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临床试验/NCT03821207
NCT03821207已完成不适用

The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain

研究概览

简要总结

The study will planing to determine the advantages of abdominal massage and exercise on primary dysmenorrhea in university students, and to evaluate whether one of these applications is superior to the other.

详细描述

The students included in the study will be randomly separated into 3 groups using a computer-based randomisation plan (www.randomization.com).

Those included in the massage group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle. The massage is to be applied as effleurage (light touch) clockwise over the abdomen from over the abdominal wall to the intestinal area.

The students in the exercise group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle.

The control group will perform no exercise or massage. The applications will be demonstrated to the participants by a physiotherapist. Throughout the study period, the students will be followed up to ensure that the applications are being made. Follow-up of the applications of abdominal massage and stretching exercises applied by there searcher physiotherapist according to the study plan will be conducted by the researchers.

The participants will be informed how to apply the massage and perform the exercises and that these applications will cause no side-effects. They will also be informed that participation in the study is voluntary and they can withdraw from the study at any time.

研究设计

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

入排标准

年龄范围
18 Years 至 20 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Regular menstrual cycles Record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3 menstrual cycles Not use analgesics during the study period

排除标准

  • Endometriosis Pelvic inflammatory disease Ovarian cyst Myoma Chronic pelvic pain Urinary system infection Menometrorrhagia Obstructive vaginal or uterine congenital anomalies Secondary dysmenorrhea A history of major abdominal or pelvic surgery in the last 3 months Hormonal treatment in the last 6 months.

研究组 & 干预措施

The exercise group

Active Comparator

The group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle

干预措施: The exercise group (Behavioral)

The abdominal massage group

Active Comparator

The group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle.The massage is to be applied as effleurage (light touch) clockwise over the abdomen

干预措施: The abdominal massage group (Behavioral)

The control group

Placebo Comparator

The control group will perform no exercise or massage.

干预措施: Control Group (Behavioral)

结局指标

主要结局

The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain

时间窗: 6 month

Visuale Analogue Scale will be used to measure pain level at 3 menstrual cycle. The change from baseline in Visual Analog Scale at 3 menstrual cycle will be measured in the studied groups

The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.

时间窗: 6 month

Dysmenorrhea Symptom List will be used to measure degree of dysmenorrhea symptoms at 3 menstrual cycle. The findings seen in the presence of dysmenorrhea in females during 3 menstrual cycle will be measured by decrease at severity of scores belong to Dysmenorrhea Symptom List.

次要结局

  • The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding(6 month)

研究者

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

Meryem Kurek eken

Associated Proffesor

Aydin Adnan Menderes University

研究点 (2)

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