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CompletedNCT06841744Updated Dec 10, 2025

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

An interventional study of Diaphragmatic Breathing Exercise and Information brochure in Pregnancy Related and Low Back Pain, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pregnancy Related
  • Low Back Pain

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03

In context

Low Back Pain

2,817 studies on the registry are indexed under Low Back Pain; 481 are open to participants now.

This study's enrollment of 58 is close to the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 191 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Diaphragmatic Breathing Group

    Other: Diaphragmatic Breathing Exercise · Other: Information brochure

  • Active comparator
    Control Group

    Other: Information brochure

Interventions

  • OtherDiaphragmatic 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.

  • OtherInformation brochure

    An information brochure on ergonomic strategies for managing low back pain during pregnancy will be provided.

06

What researchers measure

Primary outcomes

  1. Numeric Pain Rating Scale

    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."

    Time frame: Baseline, 6 weeks

  2. Oswestry Disability Index

    A questionnaire measuring disability associated with low back pain.

    Time frame: Baseline, 6 weeks

Secondary outcomes

  1. Timed up and go test

    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.

    Time frame: Baseline, 6 weeks

  2. The Single Leg Stance Test

    The Single Leg Stand Test will be performed on the dominant leg, with eyes open and closed.

    Time frame: Baseline, 6 weeks

  3. Quality of Life in Pregnancy Scale

    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.

    Time frame: Baseline, 6 weeks

07

Study locations

1 site
  • İzmir Katip Çelebi University
    Izmir, Çigli 35620, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06841744
Lead sponsor
Izmir Katip Celebi University
Responsible party
Kübra Akkurt (Physiotherapist, Izmir Katip Celebi University) — Principal investigator
First posted
Feb 24, 2025
Start date
Feb 26, 2025
Primary completion
Nov 12, 2025
Completion
Nov 12, 2025
Last update
Dec 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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