Pain, AcuteNCT06463210
Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy
A study testing Virtual reality as a distraction technique in people with Pain, Acute and Satisfaction, Patient, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH). 60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Satisfaction, Patient
- What is being tested?
- Virtual reality as a distraction technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive women candidates to undergo an OH
- Women aged 18 to 70 years old
Who cannot join
- Visual impairment
- Hearing impairment
- Language barrier impeding the correct explanation of the study
- Contraindication for using the VR device
- Confirmed malignant endometrial disease
- Anatomical characteristics impeding the office hysteroscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: a Randomized Controlled Trial
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.
The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH
Read the detailed description
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
In the standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.
The standard care group had a trained nurse providing distraction and emotional support.
The study group had a VR device (Meta Quest 2) with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH, comparing it with the standard care group.
- Conditions
- Pain, Acute, Satisfaction, Patient
- Being tested
- Virtual reality as a distraction technique
- Keywords
- Hysteroscopy
- Medical subject headings
- Acute Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality as a distraction techniqueDevice
A 360º relaxing video with music was displayed through a VR headset
| Study group | Role | What they receive |
|---|---|---|
| Nurse support during hysteroscopy: control group | No intervention | In our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious. As part of our standard procedure during the OH, a trained nurse with >10 years of experience provides distraction and emotional support to the woman. She explains the patient how to breathe and what to expect during the different moments of the procedure, thus involving the women directly in what is happening during the procedure. |
| Virtual reality during hysteroscopy: study group | Experimental | In our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.
A 360º video was administered to the study group through an Oculus Quest 2™ headset (Meta Platforms, CA. USA). The video was administered through the headset just before the start of the procedure. The video chosen showed a gondola ride through the canals of Venice with relaxing music played on the headset Receives: Device: Virtual reality as a distraction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak pain
a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure, being 0 no pain and 10 worst pain imaginable
Measured: 5-10 minutes after the procedure
Mean pain
a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable
Measured: 5-10 minutes after the procedure
Secondary outcomes (4)
Patient satisfaction with the information received
Prior to the OH all patients were interrogated about their perception of the information received about the procedure through the question "How has been the information received about the procedure?" (Not enough/Normal/Very good
Measured: 5-10 min before the procedure
Patient overall satisfaction with the procedure (OH)
Overall satisfaction with the OH was assessed through a question formulated as follows: "What is your level of satisfaction with the hysteroscopic procedure?", where patients could evaluate their opinion on a 5-point scale (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied
Measured: 5-10 min after the procedure
Patient satisfaction with the VR intervention
On the study group, patient satisfaction with the VR intervention was also assessed with the following 5-point scale satisfaction question "What is your level of satisfaction with the VR intervention? (Very satisfied, Fairly satisfied, Neutral, Somewhat unsatisfied, Very unsatisfied
Measured: 5-10 min after the procedure
Patient satisfaction with the VR intervention
Patients on the VR group were also asked whether they would like to use the VR if they need to undergo another OH in the future (Yes/No)
Measured: 5-10 min after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- Model description
- 2 randomized groups with 60 patients per arm
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463210
- Sponsor's protocol ID
- VRHSC 21/278
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If needed for further studies and with the previous evaluation of the investigators IPD would be available to other researchers
Publications
Vitagliano A, Dellino M, Favilli A, D' Amato A, Nicoli P, Lagana AS, Noventa M, Bochicchio MA, Cicinelli E, Damiani GR. Patients' Use of Virtual Reality Technology for Pain Reduction during Outpatient Hysteroscopy: A Meta-analysis of Randomized Controlled Trials. J Minim Invasive Gynecol. 2023 Nov;30(11):866-876. doi: 10.1016/j.jmig.2023.08.427. Epub 2023 Aug 29.
PubMed 37648150Deo N, Khan KS, Mak J, Allotey J, