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Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery

Primary Purpose

Pain, Postoperative, Anxiety

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Virtual Reality, Pain, Anxiety, Analgesia, Patient satisfaction

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Non Virtual Reality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Total consumption of morphine in both groups
Difference in Morphine (in milligrams) used after surgery between virtual reality (VR) and non-VR groups.
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).
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.

Full Information

First Posted
August 22, 2018
Last Updated
April 2, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03685422
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anxiety
Keywords
Virtual Reality, Pain, Anxiety, Analgesia, Patient satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Non Virtual Reality
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain scores as assessed by Numeric Rating Scale in both groups
Description
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.
Time Frame
3 days (post-op Day 1-3)
Title
Quality of recovery as assessed by Quality of Recovery -40 (QoR-40) score in both groups
Description
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).
Time Frame
3 days (post-op Day 1-3)
Secondary Outcome Measure Information:
Title
Total consumption of morphine in both groups
Description
Difference in Morphine (in milligrams) used after surgery between virtual reality (VR) and non-VR groups.
Time Frame
3 days (post-op Day 1-3)
Title
Change in Patient satisfaction as assessed by ordinal scale (VR group only)
Description
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).
Time Frame
4 days (before surgery till post-op Day 1-3)
Title
Hospital Anxiety and Depression Scale (HADS) score in both groups
Description
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.
Time Frame
4 days (before surgery till post-op Day 1-3)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females undergoing gynecologic surgery in KKH will be recruited
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng, MBBS, MMED
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33036555
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.
Results Reference
derived

Learn more about this trial

Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery

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