Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery

The Use of Preoperative Virtual Reality to Reduce Anxiety and Pain on Gynaecologic Patients Undergoing Surgery

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.

In the first phase of study, VR will be administered in 110 female adults undergoing day surgery, same-day-admission or in-patient gynecologic surgery in 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 up to 25 minutes. This low-intensity activity offers soothing experience to distract the patients from any pain and anxiety. Second phase of study will randomize 110 female adults undergoing gynecologic surgery. Pain and psychological assessment will be conducted after recruitment, and the group assigned to VR group will navigate the VR environment before and after surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain, Postoperative; Anxiety
• Intervention / Treatment: Other: Virtual Reality

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Patients will be given a VR Gear Headset fitted with a smartphone, and will be offered to choose the calming scenario they wish to experience from a set of predefined scenarios before the surgery. They will be given time to experience VR for up to 25 mins. After the VR session, patients will be given questionnaires, satisfaction with VR, and pain scores. After the surgery is completed, patient will be transferred to recovery room. Patients may resume VR session for up to 25 mins. After the use of VR, they will be asked on their satisfaction towards the VR experience, and also fill in questionnaires. On the same day of surgery (0-24 hours post-op), patients will be asked to have another two more VR sessions (up to 25 mins per session), with questionnaire filled in after the sessions. On the second day and third day of the surgery (48-72 hours post-op), questionnaires will be given. All the headsets will be disinfected following the hospital's infection control guideline.	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. Visual analog scale-anxiety (VAS-A), Spielberger State-Trait Anxiety Inventory (STAI) and EQ-5D-3L questionnaires will be conducted during this period.
No Intervention: Non Virtual Reality; Before the surgery, only questionnaires and pain scores will be documented. After the surgery is completed, patient will be transferred to recovery room. Only questionnaires and pain scores will be documented. On the second day and third day of the surgery (48-72 hours post-op), questionnaires will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores as assessed by Numeric Rating Scale in both groups	Difference in pain scores between virtual reality (VR) and non-VR groups. 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.	3 days (post-op Day 1-3)
Quality of recovery as assessed by Quality of Recovery -40 (QoR-40) score in both groups	Difference in QoR-40 between virtual reality (VR) and non-VR groups. The QoR-40 is a global measure of quality of recovery. It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).	3 days (post-op Day 1-3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total consumption of morphine in both groups	Difference in Morphine (in milligrams) used after surgery between virtual reality (VR) and non-VR groups.	3 days (post-op Day 1-3)
Change in Patient satisfaction as assessed by ordinal scale (VR group only)	Patients assigned to VR group will be asked on their satisfaction level before and after the use of VR based on ordinal scale (excellent, good, fair, poor).	4 days (before surgery till post-op Day 1-3)
Visual analog scale-anxiety (VAS-A) score in both groups	VAS-A score will be collected before and after surgery to assess patients' level of anxiety in both VR and non-VR groups. VAS-A scores from 0 to 10, with 0 being no anxiety and 10 being the greatest anxiety. Higher score indicates a greater level of anxiety.	4 days (before surgery till post-op Day 1-3)

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Ban Leong Sng, MBBS, MMED, KK Women's and Children's Hospital

Publications and helpful links

General Publications

• Chan JJI, Yeam CT, Kee HM, Tan CW, Sultana R, Sia ATH, Sng BL. The use of pre-operative virtual reality to reduce anxiety in women undergoing gynecological surgeries: a prospective cohort study. BMC Anesthesiol. 2020 Oct 9;20(1):261. doi: 10.1186/s12871-020-01177-6.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Patient satisfaction; Pain; Anxiety; Analgesia; Virtual Reality
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: 2018/2200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No