Virtual Reality as a Distraction Technique for Management of Acute Pain at Outpatient Hysteroscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Worst Pain Scores
研究概览
简要总结
TITLE Virtual Reality (VR) as a Distraction technique for management of acute pain at Outpatient Hysteroscopy DESIGN Randomised Control Trial (RCT) with Mixed methods - Qualitative and quantitative AIMS To study the role of distraction techniques for management of acute pain in Outpatient Hysteroscopy and to assess feasibility of using Virtual Reality for managing pain.
Primary objective:
• Feasibility of using virtual reality as a distraction technique in management of acute pain in patients undergoing Outpatient Hysteroscopy.
Secondary objectives:
- Understanding the acceptability and effectiveness of VR interventions within the procedural groups and how these might vary as a function of different patient demographics.
- Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology.
- Understanding how best to implement the technology and designing of the contents of the VR intervention.
- Understanding the effective mechanisms for the analgesic effect of VR and explore how this could be tailored to individual patients.
POPULATION Patients attending the Outpatient Hysteroscopy clinics ELIGIBILITY Patients undergoing Outpatient Hysteroscopy DURATION 6 months
详细描述
INTRODUCTION
BACKGROUND Performing procedures for investigation and treatment of gynaecological conditions in the office setting is becoming commonplace. Outpatient gynaecological procedures can reduce risks of general anaesthetic, decrease health care costs and make the procedure more convenient for the patient and provider. However, ensuring adequate pain relief and allaying anxiety during the procedure can prove to be challenging. Appropriate patient selection, counselling and adequate pain management during the procedure can improve patient experience and reduce the number of failed procedures.
Common office gynaecological procedures include outpatient hysteroscopy, colposcopy and large loop excision of transformation zone, manual vacuum aspiration for treatment of miscarriages, intrauterine contraceptive device insertion, hysteroscopic sterilisation and endometrial biopsy.
Pain in gynaecological procedures can originate from the cervix and uterus. The uterine fundus is innervated by sympathetic fibres from T10 to L2, which enter through the uterosacral ligaments via the inferior hypogastric plexus, and by nerves from the ovarian plexuses at the cornua. Parasympathetic fibres from S2 to S4 travel through the broad ligament to enter the cervix at the 3 0 clock and 9 o clock positions to provide innervation to the upper vagina, cervix and the lower uterine segment. The pudendal nerve (S 2,3, 4) supplies the lower vagina and vulva.
Physical, psychological and social factors influence the intensity of pain experienced. Counselling the patients pre procedurally helps to better manage expectations and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients: Inclusion criteria will include all women of at least 18 - 70 years of age, planned for an office hysteroscopy.
- •Staff: Inclusion criteria will include the clinician performing the outpatient hysteroscopy and the nurse supporting the clinic.
排除标准
- •Hearing impairments and blindness
- •Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conization, Manchester Fothergill).
- •The denial or withdrawal of oral informed consent Staff: The denial or withdrawal of informed consent
结局指标
主要结局
Worst Pain Scores
时间窗: during the hysteroscopy procedure, an average of 10 minutes
This outcome measure assessed the feasibility of using virtual reality as a distraction technique in the management of acute pain in patients undergoing Outpatient Hysteroscopy. 'Worst pain scores' indicated the most pain experienced during the procedure, even if momentary. It was based on a numeric rating score (11-point scale from 0 to 10; 0 representing 'no pain' and 10 representing 'worst imaginable pain'). The outcome value refers to the worst pain experienced by the participant during the Hysteroscopy procedure.
Average Pain Scores
时间窗: 10 minutes immediately before and after the procedure
This outcome measure assessed the average pain experienced by the participants during the hysteroscopy procedure with virtual reality intervention. The pain scores were based on numeric rating scores (11-point scale from 0 to 10; 0 representing 'no pain' and 10 representing 'worst imaginable pain'). Data from the two time points in the time frame were combined and calculated as an average.
Anxiety Scores
时间窗: during the hysteroscopy procedure, an average of 10 minutes
Anxiety scores were measured on a numeric rating score (scale of 0-10, with 0 representing 'no anxiety' and 10 representing 'worst imaginable anxiety'). The anxiety scores measured during the procedure were reported in this outcome measure.
次要结局
未报告次要终点