- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07702773
The Effect of Sacral Massage and Sterile Water Injection During Childbirth on Pain Level and Birth Satisfaction (Satisfaction)
13. juli 2026 oppdatert av: Hilal Guveri, Cumhuriyet University
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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Sivas
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Sivas, Sivas, Tyrkia (Türkiye)
- Sivas Numune Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- 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,
- 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
Exclusion Criteria:
- Experiencing any complications during delivery,
- Having a history of using analgesic drugs to accelerate delivery
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: kontrollgruppe
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Eksperimentell: Sterile Water Injection group1
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.
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Intradermal or subcutaneous sterile water injection administered to the lumbar/sacral region to relieve severe back pain during labor.
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Eksperimentell: Sacral massage group 2
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.
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Continuous manual pressure applied to the sacral area during labor contractions to alleviate back pain.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Visual analog scale (VAS) score for labor pain
Tidsramme: During labor at 6 cm, and 10 cm of cervical dilations.
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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.
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During labor at 6 cm, and 10 cm of cervical dilations.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. februar 2026
Primær fullføring (Antatt)
28. august 2026
Studiet fullført (Antatt)
25. september 2026
Datoer for studieregistrering
Først innsendt
30. juni 2026
Først innsendt som oppfylte QC-kriteriene
13. juli 2026
Først lagt ut (Faktiske)
14. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. juli 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2025-10/03
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be available to protect participant confidentiality.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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