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Virtual Reality and Cryotherapy for Postoperative Pain and Anxiety After Cesarean Section (VRCSTrail)

2026年7月11日 更新者:Zaid Ali Jebur、Shahid Beheshti University of Medical Sciences

Effectiveness of Virtual Reality and Cryotherapy on Postoperative Pain and Anxiety Among Women Undergoing Cesarean Section Under Spinal Anesthesia: A Three-Arm Factorial Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effectiveness of virtual reality and cryotherapy, used separately and in combination, in reducing postoperative pain and anxiety among women undergoing cesarean section under spinal anesthesia. Participants will be randomly assigned to one of three intervention groups or a control group according to the study design. Postoperative pain and anxiety will be assessed using validated measurement tools at predetermined time points after surgery. The findings of this study may provide evidence for safe, non-pharmacological interventions to improve postoperative recovery and patient comfort following cesarean section.

研究概览

详细说明

Cesarean section is one of the most commonly performed surgical procedures worldwide. Despite advances in perioperative care, many women continue to experience moderate to severe postoperative pain and anxiety, which can negatively affect early mobilization, breastfeeding, maternal-infant bonding, and overall recovery. Although pharmacological analgesia remains the standard of care, non-pharmacological interventions may provide additional benefits while minimizing medication-related adverse effects.

Virtual reality is an immersive distraction technique that has shown promise in reducing pain perception and anxiety in various clinical settings. Cryotherapy is another non-pharmacological intervention that may reduce pain through local cooling, decreased nerve conduction velocity, and reduced inflammatory responses. However, evidence regarding their combined effectiveness after cesarean section remains limited.

The purpose of this randomized controlled trial is to evaluate the effectiveness of virtual reality and cryotherapy, individually and in combination, on postoperative pain and anxiety among women undergoing cesarean section under spinal anesthesia. Eligible participants will be randomly allocated to the study groups according to the trial protocol. Pain and anxiety outcomes will be measured using validated assessment instruments at predefined postoperative time points. The primary outcomes are postoperative pain intensity and anxiety. The results are expected to contribute to evidence-based postoperative nursing care by identifying effective, safe, and feasible non-pharmacological interventions for women undergoing cesarean section.

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

Female participants aged 18 to 45 years. Undergoing elective or emergency cesarean section under spinal anesthesia. Hemodynamically stable after surgery. Able to understand Arabic. Conscious, oriented, and able to complete study questionnaires. Willing to participate and provide written informed consent.

Exclusion Criteria:

Undergoing cesarean section under general anesthesia. Severe postoperative complications requiring intensive care. Severe visual or hearing impairment preventing virtual reality use. History of epilepsy or seizure disorder. Severe motion sickness or vestibular disorders. Known psychiatric illness interfering with outcome assessment. Cognitive impairment preventing completion of questionnaires. Skin disease, wound complications, cold hypersensitivity, Raynaud's phenomenon, or allergy/intolerance to cryotherapy.

Severe intraoperative or postoperative bleeding. Refusal to participate or withdrawal of informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Virtual Reality
Participants receive a 30-minute virtual reality intervention using a head-mounted display with calming audiovisual content in addition to routine postoperative care following cesarean section under spinal anesthesia.
Participants receive a 30-minute immersive virtual reality session using a head-mounted display with calming, non-violent audiovisual content during the early postoperative period after cesarean section under spinal anesthesia. The intervention is administered according to a standardized protocol.
其他名称:
  • Head-Mounted Display (HMD)
实验性的:Cryotherapy
Participants receive cryotherapy using cold gel packs (10-15°C) applied over or near the cesarean incision area for 15 minutes with a protective barrier, in addition to routine postoperative care.
Participants receive localized cryotherapy using cold gel packs maintained at approximately 10-15°C and applied over or near the cesarean incision area for 15 minutes with a protective barrier between the cold pack and the skin. Skin integrity is monitored before and after treatment.
其他名称:
  • Cold Gel Pack
无干预:Routine Care Control
Participants receive routine postoperative care according to the hospital protocol without virtual reality or cryotherapy during the study assessment period.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative Pain Intensity
大体时间:Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
Postoperative pain intensity measured using the Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).

次要结果测量

结果测量
措施说明
大体时间
Anxiety Score
大体时间:Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
Anxiety measured using the Arabic version of the State-Trait Anxiety Inventory (STAI-State).
Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
Time to First Rescue Analgesia
大体时间:Up to 6 hours after the intervention.
Time from completion of the intervention to the first administration of rescue analgesic medication.
Up to 6 hours after the intervention.
Total Analgesic Consumption
大体时间:Up to 6 hours after the intervention.
Total postoperative analgesic consumption during the observation period.
Up to 6 hours after the intervention.
Adverse Events
大体时间:Throughout the intervention and postoperative observation period (up to 6 hours after the intervention).
Incidence of adverse events related to virtual reality or cryotherapy, including dizziness, nausea, headache, eye strain, motion sickness, excessive cold sensation, skin redness, numbness, burning sensation, or other treatment-related events.
Throughout the intervention and postoperative observation period (up to 6 hours after the intervention).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月12日

初级完成 (估计的)

2026年9月12日

研究完成 (估计的)

2026年10月12日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月11日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

There is no plan to make individual participant data (IPD) available to other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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