Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery

Overview

In the perioperative setting, distraction therapies have been used as a technique to reduce anxiety and pain in the perioperative period. Measures employed in the local restructured hospitals include television, magazines, and newspapers. Tablet-based activity, music and video distraction therapy have also been shown to be useful to reduce preoperative anxiety. The investigators propose a prospective study to implement and evaluate the use of Virtual Reality (VR) in decreasing in anxiety and pain undergoing gynaecological surgery.

The investigators will administer VR in 100 female adults undergoing day surgery or same-day-admission gynecologic surgery in KK Women's and Children's Hospital (KKH). The VR will be administered using a Samsung Gear VR3 headset fitted with a smartphone. VR images and sound with calming effect will be delivered to the patients for a short duration of about 10 minutes. This low-intensity activity offers soothing experience to distract the patients from any pain and anxiety.

Full Title of Study: “The Use of Preoperative Virtual Reality to Reduce Anxiety and Pain on Gynaecologic Patients Undergoing Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

Studies have shown that the majority of patients undergoing selective surgery experience different levels of anxiety. The degree of anxiety is influenced by factors such as patient demographic characteristics, type of surgery, previous experiences with operational procedures, willingness to undergo the proposed intervention, perceived rapport with hospital personnel and personal stress threshold. This anxiety has been shown to be correlated with acute postoperative pain and chronic postsurgical pain, which leads to an increased use of postoperative analgesic, slow recovery, and other maladaptation behaviours in paediatric patient like eating disorders. The link between greater preoperative anxiety and the risk for developing chronic postsurgical pain has been documented in a variety of surgical procedures, including elective abdominal hysterectomy, radical mastectomy, breast cancer surgery, and arthroscopic knee surgery. While pharmacological interventions such as opioid-based analgesic are available, other methods to manage anxiety and distract patients from stressors – such as music, television, and virtual reality – have become more popular in the recent years due to their safety, low cost and effectiveness in improving overall patient experience and outcome.

Virtual reality (VR) is a promising new technology that offers opportunities to modulate pain experience and cognition. Patients received VR treatment reported a reduction in pain and anxiety, faster wound healing, decreased chronic pain intensity and other neurorehabilitation improvements. The recent advent of inexpensive consumer VR system has also made VR more accessible to the mass, especially those by Samsung available locally. In SingHealth, VR has been used in neurosurgery for individualized surgery planning for patients with brain tumours, vascular malfunction and skull based tumours. However, there has been little done to investigate the effectiveness of VR during the preoperative period especially in local setting. Therefore, the investigators will investigate the feasibility and practicability of employing VR in anxiety and pain management in patients undergoing same day admission or day surgery. The proposed intervention may not only be implemented in the preoperative environment but also be in other settings such as before diagnostic screening or minor treatments done during inpatient stay or outpatient visit. The use of VR is suitable for those who are preparing for procedures in clinic or ward as an alternative anxiety management without prolonging the preparation time.

Interventions

  • Other: Virtual Reality
    • Before surgery, consented patients are given a Virtual Reality headset with pre-installed relaxation apps to choose a preferred scenario. Patient will be asked on their satisfaction on the VR experience after the intervention. Hospital Anxiety and Depression Scale (HADS), Spielberger State-Trait Anxiety Inventory (STAI) and EQ-5D-3L questionnaires will be conducted during this period.

Arms, Groups and Cohorts

  • Experimental: Virtual Reality
    • Patient will be given a Samsung Gear VR3 headset fitted with a smartphone. She will choose the desired playlist on calming scenario and experience the Virtual Reality (VR) for about 10 minutes, seated in a quiet environment in pre-operative waiting area before her turn for the scheduled surgery. Patient will be asked on their satisfaction on the VR experience after the intervention. Questionnaires will be conducted during this period. During and after the gynecologic surgery, baseline demographic data and analgesia usage will be recorded. Patient will be sent to the recovery room after the surgery, and the study team members will collect their questionnaire scorings. All the headsets will be disinfected following the hospital’s infection control guideline.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Pain score as assessed by Numeric Rating Scale
    • Time Frame: 1 day (before and after surgery)
    • Difference of pain score before and after surgery. Pain scores (on a numeric rating scale 0-10) will be given to patients, with 0 being no pain and 10 being the worst pain possible.

Secondary Measures

  • Total consumption of morphine
    • Time Frame: 1 day (after surgery)
    • Morphine (in milligrams) used after surgery will be recorded.
  • Change in Patient satisfaction as assessed by ordinal scale
    • Time Frame: 5 minutes (before and after surgery)
    • Patient will be asked on their satisfaction level before and after the use of VR based on ordinal scale (excellent, good, fair, poor).
  • Change in Hospital Anxiety and Depression Scale (HADS) score
    • Time Frame: 1 day (Before surgery and after patient is discharged from recovery room)
    • HADS score will be collected before and after surgery to assess patients’ level of anxiety and depression. Each item on the questionnaire is scored from 0 to 3, thus a patient might have a total score from 0 to 21 for the overall questionnaire. A score of 0-7 indicates normal level of anxiety/depression while 8-10 indicates borderline abnormal (borderline case) and 11-21 indicates abnormal case.
  • Change in EQ-5D-3L score
    • Time Frame: 1 day (Before surgery and after patient is discharged from recovery room)
    • EQ-5D-3L is a standardized instrument for measuring generic health status. The two components of the Score are health state description and evaluation. The health status is measured in terms of five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranges from 1 to 3. From these dimensions, EQ-5D index is calculated, having a value between 0 and 1. The evaluation component involves an analogue scale, asking to mark health status on the day of interview on a 20 cm vertical scale with end point of 0 and 100. Zero corresponds to “the worst health you can imagine” and hundred corresponds to “the best health you can imagine”.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy participants who are ASA 1 & 2 (with well-controlled medical problems)
  • Undergo day surgery or same-day -admission gynecologic surgery
  • Have no visual impairment

Exclusion Criteria

  • Patients with significant respiratory disease and obstructive sleep apnea
  • Patient who are unable to understand questionnaire
  • Obstetric patients
  • Patients with motion sickness in 3D environment

Gender Eligibility: Female

Only females undergoing gynecologic surgery in KKH will be recruited

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • KK Women’s and Children’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ban Leong Sng, MBBS, MMED, Principal Investigator, KK Women’s and Children’s Hospital

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