NCT06841744

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

February 26, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

February 19, 2025

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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."

    Baseline, 6 weeks

  • Oswestry Disability Index

    A questionnaire measuring disability associated with low back pain.

    Baseline, 6 weeks

Secondary Outcomes (3)

  • Timed up and go test

    Baseline, 6 weeks

  • The Single Leg Stance Test

    Baseline, 6 weeks

  • Quality of Life in Pregnancy Scale

    Baseline, 6 weeks

Study Arms (2)

Diaphragmatic Breathing Group

EXPERIMENTAL
Other: Diaphragmatic Breathing ExerciseOther: Information brochure

Control Group

ACTIVE COMPARATOR
Other: Information brochure

Interventions

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.

Diaphragmatic Breathing Group

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

Control GroupDiaphragmatic Breathing Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Katip Çelebi University

Izmir, Çigli, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 24, 2025

Study Start

February 26, 2025

Primary Completion

November 12, 2025

Study Completion

November 12, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations