CompletedNot Applicable

Low Back Pain Support Program During Pregnancy: A Randomized Controlled Trial

Turkey (Türkiye)80 participantsStarted 2021-07-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * Read and write in Turkish, * 18 years and over aged, * Three or more score low back pain according to VAS * Singleton pregnancy Exclusion Criteria: 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

pregnancy related low back pain

Timeframe: each participant will be re-evaluated at the end of 4 weeks

quality of life in pregnancy

Timeframe: each participant will be re-evaluated at the end of 4 weeks

Trial details

NCT IDNCT05684497

SponsorKastamonu University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-30

View on ClinicalTrials.gov More Low Back Pain trials