Clinical trial NCT03685422: Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery
Official title: The Use of Preoperative Virtual Reality to Reduce Anxiety and Pain on Gynaecologic Patients Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Anxiety
Keywords: Virtual Reality
Pain
Anxiety
Analgesia
Patient satisfaction
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-26
Enrollment: 220
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain scores as assessed by Numeric Rating Scale in both groups
timeFrame: 3 days (post-op Day 1-3)
measure: Quality of recovery as assessed by Quality of Recovery -40 (QoR-40) score in both groups
timeFrame: 3 days (post-op Day 1-3)
Secondary outcomes:
measure: Total consumption of morphine in both groups
timeFrame: 3 days (post-op Day 1-3)
measure: Change in Patient satisfaction as assessed by ordinal scale (VR group only)
timeFrame: 4 days (before surgery till post-op Day 1-3)
measure: Visual analog scale-anxiety (VAS-A) score in both groups
timeFrame: 4 days (before surgery till post-op Day 1-3)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban Leong Sng, MBBS, MMED
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.