A Multi-site Randomised Controlled Trial Assessing the Effectiveness of the Little Journey App at Reducing Peri-operative Anxiety Compared to Standard Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 18
- 主要终点
- Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
研究概览
简要总结
To evaluate the clinical effectiveness of a virtual reality psychological preparation app at reducing peri-operative anxiety and its associated sequelae in children aged 3-12 years old undergoing ambulatory surgery compared to standard care.
详细描述
This is a phase III multi-centre randomised controlled trial evaluating the effectiveness of the Little Journey app: a pre-hospital psychological preparation tool designed for children undergoing ambulatory surgery.
Participants are pre-screened virtually through assessment of those placed on a waiting list for day case surgery at participating sites. Due to the Covid-19 pandemic, preoperative assessment clinic appointments for children undergoing ambulatory surgery have in general, moved from face-to-face appointments to telephone consultations. To enable consent and enrolment of suitable participants undergoing either telephone or face-to-face preoperative assessment, two consent pathways were developed:
Pathway 1: Remote consent. Participants are pre-screened virtually through assessment of those placed on a waiting list for day case surgery at participating sites. Pre-screening is based on the age of the child, and contingent on there being a minimum of 9 days between telephone consent and the day of planned surgery. This window has been developed to provide a minimum of 5 days of potential use time for the Little Journey app (allowing 2-3 days for the headset to arrive with the participant).
All eligible participants' parents/carers are sent a participation information sheet at least 48 hours before being approached for consent, and a copy of the consent form, by email or post. Children are also sent an information leaflet tailored to their age. A minimum of 3 working days will be provided to the parent / carer, between the research team sending them the PIS and subsequently being approached for telephone consent. Telephone consent follows a pre-approved script with opportunity provided for the parent/carer to ask questions. Families are provided with a copy of the consent form to refer to during the conversation. Telephone consent is documented on stage one of the consent form and placed in the patient notes. Written confirmation of consent (stage 2 of the consent form) is sought when the patient and carer come to hospital for surgery and before the time of transfer from the ward/outpatient are to the operating department. A copy of the signed consent form is provided to the participant's parent/carer and in the clinical notes; the original is retained in the investigator site file.
If available, at the time of consent, an assent form will be completed for children aged between 8 and 12 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 3-12 years of age on the date of parental consent to participate in the trial
- •Those undergoing surgery planned to be conducted as a day-case (surgery is defined as any therapeutic procedure taking place under the care of an anaesthetist and surgeon or dentist)
- •Requiring general anaesthetic (must be their first general anaesthetic)
- •Both child and parent able to speak / understand one of the languages available on the app
- •American Society of Anesthesiologists' physical status class I-III
- •Class I: A normal healthy patient
- •Class II: A patient with mild systemic disease
- •Class III: A patient with severe systemic disease
- •Note: Surgery is defined as any procedure occurring in a theatre under the care of a surgeon or dentist and an anaesthetist.
排除标准
- •Children aged less than 3 years of age or more than 12 years' old on the date of parental consent
- •Any child and/or parent that refuses to be part of the study
- •Patients and parents who do not speak one of the languages which are available on the app
- •Children undergoing diagnostic procedures (e.g. scans, cardiac catheterisation)
- •Any child with a visual or hearing impairments significant enough to prevent use of the intervention as decided on case-by-case basis.
- •American Society of Anesthetists physical status class IV-VI
- •Class IV: A patient with severe systemic disease that is a constant threat to life.
- •Class V: A moribund patient who is not expected to survive without the operation.
研究组 & 干预措施
Standard Care arm
Participants will receive standard of care from the pre-assessment clinic until discharge.
A typical preparatory National Health Service pathway would include: meeting a specialist nurse in the preoperative assessment clinic; a preoperative anaesthetic and surgical consultation; interaction with health play specialists on the day of surgery; and distraction interventions such as hand-held tablets during induction of anaesthesia. Participants may have inhalation or intravenous induction depending on the primary management plan of the anaesthetist in charge.
Participants in the standard care arm will also receive a virtual reality cardboard headset, which can be taken home, personalised and decorated before use with virtual reality apps available to download from the app stores.
Intervention arm
Participants allocated to the intervention arm will receive the same peri-operative management as the standard care arm and will also receive an access code enabling them to use the Little Journey app in the weeks leading up to their operation. We suggest the Little Journey app is used in the days to weeks leading up to the child's operation depending on their age. On downloading the app, if parents/carers insert the age of the child and date of surgery into the Little Journey app they will be sent a push notifications reminding them when to use it according to their child's age. However, it can be used as frequently as the child and/or their parents or carers wish before the operation.
干预措施: Little Journey app (Device)
结局指标
主要结局
Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)
时间窗: Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room
An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety.
次要结局
- Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)(Day of Surgery (Day 1): Measured on the ward prior to surgery)
- VAS - Parent Anxiety (VAS-PA)(Day of surgery (Day 1): Measured immediately following observation of the induction of anaesthesia.)
- VAS - Satisfaction with pre-operative information (VAS-SI)(Day of Surgery (Day 1): Measured on the ward prior to the operation on the day of surgery.)
- VAS - Compliance(Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia)
- VAS Distress(Day of surgery (Day 1): Recorded immediately following observation of the induction of anaesthesia)
- Time to induction(Day of surgery (Day 1): Measured from entry into the anaesthetic room to entry into theatre.)
- Analgesic use(Day of surgery (Day 1): Recorded in the recovery room following surgery)
- Anti-emetic use(Day of surgery (Day 1): Recorded in the recovery room following surgery)
- Time to recovery(Day of surgery (Day 1): Measured from patients arrival in the recovery room until deemed ready for discharge.)
- VAS- Parent satisfaction with care(Day of surgery (Day 1): Measured on the ward prior to discharge home following surgery.)
- Time to discharge(Day of surgery (Day 1): Recorded at end of day of surgery following discharge.)
- Unplanned cancellations(Day of surgery (Day 1): recorded prior to attempt of induction of anaesthesia)
- Adverse events questionnaire(Day of Surgery (Day 1): Non-validated questionnaire completed immediately prior to discharge from hospital)
- Unplanned admissions(Day of surgery (Day 1): Recorded at end of day of surgery)
- Post Hospital Behavioural Questionnaire(Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians)
- Number of days of work/school missed(Day 28 post surgery: Completed at four-weeks after surgery by telephone consultation with parents/guardians)