Pain AlleviationSatisfactionNCT07702773
The Effect of Sacral Massage and Sterile Water Injection During Childbirth on Pain Level and Birth Satisfaction
A study testing Sterile Water Injection and sacral press in people with Pain Alleviation and Birth, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Childbirth is a physiological, psychological, and social process. Ineffective management of lower back pain during labor reduces oxygen supply to the fetus, increasing hypoxia, distress, perinatal morbidity, and mortality rates. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Alleviation, Birth
- What is being tested?
- Sterile Water Injection and sacral press
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 19 years and older
- 38-42. being in the gestational week,
- Having a singleton pregnancy,
- Being nulliparous,
- Dilation of 6 cm or more (as it meets the active labor criterion),
- Having regular contractions,
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- Not receiving oxytocin induction (for experimental groups),
- Absence of bleeding diathesis and pathology in coagulation tests,
- Fetus in vertex position,
- No history of EMR (Early Rupture of Membranes),
- Absence of a chronic disease,
- Absence of communication and perception problems,
- Voluntary participation in the study
Who cannot join
- Experiencing any complications during delivery,
- Having a history of using analgesic drugs to accelerate delivery
Trial locations and contacts
1 site in 1 country.
About this study
Childbirth is a physiological, psychological, and social process. Ineffective management of lower back pain during labor reduces oxygen supply to the fetus, increasing hypoxia, distress, perinatal morbidity, and mortality rates. Non-pharmacological approaches such as massage, breathing techniques, sterile water injection, aromatherapy, hydrotherapy, transcutaneous nerve stimulation, and acupressure are used to reduce pain during childbirth. Sterile Water Injection (SSI) is one of the non-pharmacological methods applied to reduce lower back pain during childbirth. Injecting sterile water into the skin acts as a pain stimulant that alters pain perception in women experiencing severe back and lower back pain during labor. SSI is considered an attractive and current method for reducing lower back pain during childbirth due to its lack of side effects and risk to the fetus. Sacral massage, on the other hand, is applied to pregnant women, usually in the form of back or sacral massage, to reduce pain perception and increase comfort during childbirth. The mechanism of action of both Sterile Water Injection and sacral massage applied to the sacral region is the same and bypasses the gate mechanisms expressed by gate control theory. It prevents the pain-causing agent from passing through the "door," thus preventing the pain stimulus from reaching consciousness. Sacral massage and sterile water injection applied during labor stimulate the central nervous system, causing a number of hormonal changes. Furthermore, the central nervous system stimulates oxytocin release, leading to mental detachment from pain and reduced anxiety. Therefore, women giving birth can tolerate pain better. Birth satisfaction is crucial for maintaining maternal and infant health. The provision of quality healthcare services is directly proportional to a positive birth experience and maternal satisfaction. Since sterile water injection and sacral massage are low-cost interventions with no side effects for the mother and fetus, they can be easily applied to alleviate labor pain among women giving birth. The literature shows a limited number of studies comparing sterile water injection and sacral massage in the sacral region during labor. This study will be conducted to determine the effect of sterile water injection and sacral massage applied to the sacral region on labor pain and satisfaction in pregnant women.
- Conditions
- Pain Alleviation, Birth
- Being tested
- Sterile Water Injection, sacral press
- Keywords
- Sterile Water Injection, Sacral massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile Water InjectionProcedure or surgery
Intradermal or subcutaneous sterile water injection administered to the lumbar/sacral region to relieve severe back pain during labor.
sacral pressProcedure or surgery
Continuous manual pressure applied to the sacral area during labor contractions to alleviate back pain.
| Study group | Role | What they receive |
|---|---|---|
| Sterile Water Injection group1 | Experimental | Sterile water is a pain stimulant that alters pain perception in women experiencing severe back and pelvic pain during childbirth, when injected into the skin. Receives: Procedure: Sterile Water Injection |
| Sacral massage group 2 | Experimental | Sacral massage is applied to pregnant women, usually in the form of back or sacral massage, to the sacral region to reduce pain perception and increase comfort during childbirth. Receives: Procedure: sacral press |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) score for labor pain
The VAS is a 10-cm horizontal line leadership tool used to measure pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more severe pain.
