The Effect of Spinal Stabilization Training in Women With Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS):
研究概览
简要总结
The study, designed as a randomized controlled experimental trial, was conducted at Tonya Vocational School. Institutional approval was obtained to carry out the study at Tonya Vocational School (Appendix-). Participants who met the inclusion and exclusion criteria and voluntarily agreed to participate were required to sign an informed consent form prior to the initiation of the study. Following the acquisition of informed consent, 50 women with dysmenorrhea, identified based on the WaLIDD score, were randomly allocated into two groups using a simple randomization method (sealed envelope): 25 participants in the experimental group and 25 in the control group.Baseline assessments were performed by the same researcher within the first week immediately following the most recent menstrual period, prior to the commencement of the intervention. Participants' demographic characteristics and menstrual cycle information were recorded using a data collection form before the exercise intervention.
Pain intensity was evaluated using the Visual Analog Scale (VAS); menstrual symptom severity using the Menstrual Symptom Scale; body awareness using the Body Awareness Questionnaire; muscle endurance using the McGill trunk endurance tests; lumbopelvic mobility using the Modified Schober test; activities of daily living using the Lawton-Brody Instrumental Activities of Daily Living Scale; problem-solving skills using the Problem Solving Inventory; decision-making styles using the Melbourne Decision Making Questionnaire; quality of life using the SF-12 questionnaire; and physical activity levels using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). All measurements were conducted within the first week immediately following the most recent menstrual period, both before (baseline assessment) and after (post-intervention assessment) the exercise program.
详细描述
The study, designed as a randomized controlled experimental trial, was conducted at Tonya Vocational School. Institutional approval was obtained to carry out the study at Tonya Vocational School (Appendix-). Participants who met the inclusion and exclusion criteria and voluntarily agreed to participate were required to sign an informed consent form prior to the initiation of the study. Following the acquisition of informed consent, 50 women with dysmenorrhea, identified based on the WaLIDD score, were randomly allocated into two groups using a simple randomization method (sealed envelope): 25 participants in the experimental group and 25 in the control group.Baseline assessments were performed by the same researcher within the first week immediately following the most recent menstrual period, prior to the commencement of the intervention. Participants' demographic characteristics and menstrual cycle information were recorded using a data collection form before the exercise intervention.
Pain intensity was evaluated using the Visual Analog Scale (VAS); menstrual symptom severity using the Menstrual Symptom Scale; body awareness using the Body Awareness Questionnaire; muscle endurance using the McGill trunk endurance tests; lumbopelvic mobility using the Modified Schober test; activities of daily living using the Lawton-Brody Instrumental Activities of Daily Living Scale; problem-solving skills using the Problem Solving Inventory; decision-making styles using the Melbourne Decision Making Questionnaire; quality of life using the SF-12 questionnaire; and physical activity levels using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). All measurements were conducted within the first week immediately following the most recent menstrual period, both before (baseline assessment) and after (post-intervention assessment) the exercise program.
The control group was provided with relaxation exercises and lifestyle recommendations, including avoidance of exposure to environmental tobacco smoke; reduction or cessation of smoking and alcohol consumption; limitation of the intake of caffeine, sugar, cold foods and beverages, and high-salt foods; preference for loose and cotton clothing; taking warm standing showers; and maintaining adequate and good-quality sleep (at least 6-8 hours). These recommendations were delivered to the control group .In addition to relaxation exercises and lifestyle recommendations, the experimental group received spinal stabilization training. A total of 16 sessions of spinal stabilization training were administered under the supervision of a physiotherapist, with two sessions per week over an 8-week period. Each session lasted approximately 45-50 minutes. The exercise program began with a 5-6 minute warm-up, followed by a 35-40 minute main program, and concluded with a 5-6 minute cool-down period. The warm-up and cool-down phases consisted of general stretching exercises and light jogging.The exercise program was designed to be progressive; accordingly, during the first week, participants performed a single set of 6-10 repetitions for each exercise. The number of repetitions and sets was increased every two weeks based on the participants' capacity. Progression in the exercise program was achieved by increasing the number of repetitions and sets, adding resistance, and extending the duration. The level of exertion was determined using the Borg Scale (6-20), and the exercise intensity was increased when participants reached a Borg rating of 11-14.
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
- 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
- 否
入选标准
- •Being between 18 and 30 years of age
- •Having no history of childbirth
- •Being cooperative and oriented
- •Having a regular menstrual cycle (28 ± 7 days)
- •Scoring >1 on the WaLIDD scale
- •Reporting a menstrual pain score greater than 4 out of 10 on the Visual 7)Analog Scale (VAS)
- •Volunteering to participate in the study
排除标准
- •Using hormonal contraceptive medications or an intrauterine device (IUD)
- •Having any mental, cardiovascular, pulmonary, or orthopedic condition that could limit exercise participation
- •Being pregnant
结局指标
主要结局
Visual Analog Scale (VAS):
时间窗: "Baseline and Week 8
Pain intensity was assessed using the VAS. Participants indicated the severity of pain by marking an "x" on a 10-cm line, with each centimeter representing one unit. A score of "0" indicated no pain, while a score of "10" represented the most severe pain.
Menstruation Symptom Scale
时间窗: "Baseline and Week 8
This scale was used to evaluate menstrual symptoms. The questionnaire consists of 22 items, including 19 items assessing symptoms (emotional, physical, and pain-related) and 3 items evaluating coping strategies for symptoms. Higher total scores indicate more severe menstrual symptoms. The Turkish validity and reliability study of the scale was conducted by Gülten Güvenç.Minimum score: 22, Maximum score:110.
McGill Trunk Endurance Tests:
时间窗: Baseline and Week 8
Lumbopelvic muscle endurance was assessed using the McGill trunk endurance tests , which include trunk flexion, extension, and lateral flexion (right and left) endurance assessments. The testing positions were demonstrated and explained to participants in advance. Participants were then asked to repeat each position once to familiarize themselves with the assessment postures. Participants were encouraged to maintain each isometric position for as long as possible for each test. The duration for which individuals were able to maintain the correct posture was recorded in seconds . The McGill trunk endurance tests were terminated when the test position deteriorated or when participants indicated that they could no longer continue the test.
Modified Schober Test:
时间窗: Baseline and Week 8
This test was used to assess lumbopelvic mobility. It is a method that measures lumbar spinal mobility during flexion and extension movements . For the measurement, the line between both posterior superior iliac spines was first marked, and points 10 cm above and 5 cm below this mark were identified. Participants were then asked to bend forward. The difference between the initial and final measurements was recorded in centimeters. In this test, a 0-5 cm difference indicates reduced flexion flexibility, a difference greater than 10 cm indicates increased flexibility, and values between 5-10 cm are considered normal.
次要结局
- Problem Solving Inventory:(Baseline and Week 8)
- Melbourne Decision Making Questionnaire:(Baseline and Week 8)
- Short Form Health Survey (SF-12):(Baseline and Week 8)
- Body Awareness Questionnaire:(Baseline and Week 8)
- Lawton-Brody Instrumental Activities of Daily Living Scale(Baseline and Week 8)
- International Physical Activity Questionnaire - Short Form (IPAQ-SF):(Baseline and Week 8)
研究者
Sevtap Günay
Prof
Izmir Katip Celebi University
