Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03685422
• Other study ID #: 2018/2200
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 26, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Hospital Anxiety and Depression Scale (HADS) score in both groups	HADS score will be collected before and after surgery to assess patients' level of anxiety and depression in both VR and non-VR groups. 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.	4 days (before surgery till post-op Day 1-3)