Measured: During labor at 6 cm, and 10 cm of cervical dilations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start23 Feb 2026
- Primary completion28 Aug 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain AlleviationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Guveri, Sivas Numune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702773
- Sponsor's protocol ID
- 2025-10/03
- Acronym
- Satisfaction
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sacral Massage and Sterile Water Injection During Childbirth on Pain Level and Birth Satisfaction
- ClinicalTrials.gov ID
- NCT07702773
- Acronym / sponsor ID
- Satisfaction / 2025-10/03
- Conditions
- Pain Alleviation, Birth
- Keywords
- Sterile Water Injection, Sacral massage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 14 Jul 2026 (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.
Childbirth is a physiological, psychological, and social process. Ineffective management of lower back pain during labor reduces oxygen supply to the fetus, increasing hypoxia, distress, perinatal morbidity, and mortality rates. Non-pharmacological approaches such as massage, breathing techniques, sterile water injection, aromatherapy, hydrotherapy, transcutaneous nerve stimulation, and acupressure are used to reduce pain during childbirth. Sterile Water Injection (SSI) is one of the non-pharmacological methods applied to reduce lower back pain during childbirth. Injecting sterile water into the skin acts as a pain stimulant that alters pain perception in women experiencing severe back and lower back pain during labor. SSI is considered an attractive and current method for reducing lower back pain during childbirth due to its lack of side effects and risk to the fetus. Sacral massage, on the other hand, is applied to pregnant women, usually in the form of back or sacral massage, to reduce pain perception and increase comfort during childbirth. The mechanism of action of both Sterile Water Injection and sacral massage applied to the sacral region is the same and bypasses the gate mechanisms expressed by gate control theory. It prevents the pain-causing agent from passing through the "door," thus preventing the pain stimulus from reaching consciousness. Sacral massage and sterile water injection applied during labor stimulate the central nervous system, causing a number of hormonal changes. Furthermore, the central nervous system stimulates oxytocin release, leading to mental detachment from pain and reduced anxiety. Therefore, women giving birth can tolerate pain better. Birth satisfaction is crucial for maintaining maternal and infant health. The provision of quality healthcare services is directly proportional to a positive birth experience and maternal satisfaction. Since sterile water injection and sacral massage are low-cost interventions with no side effects for the mother and fetus, they can be easily applied to alleviate labor pain among women giving birth. The literature shows a limited number of studies comparing sterile water injection and sacral massage in the sacral region during labor. This study will be conducted to determine the effect of sterile water injection and sacral massage applied to the sacral region on labor pain and satisfaction in pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sterile Water Injection group1 | Experimental | Procedure: Sterile Water InjectionSterile water is a pain stimulant that alters pain perception in women experiencing severe back and pelvic pain during childbirth, when injected into the skin. |
| Sacral massage group 2 | Experimental | Procedure: sacral pressSacral massage is applied to pregnant women, usually in the form of back or sacral massage, to the sacral region to reduce pain perception and increase comfort during childbirth. |
| control group | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Being 19 years and older
- 38-42. being in the gestational week,
- Having a singleton pregnancy,
- Being nulliparous,
- Dilation of 6 cm or more (as it meets the active labor criterion),
Key exclusion criteria (2 listed)
- Experiencing any complications during delivery,
- Having a history of using analgesic drugs to accelerate delivery
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 |
|---|---|---|
| Sterile Water InjectionIntradermal or subcutaneous sterile water injection administered to the lumbar/sacral region to relieve severe back pain during labor. | Procedure or surgery | Sterile Water Injection group1 |
| sacral pressContinuous manual pressure applied to the sacral area during labor contractions to alleviate back pain. | Procedure or surgery | Sacral massage group 2 |
Primary outcome
Visual analog scale (VAS) score for labor pain
Time frame: During labor at 6 cm, and 10 cm of cervical dilations.
The VAS is a 10-cm horizontal line leadership tool used to measure pain intensity. Scores range from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more severe pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to protect participant confidentiality.
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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 Sterile Water Injection and sacral press in people with Pain Alleviation and Birth, run by Cumhuriyet 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 13 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual analog scale (VAS) score for labor pain (time frame: During labor at 6 cm, and 10 cm of cervical dilations.). 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 14 Jul 2026.