Use of Virtual Reality in Active Labor
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Naples、イタリア、80100
- Gabriele Saccone
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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介入なし:control group
the standard of care (control group, no VR)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Subjective pain during the active phase
時間枠:"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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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nausea
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。