Pain, PostoperativeNCT03685422
Preoperative Virtual Reality to Reduce Pain on Gynaecologic Patients Undergoing Surgery
A study testing Virtual Reality in people with Pain, Postoperative and Anxiety, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Pain, Postoperative, Anxiety
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Mar 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative, Anxiety
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Pain, Anxiety, Analgesia, Patient satisfaction
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Pain, Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 days (post-op Day 1-3)
Secondary outcomes (3)
Total consumption of morphine in both groups
Difference in Morphine (in milligrams) used after surgery between virtual reality (VR) and non-VR groups.
Measured: 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).
Measured: 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.
Measured: 4 days (before surgery till post-op Day 1-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start26 Mar 2019
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban Leong Sng, MBBS, MMED, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685422
- Sponsor's protocol ID
- 2018/2200
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2018
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan JJI, Sultana R, Ho YTR, Al Malki MHS, Tan CW, Sng BL. The use of virtual reality to improve quality of recovery in women undergoing gynecological surgeries: a randomized controlled trial. Sci Rep. 2026 Mar 5;16(1):12261. doi: 10.1038/s41598-026-41984-4.
PubMed 41787026Chan 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.
PubMed 33036555
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Preoperative Virtual Reality to Reduce Anxiety and Pain on Gynaecologic Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT03685422
- Acronym / sponsor ID
- 2018/2200
- Conditions
- Pain, Postoperative, Anxiety
- Keywords
- Virtual Reality, Pain, Anxiety, Analgesia, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual RealityPatients 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. |
| 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityBefore 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. | Other | Virtual Reality |
Primary outcome
Pain scores as assessed by Numeric Rating Scale in both groups
Time frame: 3 days (post-op Day 1-3)
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
Time frame: 3 days (post-op Day 1-3)
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 secondary outcomes
Total consumption of morphine in both groups
Time frame: 3 days (post-op Day 1-3)
Change in Patient satisfaction as assessed by ordinal scale (VR group only)
Time frame: 4 days (before surgery till post-op Day 1-3)
Visual analog scale-anxiety (VAS-A) score in both groups
Time frame: 4 days (before surgery till post-op Day 1-3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 41787026Chan JJI, Sultana R, Ho YTR, Al Malki MHS, Tan CW, Sng BL. The use of virtual reality to improve quality of recovery in women undergoing gynecological surgeries: a randomized controlled trial. Sci Rep. 2026 Mar 5;16(1):12261. doi: 10.1038/s41598-026-41984-4.
- Derived from this study: PubMed 33036555Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban Leong Sng, MBBS, MMED principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pain, Postoperative and Anxiety, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores as assessed by Numeric Rating Scale in both groups (time frame: 3 days (post-op Day 1-3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685422, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.