Low Back Pain Support Program During Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- pregnancy related low back pain
研究概览
简要总结
Purpose of Research: The study was conducted as a randomized controlled experimental study to evaluate the effect of the Low Back Pain During Pregnancy Support Program (LBPSP).
Research Hypotheses H1: The perception of back pain during pregnancy in the intervention group receiving the "Low Back Pain During Pregnancy Support Program (LBPSP) will decrease compared to the control group.
H2: The Oswestry Disability Index scores of the intervention group receiving the Low Back Pain During Pregnancy Support Program (LBPSP) will decrease compared to the control group.
First interview Introductory Information Form, Low Back Pain Evaluation Form, Visual Analog Scale (VAS), and Oswestry Disability Index were applied to all pregnant women in the intervention and control groups participating in the study as pre-test at the first interview. The intervention group was conducted a LBPSP, the control group were not and were left to routine antenatal care.Four weeks after the first interview, Intervention and control groups were interviewed again, and the Low Back Pain Evaluation Form and Oswestry Disability Index scales were applied. In addition, the LBPSP Evaluation Form prepared by the researcher was applied to the pregnant women in the intervention group to evaluate the LBPSP.
详细描述
The research population consisted of all pregnant women registered at a Family Health Center between July 2021 and July 2022.The power of the study was calculated in the G*Power (v3.1.9.4) program to determine the number of samples. Oswestry Disability Index was taken as the main parameter in the study. In the survey conducted by Pekcetin et al., the Oswestry Disability Index scale score average of the group to be trained was found to be 39.53 ±14.04 before the training and 26.96 ±13.69 after the training (Pekcetin et al., 2019). In the statistical analysis performed by taking the results of this study as a criterion, the alpha reliability level of the survey was taken as 0.01. The power was 80%, and according to the Oswestry Disability Index scale, the score was average. It was determined that 36 pregnant women should be included in the group. However, considering the possibility of data loss, a total of 80 pregnant women, 40 were included in the group that would be included in the low back pain prevention and coping support program in addition to routine pregnant care, and 40 were included in the group that would receive only routine antenatal care.
The allocation of intervention and control groups was determined using the simple random sampling method (random.org). The numbers determined by the simple random sampling method became the appointment order.
Criteria for inclusion in the study;
- Read and write in Turkish,
- 18 years and over aged,
- Three or more score low back pain according to VAS
- Singleton pregnancy
Exclusion criteria from the study:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Gynecological or urological problems that cause pain during pregnancy (premature birth, pyelonephritis, etc.)
- •Using analgesics during pregnancy,
- •Risky pregnancies for which bed rest is recommended during pregnancy,
- •Were not included in the study.
结局指标
主要结局
pregnancy related low back pain
时间窗: each participant will be re-evaluated at the end of 4 weeks
measurement of low back pain life status of pregnant women with VAS
quality of life in pregnancy
时间窗: each participant will be re-evaluated at the end of 4 weeks
measurement of pregnant women's quality of life with Oswestry disability index
次要结局
未报告次要终点
研究者
Munevver Aybuke Berber Cikrik
Assistant professor
Kastamonu University