Pregnancy RelatedNCT06841744
Effects of Diaphragmatic Breathing on Pain, Function, Balance and Quality of Life in Pregnant Women With Low Back Pain
A study testing Diaphragmatic Breathing Exercise and Information brochure in people with Pregnancy Related and Low Back Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Low Back Pain
- What is being tested?
- Diaphragmatic Breathing Exercise and Information brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2025to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University
Izmir, Çigli, 35620
About this study
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.
- Conditions
- Pregnancy Related, Low Back Pain
- Being tested
- Diaphragmatic Breathing Exercise, Information brochure
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Breathing ExerciseOther
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.
Information brochureOther
An information brochure on ergonomic strategies for managing low back pain during pregnancy will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing Group | Experimental | Not described Receives: Other: Diaphragmatic Breathing Exercise; Other: Information brochure |
| Control Group | Active comparator | Not described Receives: Other: Information brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline, 6 weeks
Oswestry Disability Index
A questionnaire measuring disability associated with low back pain.
Measured: Baseline, 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline, 6 weeks
The Single Leg Stance Test
The Single Leg Stand Test will be performed on the dominant leg, with eyes open and closed.
Measured: Baseline, 6 weeks
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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start26 Feb 2025
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Akkurt, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841744
- Sponsor's protocol ID
- 0196
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic Breathing on Pain, Function, Balance and Quality of Life in Pregnant Women With Low Back Pain
- ClinicalTrials.gov ID
- NCT06841744
- Acronym / sponsor ID
- 0196
- Conditions
- Pregnancy Related, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing Group | Experimental | Other: Diaphragmatic Breathing Exercise, Other: Information brochure |
| Control Group | Active comparator | Other: Information brochure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- History of cardiovascular disease
- Multiple pregnancy
- Medical complications (e.g., bleeding, pre-eclampsia, placenta previa, etc.)
- Diagnosed cognitive disorders
- High-risk pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic Breathing ExerciseDiaphragmatic 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 | Diaphragmatic Breathing Group |
| Information brochureAn information brochure on ergonomic strategies for managing low back pain during pregnancy will be provided. | Other | Control Group, Diaphragmatic Breathing Group |
Primary outcome
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."
Oswestry Disability Index
Time frame: Baseline, 6 weeks
A questionnaire measuring disability associated with low back pain.
3 secondary outcomes
Timed up and go test
Time frame: Baseline, 6 weeks
The Single Leg Stance Test
Time frame: Baseline, 6 weeks
Quality of Life in Pregnancy Scale
Time frame: Baseline, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing Exercise and Information brochure in people with Pregnancy Related and Low Back Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: Baseline, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.