Labor PainNCT05222867
The Effect of Lower Back Massage on Perceived Labor Pain
A study testing lower back massage in people with Labor Pain, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to assesment the change in pain scores with lower back massage, a non-pharmacological method, on perceived labor pain in the early active phase of the first stage of labor. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- lower back massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 30 Jul 2020
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study group consisted of pregnant women who were at 37-40 weeks of pregnancy,
- had cervical dilatation of 4-6 cm,
- had a single, live, and vertex fetus,
- had an uncomplicated pregnancy,
- had no contraction anomalies,
- could communicate in Turkish
- planned for a vaginal delivery.
Who cannot join
- with cognitive dysfunction
- using narcotic analgesics or sedative drugs
- had any contraindications for applying a back massage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Angle Labor Pain Questionnaire Turkish Version: Validity and Reliability Study and Evaluation of Efficacy With a Non-pharmacological Method
The aim of the study was to assesment the change in pain scores with lower back massage, a non-pharmacological method, on perceived labor pain in the early active phase of the first stage of labor.
- Conditions
- Labor Pain
- Being tested
- lower back massage
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower back massageProcedure or surgery
Lower back massage performance: In the study, Linda Kimber's massage protocol was used. First, the researcher ensured that the patient was holding the bed, squatting, or bent over on the bed, which is suitable for the massage, between two contractions. The pregnant woman was instructed to breathe deeply and exhale audibly when her contractions began. Gloves were worn during the massage and liquid Vaseline, which does not contain any active substance, was used to provide lubricity. The circular hip massage was applied at the beginning of the contraction, and lower lateral area and sacral pressure massage was applied towards the end of the contraction as per the massage protocol, and simultaneously with the inhaling sound of the pregnant woman
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | pregnant women undergoing lower back massage Receives: Procedure: lower back massage |
| control group | No intervention | pregnant women given routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change in pain scores with lower back massage
Lower back massage is a non-pharmacological method to reduce perceived labor pain.
Measured: Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Dec 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Tuncer Yilmaz, Eskisehir Osmangazi University
- Investigators
- NEBAHAT OZERDOGAN, PROF.DR., Study director, ESKISEHIR OSMANGAZI UNIVERSITY FACULTY OF HEALTH SCIENCES DEPARTMENT OF MIDWIFERY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222867
- Sponsor's protocol ID
- ALPQT_NONFARMA
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angle PJ, Kurtz Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Zaki P, Kiss A. Performance of the Angle Labor Pain Questionnaire During Initiation of Epidural Analgesia in Early Active Labor. Anesth Analg. 2016 Dec;123(6):1546-1553. doi: 10.1213/ANE.0000000000001679.
PubMed 27870739Angle P, Landy CK, Charles C, Yee J, Watson J, Kung R, Kronberg J, Halpern S, Lam D, Lie LM, Streiner D. Phase 1 development of an index to measure the quality of neuraxial labour analgesia: exploring the perspectives of childbearing women. Can J Anaesth. 2010 May;57(5):468-78. doi: 10.1007/s12630-010-9289-1. Epub 2010 Mar 13.
PubMed 20229219Capogna G, Camorcia M, Stirparo S, Valentini G, Garassino A, Farcomeni A. Multidimensional evaluation of pain during early and late labor: a comparison of nulliparous and multiparous women. Int J Obstet Anesth. 2010 Apr;19(2):167-70. doi: 10.1016/j.ijoa.2009.05.013. Epub 2010 Mar 9.
PubMed 20219349Angle P, Kurtz-Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Kiss A. The Angle Labor Pain Questionnaire: Reliability, Validity, Sensitivity to Change, and Responsiveness During Early Active Labor Without Pain Relief. Clin J Pain. 2017 Feb;33(2):132-141. doi: 10.1097/AJP.0000000000000386.
PubMed 27685468
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angle Labor Pain Questionnaire Turkish Version: Validity and Reliability Study and Evaluation of Efficacy With a Non-pharmacological Method
- ClinicalTrials.gov ID
- NCT05222867
- Acronym / sponsor ID
- ALPQT_NONFARMA
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 3 Feb 2022 (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 assesment the change in pain scores with lower back massage, a non-pharmacological method, on perceived labor pain in the early active phase of the first stage of labor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: lower back massagepregnant women undergoing lower back massage |
| control group | No intervention | –pregnant women given routine care |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The study group consisted of pregnant women who were at 37-40 weeks of pregnancy,
- had cervical dilatation of 4-6 cm,
- had a single, live, and vertex fetus,
- had an uncomplicated pregnancy,
- had no contraction anomalies,
Key exclusion criteria (3 listed)
- with cognitive dysfunction
- using narcotic analgesics or sedative drugs
- had any contraindications for applying a back massage
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 |
|---|---|---|
| lower back massageLower back massage performance: In the study, Linda Kimber's massage protocol was used. First, the researcher ensured that the patient was holding the bed, squatting, or bent over on the bed, which is suitable for the massage, between two contractions. The pregnant woman was instructed to breathe deeply and exhale audibly when her contractions began. Gloves were worn during the massage and liquid Vaseline, which does not contain any active substance, was used to provide lubricity. The circular hip massage was applied at the beginning of the contraction, and lower lateral area and sacral pressure massage was applied towards the end of the contraction as per the massage protocol, and simultaneously with the inhaling sound of the pregnant woman | Procedure or surgery | Intervention |
Primary outcome
assessment of change in pain scores with lower back massage
Time frame: Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application)
Lower back massage is a non-pharmacological method to reduce perceived labor pain.
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 3 Feb 2022.
- Background: PubMed 27870739Angle PJ, Kurtz Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Zaki P, Kiss A. Performance of the Angle Labor Pain Questionnaire During Initiation of Epidural Analgesia in Early Active Labor. Anesth Analg. 2016 Dec;123(6):1546-1553. doi: 10.1213/ANE.0000000000001679.
- Background: PubMed 20229219Angle P, Landy CK, Charles C, Yee J, Watson J, Kung R, Kronberg J, Halpern S, Lam D, Lie LM, Streiner D. Phase 1 development of an index to measure the quality of neuraxial labour analgesia: exploring the perspectives of childbearing women. Can J Anaesth. 2010 May;57(5):468-78. doi: 10.1007/s12630-010-9289-1. Epub 2010 Mar 13.
- Background: PubMed 20219349Capogna G, Camorcia M, Stirparo S, Valentini G, Garassino A, Farcomeni A. Multidimensional evaluation of pain during early and late labor: a comparison of nulliparous and multiparous women. Int J Obstet Anesth. 2010 Apr;19(2):167-70. doi: 10.1016/j.ijoa.2009.05.013. Epub 2010 Mar 9.
- Results publication: PubMed 27685468Angle P, Kurtz-Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Kiss A. The Angle Labor Pain Questionnaire: Reliability, Validity, Sensitivity to Change, and Responsiveness During Early Active Labor Without Pain Relief. Clin J Pain. 2017 Feb;33(2):132-141. doi: 10.1097/AJP.0000000000000386.
- 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.
NEBAHAT OZERDOGAN, PROF.DR. study director
ESKISEHIR OSMANGAZI UNIVERSITY FACULTY OF HEALTH SCIENCES DEPARTMENT OF MIDWIFERY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lower back massage in people with Labor Pain, run by Eskisehir Osmangazi 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 7 inclusion and 3 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 3 Feb 2022. 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?
assessment of change in pain scores with lower back massage (time frame: Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05222867, which also lists 4 linked publications.
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 3 Feb 2022.