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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).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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,
Show all 13Show fewer
  • 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.

Turkey (Türkiye)1 site
  • Sivas Numune Hospital

    Sivas, Sivas

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07702773
Study groupRoleWhat they receive
Sterile Water Injection group1ExperimentalSterile 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 2ExperimentalSacral 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 groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted14 Jul 2026
  2. Study start23 Feb 2026
  3. Primary completion28 Aug 2026 (estimated)
  4. Study completion25 Sep 2026 (estimated)

Resources

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)
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.

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.

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