Low Back PainNCT05684497
Low Back Pain Support Program During Pregnancy: A Randomized Controlled Trial
A study testing LBPSP in Pregnancy in people with Low Back Pain and Pregnancy Related, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Pregnancy Related, Nurse's Role
- What is being tested?
- LBPSP in Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jul 2021to 30 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Read and write in Turkish,
- 18 years and over aged,
- Three or more score low back pain according to VAS
- Singleton pregnancy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Münevver Aybüke Berber Çıkrık
Kastamonu, Kastamonu/Center, 37000
About this study
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.
Read more
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.
Read the detailed description
The research population consisted of all pregnant women registered at a Family Health Center between July 2021 and July 2022.The power of the study was calculated in the G*Power (v3.1.9.4) program to determine the number of samples. Oswestry Disability Index was taken as the main parameter in the study. In the survey conducted by Pekcetin et al., the Oswestry Disability Index scale score average of the group to be trained was found to be 39.53 ±14.04 before the training and 26.96 ±13.69 after the training (Pekcetin et al., 2019). In the statistical analysis performed by taking the results of this study as a criterion, the alpha reliability level of the survey was taken as 0.01. The power was 80%, and according to the Oswestry Disability Index scale, the score was average. It was determined that 36 pregnant women should be included in the group. However, considering the possibility of data loss, a total of 80 pregnant women, 40 were included in the group that would be included in the low back pain prevention and coping support program in addition to routine pregnant care, and 40 were included in the group that would receive only routine antenatal care.
The allocation of intervention and control groups was determined using the simple random sampling method (random.org). The numbers determined by the simple random sampling method became the appointment order.
Criteria for inclusion in the study;
- Read and write in Turkish,
- 18 years and over aged,
- Three or more score low back pain according to VAS
- Singleton pregnancy
Exclusion criteria from the study:
- 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. After the researcher called the pregnant women via phone and evaluated their compliance with the research criteria, the pregnant women who met the inclusion criteria were informed about the research and invited to the study. Data were collected by face-to-face interviews with all pregnant women in the study in an isolated room.
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.
The purpose and content of LBPSP was explained and contucted to the intervention group. LBPSP is a 50-minute interactive presentation as face to face program according to Pender's Health Promotion Model Parameters. LBPSP content is given in Figure 3. And also, a special LBPSP handbook has been prepared for this program, enriched with visuals for pregnant women and printed. This handbook was given to the intervention group after LBPSP.
- Conditions
- Low Back Pain, Pregnancy Related, Nurse's Role
- Being tested
- LBPSP in Pregnancy
- Keywords
- Back Pain; Life Quality; Nursing; Pregnancy, Pender's Health Promotion Model
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBPSP in PregnancyBehavioural
LBPSP is a 50-minute interactive presentation as face to face program according to Pender's Health Promotion Model Parameters.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The intervention group was conducted a LBPSP Receives: Behavioral: LBPSP in Pregnancy |
| control group | No intervention | the control group were not and were left to routine antenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy related low back pain
measurement of low back pain life status of pregnant women with VAS
Measured: each participant will be re-evaluated at the end of 4 weeks
quality of life in pregnancy
measurement of pregnant women's quality of life with Oswestry disability index
Measured: each participant will be re-evaluated at the end of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start9 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munevver Aybuke Berber Cikrik, Kastamonu University
- Investigators
- Münevver Aybüke Berber Çıkrık, Study director, Istanbul University Cerrahpasa Institute of Graduate Education StudiesMünevver Aybüke Berber Çıkrık, Study director, stanbul University Cerrahpasa Institute of Graduate Education Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684497
- Sponsor's protocol ID
- Kastamonu University
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2022
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Back Pain Support Program During Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05684497
- Acronym / sponsor ID
- Kastamonu University
- Conditions
- Low Back Pain, Pregnancy Related, Nurse's Role
- Keywords
- Back Pain; Life Quality; Nursing; Pregnancy, Pender's Health Promotion Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 13 Jan 2023 (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.
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.
Detailed description
The research population consisted of all pregnant women registered at a Family Health Center between July 2021 and July 2022.The power of the study was calculated in the G*Power (v3.1.9.4) program to determine the number of samples. Oswestry Disability Index was taken as the main parameter in the study. In the survey conducted by Pekcetin et al., the Oswestry Disability Index scale score average of the group to be trained was found to be 39.53 ±14.04 before the training and 26.96 ±13.69 after the training (Pekcetin et al., 2019). In the statistical analysis performed by taking the results of this study as a criterion, the alpha reliability level of the survey was taken as 0.01. The power was 80%, and according to the Oswestry Disability Index scale, the score was average. It was determined that 36 pregnant women should be included in the group. However, considering the possibility of data loss, a total of 80 pregnant women, 40 were included in the group that would be included in the low back pain prevention and coping support program in addition to routine pregnant care, and 40 were included in the group that would receive only routine antenatal care.
The allocation of intervention and control groups was determined using the simple random sampling method (random.org). The numbers determined by the simple random sampling method became the appointment order.
Criteria for inclusion in the study;
- Read and write in Turkish,
- 18 years and over aged,
- Three or more score low back pain according to VAS
- Singleton pregnancy
Exclusion criteria from the study:
- 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. After the researcher called the pregnant women via phone and evaluated their compliance with the research criteria, the pregnant women who met the inclusion criteria were informed about the research and invited to the study. Data were collected by face-to-face interviews with all pregnant women in the study in an isolated room.
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.
The purpose and content of LBPSP was explained and contucted to the intervention group. LBPSP is a 50-minute interactive presentation as face to face program according to Pender's Health Promotion Model Parameters. LBPSP content is given in Figure 3. And also, a special LBPSP handbook has been prepared for this program, enriched with visuals for pregnant women and printed. This handbook was given to the intervention group after LBPSP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: LBPSP in PregnancyThe intervention group was conducted a LBPSP |
| control group | No intervention | –the control group were not and were left to routine antenatal care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Read and write in Turkish,
- 18 years and over aged,
- Three or more score low back pain according to VAS
- Singleton pregnancy
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| LBPSP in PregnancyLBPSP is a 50-minute interactive presentation as face to face program according to Pender's Health Promotion Model Parameters. | Behavioural | experimental group |
Primary outcome
pregnancy related low back pain
Time frame: each participant will be re-evaluated at the end of 4 weeks
measurement of low back pain life status of pregnant women with VAS
quality of life in pregnancy
Time frame: each participant will be re-evaluated at the end of 4 weeks
measurement of pregnant women's quality of life with Oswestry disability index
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 22 Nov 2024.
- 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.
Münevver Aybüke Berber Çıkrık study director
Istanbul University Cerrahpasa Institute of Graduate Education Studies
Münevver Aybüke Berber Çıkrık study director
stanbul University Cerrahpasa Institute of Graduate Education Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LBPSP in Pregnancy in people with Low Back Pain and Pregnancy Related, run by Kastamonu 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 4 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 22 Nov 2024. 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?
pregnancy related low back pain (time frame: each participant will be re-evaluated at the end of 4 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 22 Nov 2024.