Effects of Diaphragmatic Breathing on Pain, Function, Balance and Quality of Life in Pregnant Women With Low Back Pain

December 9, 2025 updated by: Kübra Akkurt, Izmir Katip Celebi University
The aim of the study was to investigate the effects of diaphragmatic breathing on pain, function, balance and quality of life in pregnant women with low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Individuals with pregnancy-related low back pain who present to the Obstetrics and Gynecology Clinic of İzmir Menemen State Hospital are identified as the study population. Patients meeting the eligibility criteria will be included in the study.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Çigli
      • Izmir, Çigli, Turkey (Türkiye), 35620
        • Izmir Katip Celebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 18 years of age
  • Pregnancy between 19-29 weeks
  • Low back pain that started with pregnancy (at least 1 week; no previous history of low back pain)
  • No treatment for the lumbar region or spine in the last 3 months

Exclusion Criteria:

  • History of cardiovascular disease
  • Multiple pregnancy
  • Medical complications (e.g., bleeding, pre-eclampsia, placenta previa, etc.)
  • Diagnosed cognitive disorders
  • High-risk pregnancy
  • History of abdominal and/or thoracic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Other: Information brochure
An information brochure on ergonomic strategies for managing low back pain during pregnancy will be provided.
Experimental: Diaphragmatic Breathing Group
Other: Diaphragmatic Breathing Exercise
Diaphragmatic breathing exercises will be performed twice a day, completing 3 sets of 10 repetitions, 5 days a week for 6 weeks, as instructed by the researcher physiotherapist.
Other: Information brochure
An information brochure on ergonomic strategies for managing low back pain during pregnancy will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: Baseline, 6 weeks
A questionnaire measuring disability associated with low back pain.
Baseline, 6 weeks
Numeric Pain Rating Scale
Time Frame: Baseline, 6 weeks
The Numeric Pain Rating Scale (NPRS) assesses pain severity using a 0-10 scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go test
Time Frame: Baseline, 6 weeks
It measures the time required for a person to rise from a chair, walk three meters, turn, walk back to the chair, and sit down.
Baseline, 6 weeks
The Single Leg Stance Test
Time Frame: Baseline, 6 weeks
The Single Leg Stand Test will be performed on the dominant leg, with eyes open and closed.
Baseline, 6 weeks
Quality of Life in Pregnancy Scale
Time Frame: Baseline, 6 weeks
The Quality of Life in Pregnancy Scale aims to assess the quality of life of women with a normal pregnancy and consists of 9 items.The total score of the scale ranges from 9 to 45, with lower scores indicating better quality of life.
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Actual)

November 12, 2025

Study Completion (Actual)

November 12, 2025

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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