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THE EFFECTS OF PREVENTION PROGRAM ON LOW BACK PAIN AND QUALITY OF LIFE DURING PREGNANCY

Primary Purpose

Low Back Pain, Pregnancy Related, Nurse's Role

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low Back Pain Prevention and Coping Support Program Training in Pregnancy
Sponsored by
Kastamonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Münevver Aybüke Berber Çıkrık

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

The Training on Prevention and Coping Support Program in Pregnancy Based on Pender's Health Promotion Model, which was created by the researcher in line with the current literature, and the training booklet (Appendix-3) containing this training will be provided. Two weeks after the first interview, women will be called and reminded to follow the training booklet, and at the end of four weeks, the Low Back Pain Evaluation Form, Visual Analog Scale (VAS), Oswestry Disability Index and Checklist will be applied.

For women who only receive routine pregnant care, no attempt will be made for low back pain, and the Low Back Pain Evaluation Form, Visual Analog Scale (VAS) and Oswestry Disability Index will be re-applied four weeks after the first interview, according to routine pregnant follow-ups.

Outcomes

Primary Outcome Measures

pregnancy related low back pain
measurement of low back pain life status of pregnant women with VAS
quality of life in pregnancy
measurement of pregnant women's quality of life with Oswestry disability index

Secondary Outcome Measures

Full Information

First Posted
January 16, 2022
Last Updated
January 12, 2023
Sponsor
Kastamonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05684497
Brief Title
THE EFFECTS OF PREVENTION PROGRAM ON LOW BACK PAIN AND QUALITY OF LIFE DURING PREGNANCY
Official Title
THE EFFECT OF PREVENTION AND COPING SUPPORT PROGRAM ON LOW BACK PAIN AND QUALITY OF LIFE DURING PREGNANCY
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kastamonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Pregnancy Related, Nurse's Role

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The Training on Prevention and Coping Support Program in Pregnancy Based on Pender's Health Promotion Model, which was created by the researcher in line with the current literature, and the training booklet (Appendix-3) containing this training will be provided. Two weeks after the first interview, women will be called and reminded to follow the training booklet, and at the end of four weeks, the Low Back Pain Evaluation Form, Visual Analog Scale (VAS), Oswestry Disability Index and Checklist will be applied.
Arm Title
control group
Arm Type
No Intervention
Arm Description
For women who only receive routine pregnant care, no attempt will be made for low back pain, and the Low Back Pain Evaluation Form, Visual Analog Scale (VAS) and Oswestry Disability Index will be re-applied four weeks after the first interview, according to routine pregnant follow-ups.
Intervention Type
Behavioral
Intervention Name(s)
Low Back Pain Prevention and Coping Support Program Training in Pregnancy
Intervention Description
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
Primary Outcome Measure Information:
Title
pregnancy related low back pain
Description
measurement of low back pain life status of pregnant women with VAS
Time Frame
each participant will be re-evaluated at the end of 4 weeks
Title
quality of life in pregnancy
Description
measurement of pregnant women's quality of life with Oswestry disability index
Time Frame
each participant will be re-evaluated at the end of 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Münevver Aybüke Berber Çıkrık
Organizational Affiliation
Istanbul University Cerrahpasa Institute of Graduate Education Studies
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Münevver Aybüke Berber Çıkrık
Organizational Affiliation
stanbul University Cerrahpasa Institute of Graduate Education Studies
Official's Role
Study Director
Facility Information:
Facility Name
Münevver Aybüke Berber Çıkrık
City
Kastamonu
State/Province
Kastamonu/Center
ZIP/Postal Code
37000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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THE EFFECTS OF PREVENTION PROGRAM ON LOW BACK PAIN AND QUALITY OF LIFE DURING PREGNANCY

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