- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04862039
Use of Virtual Reality in Active Labor
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. These limits concurred to the application of these techniques mainly on demand and not routinely.
For all these reasons, it is not surprising the interest in offering women valid non-invasive and cheaper options to relieve them from pain. As of today many alternative techniques have been proposed, many of which have not, as of today, met a large scientific consensus, as shown by many recent Cochrane reviews. A promising perspective for non-pharmacological analgesia seems to be offered by Virtual Reality (VR) devices, which have been applied to many different medical areas. Recently Frey et al. have experimented in a pilot study the application of this technique to women during labor, obtaining interesting results. The authors of this study point, in the discussion of the scientific paper, to the necessity of developing virtual reality experiences more specific to labor and suggest different implementations, such as specific instructions for women (changes of position, breathing techniques) greater comfort (it is worth noticing the use on our side of exclusively wireless devices) and the implementation of the device with biofeedback.
In addition to learning from these suggestions, we tried to imagine VR in a different way: firstly as complementary, not alternative to the role of the midwife personnel, who will play a central role in our experimental treatment enriching the virtual reality scenario with their instructions, presence and motivational feedback; secondly we tried to imagine VR as a guide through labor, more than a alienation and distraction tool.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Naples, Italien, 80100
- Gabriele Saccone
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- singleton gestations;
- term pregnancy
- spontaneous labor
- diagnosis of active phase of labor;
- nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
Exclusion Criteria:
- multiple gestations;
- preterm labor;
- preterm premature rupture of membranes
- induction to delivery labor;
- hipertensive disorders;
- fetal abnormalities;
- diabetes mellitus;
- intrauterine growth retardation;
- post-term pregnancy;
- multiple vaginal delivery;
- women with an altered state of consciousness, severely ill, mentally disabled;
- women with sight and/or hearing impairment;
- women at risk of epileptic seizures;
- women with predisposition to motion sickness;
- women under the age of 18 years or over the age of 45 years;
- Women who refuse to sign informed informed consent form.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Virtual Reality (VR) devices
intervention group (VR).
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Virtual Reality (VR) devices.
Subjects receiving the experimental treatment will be given a VR headset, headphones and wristband and the Philips wireless fetal-maternal monitoring system, after the necessary preparation of the abdominal skin.
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Ingen indgriben: control group
the standard of care (control group, no VR)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Subjective pain during the active phase
Tidsramme: "during the active phase of labor up to 10 cm"
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women pain using visual analogue scale (VAS)
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"during the active phase of labor up to 10 cm"
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
nausea
Tidsramme: during the active phase of labor (i.e. after 4-6 cm of dilatation)
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nausea referred by the patient and episodes of vomiting
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during the active phase of labor (i.e. after 4-6 cm of dilatation)
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anxiety
Tidsramme: during the active phase of labor (i.e. after 4-6 cm of dilatation)
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women axneity using visual analogue scale (VAS)
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during the active phase of labor (i.e. after 4-6 cm of dilatation)
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Incidence of episiotomy
Tidsramme: at the time of delivery
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Incidence of episiotomy
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at the time of delivery
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 485/20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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