Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery

NCT03685422 | Active Not Recruiting DMC

• 1 other identifier: 2018/2200
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Anxiety

Keywords

Virtual Reality; Pain; Anxiety; Analgesia; Patient satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Total consumption of morphine in both groups

  3 days (post-op Day 1-3)

• Change in Patient satisfaction as assessed by ordinal scale (VR group only)

  4 days (before surgery till post-op Day 1-3)

• Visual analog scale-anxiety (VAS-A) score in both groups

  4 days (before surgery till post-op Day 1-3)

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Non Virtual Reality

NO INTERVENTION

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.

Interventions

Virtual Reality OTHER

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.

Virtual Reality

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Only females undergoing gynecologic surgery in KKH will be recruited
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

• 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.

  PMID: 33036555 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Pain; Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ban Leong Sng, MBBS, MMED

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 26, 2018
• Study Start: March 26, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)