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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05684497
Other study ID # Kastamonu University
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 9, 2021
Est. completion date December 30, 2022

Study information

Verified date January 2023
Source Kastamonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although pregnancy is a natural process, it is a period in which some bio-physiological changes are experienced. These changes cause low back pain by affecting the musculoskeletal system as well as the endocrine, cardiovascular and renal systems. Pregnancy-related low back pain is defined as recurrent pain in the lumbopelvic region lasting more than one week. It can manifest itself in pregnancy as low back pain, lumbar pain, pelvic pain and lumbopelvic pain where both are present. In order to cope with low back pain in pregnancy and to increase the quality of life, low back pain should be evaluated in antenatal and postnatal follow-ups. Risk factors should be examined, women in the risk group should be identified, their low back pain experience should be questioned, prevention and coping strategies and the effect of low back pain on their quality of life should be evaluated. Healthy lifestyle programs should be developed to help prevent low back pain and develop coping strategies for pregnant women with low back pain.


Description:

Although pregnancy is a natural process, it is a period in which some bio-physiological changes are experienced. These changes cause low back pain by affecting the musculoskeletal system as well as the endocrine, cardiovascular and renal systems. Pregnancy-related low back pain is defined as recurrent pain in the lumbopelvic region lasting more than one week. Low back pain in pregnancy has been known for centuries and was described in ancient times by physicians such as Hippocrates, Vesalius, Pinean, Hunter, and Velpeau. Walde distinguished between pelvic pain and lumbar pain for the first time in 1962. It can manifest itself in pregnancy as low back pain, lumbar pain, pelvic pain and lumbopelvic pain where both are present. Low back pain in pregnancy is usually 20-28. Although it can be seen in the first trimester of pregnancy, it can also be seen in the first trimester. 40% of women who experience low back pain during pregnancy continue to experience pain for 6 months postpartum, 30% for 12 months postpartum, and 10% for 24 months postpartum. In the literature, the prevalence of low back pain, which is very common during pregnancy, is reported to be 25-90%. In the literature, reported low back pain in pregnancy as 76.6% in a study conducted in Ontario. In the literature, reported the prevalence of low back pain in pregnancy as 83.5% in another study conducted in Pakistan. Although studies on the prevalence of low back pain in pregnancy are limited in our country, prevalance reported of low back pain during pregnancy was 53.93% in a study conducted in the province of Ağrı. In another study conducted in Kayseri this rate was reported as 54.1%. In another study reported the prevalence of low back pain as 75.3% in the study conducted in Kastamonu. The etiology of low back pain in pregnancy is multifactorial and generally depends on hormonal, metabolic and vascular changes. In addition, many factors such as genetic factors, increased parity, postural changes, body mass index, smoking, sedentary lifestyle, stressful life, infection, history of low back pain in previous pregnancy, history of low back pain before pregnancy, working in a strenuous job create risk. It is stated in the literature that low back pain during pregnancy affects women's quality of life negatively. Decreased physical activity with low back pain causes social and economic problems by bringing anxiety and depression. It is reported in the literature that low back pain experienced during pregnancy reduces the quality of life by having a negative effect on physical activity, personal care, sleep quality, social life, work life, sexual life, energy and mood. In a study to examine the quality of life of women with low back pain during pregnancy, it was reported that women with low back pain during pregnancy had lower physical, mental and social scores, and their quality of life decreased as the severity of pain increased. Low back pain experienced during pregnancy is seen as a part of pregnancy by both women and health professionals, and is neglected on the grounds that it does not pose a serious risk for the mother and baby. However, low back pain experienced during pregnancy negatively affects the quality of life, can be permanent in the postpartum period and cause postpartum depression. In order to cope with low back pain in pregnancy and to increase the quality of life, low back pain should be evaluated in antenatal and postnatal follow-ups.Risk factors should be examined, women in the risk group should be identified, their low back pain experience should be questioned, prevention and coping strategies and the effects of low back pain on their quality of life should be evaluated. Healthy lifestyle programs should be developed to help prevent low back pain and develop coping strategies for pregnant women with low back pain. Within the healthy lifestyle program; Providing the right posture, providing ideal weight gain during pregnancy and preventing constipation, individual nutrition education, prevention of urinary tract infections, healthy sexual life, regulation of activity, position change, ergonomics training, adequate rest, appropriate shoe selection, smoking cessation, stress management, non It should contribute to reducing low back pain and increasing the quality of life by including pharmacological methods of coping with pain. Pender's Health Promotion Model guides the planning, implementation and evaluation of health protection and promotion behaviors. Pender's Health Promotion Model will be a guide in the counseling that nurses will give on the prevention of low back pain in pregnancy and the development of strategies to cope with low back pain.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Can read and write Turkish, - 18 years and over, - Applying to the family health center between the research dates, - Having persistent or intermittent low back pain in the last week (3 or more according to VAS), - Singular current pregnancy, - Women who participated in the study voluntarily were included. Exclusion Criteria: - Over the 32nd week of pregnancy, - A history of acute or chronic disease, trauma, surgery related to the musculoskeletal or nervous system, - Gynecological or urological problems that cause pain during pregnancy (premature birth, pyelonephritis, etc.) - Using analgesics during pregnancy, - Risky pregnancies where bed rest is recommended during pregnancy, - Pregnant women with communication difficulties and mental disabilities

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Low Back Pain Prevention and Coping Support Program Training in Pregnancy
Preventing low back pain and developing coping strategies with the Pregnancy Low Back Pain Prevention and Coping Support Program based on Pender's Health Promotion Model

Locations

Country Name City State
Turkey Münevver Aybüke Berber Çikrik Kastamonu Kastamonu/Center

Sponsors (1)

Lead Sponsor Collaborator
Kastamonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary pregnancy related low back pain measurement of low back pain life status of pregnant women with VAS each participant will be re-evaluated at the end of 4 weeks
Primary quality of life in pregnancy measurement of pregnant women's quality of life with Oswestry disability index each participant will be re-evaluated at the end of 4 weeks
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