing the effects of heat application on depression, anxiety, menstrual attitude and severity of dysmenorrhea.

METHODS: This randomized controlled prospective experimental trial was conducted with 43 students who were suffering from dysmenorrhea under 2 groups, the heat treatment group (n=20) and the control group (n=23). To the heat treatment group, dry heat was applied for 20 minutes to the lower abdominal region of the subjects when their dysmenorrhea was most severe. The control group did not receive any treatments. The data were acquired by using a Personal Information Form. The Visual Analogue Scale (VAS) for determining the severity of dysmenorrhea, the Short Form McGill Pain Questionnaire to establish the type of pain, the Menstrual Attitude Questionnaire to establish the attitude and the practices during dysmenorrhea and the Depression Anxiety and Stress Scale to determine the psychological impacts of dysmenorrhea were used. In the first menstrual cycle, both groups received the questionnaires, and no treatment was applied. At the second, third and fourth menstrual cycles, VAS and the McGill Pain Questionnaire were applied before the treatment (T1), right after the treatment (T2) and 2 hours after the treatment (T3). The Menstrual Attitude Questionnaire and the Depression Anxiety and Stress Scale were applied right after the treatment.

详细描述

This experimental randomized controlled prospective study was conducted at the tocology department of a university hospital in Balikesir, Turkey between March 2019 and June 2019.

The sample size was determined using G * Power 3 calculations in accordance with prior studies on heat application to the lower abdomen. Estimation of the effects was acquired from the findings of Potur and Kömürcü (2014), who reported a pain severity of 1.99 ± 2.42 in the heat-treated group and 5.78 ± 2.63 in the control group. We aimed to establish a similar difference. For each group, the sample count was determined as 12. However, in order to increase the power of the study, 23 students were included both in the heat treatment group and the control group, totaling up to 46 individuals for the sample. Power analysis indicated that the size of the sample had a power of 96% with α = 0.05. The decrease comparative to the control group in the severity of dysmenorrhea pain after heat application had an effect size of 0.616.

The inclusion criteria were determined as being at the ages of 18-30, being nulliparous, having a VAS score of 2 and higher [24], not having a systemic or chronic disease and not using hormonal contraceptives. The exclusion criteria were determined as using forms of analgesic and alternative treatments during the study (1 subject in the heat treatment group was excluded at the 3rd menstrual cycle) and experiencing menstrual irregularities (3 subjects in the heat treatment group and 4 subjects in the control group were excluded at the 3rd menstrual cycle).

To the sample of the study, students with dysmenorrhea pain were admitted. Randomization was achieved by having the subjects pull envelopes for the designation of their groups. Students who pulled the 'Heat Treatment Group' were allocated to the heat treatment group, and the students who pulled the 'Control Group' were allocated to the control group. A total of 46 students partook in the study, and 3 students from the heat treatment group were excluded from the study by their own requests. At the 1st and the 2nd menstrual cycles, the heat treatment group consisted of 20 subjects, and the control group consisted of 23. At the 3rd menstrual cycle, 4 subjects from the heat treatment group and 4 subjects from the control group were excluded from the study in accounts of their analgesic medicine usage or inability to menstruate. At the 3rd and 4th menstrual cycles, the heat treatment group had 16 subjects, and the control group had 19.

For the collection of the data, Personal Information Forms were developed by the researchers in accordance with the scientific literature, the Visual Analogue Scale (VAS) in order to establish the severity of the dysmenorrhea pain, the Short Form McGill Pain Questionnaire to determine the types of pain, the Menstrual Attitude Questionnaire to establish the attitudes and the behaviors during menstruation and the Depression Anxiety and Stress Scale to determine the psychological effects of dysmenorrhea were utilized. The Personal Information Form was applied to the heat treatment group and the control group after receiving permission from the subjects. The subjects were observed for a total of 4 menstrual cycles. The subjects in the heat treatment group and the control group were instructed not to use any analgesic medication or alternative treatments during the study. In the 1st menstrual cycle, heat treatment was not applied to the subjects. In the first menstrual cycle, the Short Form McGill Pain Questionnaire, VAS, the Menstrual Attitude Questionnaire and the Depression Anxiety and Stress Scale was applied at the peak severity of dysmenorrhea pain. In the following 3 menstruation cycles, VAS-T1 and the Short Form McGill Pain Questionnaire-T1 were applied to the heat treatment group and the control group at the peak severity of dysmenorrhea pain. Later, 20 minutes of heat treatment was applied to the heat treatment group. The control group were not given any treatments. VAS-T2, the Short Form McGill Pain Questionnaire-T2, the Menstrual Attitude Questionnaire and the Depression Anxiety and Stress scale were applied to the subjects in both groups 20 minutes after the primary evaluation. VAS-T3 and the Short Form McGill Pain Questionnaire were applied to both groups 2 hours after the primary evaluation.

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)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • the ages of 18-30,
  • being nulliparous,
  • having a VAS score of 2 and higher,
  • not having a systemic or chronic disease
  • not using hormonal contraceptives.

排除标准

  • using forms of analgesic and alternative treatments during the study
  • experiencing menstrual irregularities

结局指标

主要结局

severity of dysmenorrhea assessed by Visual Analogue Scale

时间窗: Change from Baseline severity of dysmenorrhea at 4 months

Dysmenorrhea level, Visual Analog Scale The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end

次要结局

  • Rate of Depression, Anxiety and Stress at Menstrual Cycle(İmmediately after the intervention at 4 Menstrual Cycle)
  • Rate of Menstrual Attitudes at Menstrual Cycle(İmmediately after the intervention at 4 Menstrual Cycle)

研究者

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

Hülya TÜRKMEN

Lecturer (PhD)

Balikesir University

研究点 (2)

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