VR as a Distraction Technique for Management of Acute Anxiety and Pain During Outpatient Colposcopy Procedures - a Single Centre Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Anxiety level
研究概览
简要总结
Colposcopy is an extremely important part of womens healthcare in the prevention of cervical cancer. Women report feeling extremely anxious attending colposcopy, due to the association with cancer and the intimate nature of the examination.
The goal of this clinical trial is to investigate where the use of virtual reality headsets during outpatient colposcopy appointments has any effect on womens' experience. The main question[s] it aims to answer are:
- Does the use of virtual reality headsets reduce anxiety in patients attending colposcopy
- Does the use of virtual reality headsets reduce pain in patients attending colposcopy
Patients will offered to enroll in the trial when they attend for their colposcopy appointment.
Participants will fill out a questionnaire to measure their anxiety beforehand and collect patient demographics.
They will be randomly allocated into the intervention arm or the control arm. This means they will either use virtual reality headset in addition to the standard care, or have standard colposcopy care only After their colposcopy, they will then be asked to to fill out another questionnaire to measure anxiety and pain levels.
If there is a comparison group: Researchers will compare the results from the women who had colposcopy while using the virtual reality headsets to women to see if there is any meaningful difference in anxiety while using the virtual reality headsets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participants will be blindly randomly allocation to the control or intervention arm, however due to the nature of the study it will not be possible to blind the participant or assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women over 18 years of age who attend for outpatient colposcopy and provide informed written consent
- •Have completed colposcopy training and be a registered member of the British Society of Colposcopy and Cervical Pathology (BSCCP)
- •Informed written consent to take part in the trial.
排除标准
- •Patients :
- •Significant hearing or visual impairments that may effect communication
- •Any known characteristics that may make the office procedure more difficult (eg. previous LLETZ, previous cervical conisation, uterine didelphis)
- •Inability to provide consent.
- •Denial or withdrawal of informed consent orally
- •The denial or withdrawal of informed consent.
- •Trainee colposcopist performing clinic.
研究组 & 干预措施
Control Arm : Standard colposcopy care
Women in the control arm will be offered all aspects of standard colposcopy care for their pain relief. This includes : nursing support, local anaesthetic and gas and air as required.
Virtual reality headsets as a distraction method
The patient will attend for colposcopy at which the consultation will begin as normal. When the time comes for examination +/- biopsy +/- treatment, the patient will be offered the virtual reality headset as a form of immersive therapy to distract them during the procedure. This will be continued until cessation of examination. All other standard forms of pain relief will also be provided for the patient.
干预措施: Virtual Reality Headsets (Device)
结局指标
主要结局
Anxiety level
时间窗: Before colposcopy and within 15 minutes after the procedure
Modified State Trait Anxiety Index scores (STAI) will be assessed both prior to colposcopy and afterwards. STAI scores is a validated questionaire for measurement of anxiety. It consists of 5 questions with participants self reporting scores. Questions include "I feel frightened," "I feel jittery," " I feel upset," "I feel nervous" and "I feel confused." Outcomes include "Not at all," "Somewhat," "Moderately so" and "very much so." These are scored 1 -4. Total scores will range from 5 to 20, with high scores indicating a higher state of anxiety.
次要结局
- Pain level(Within 15 minutes following the procedure)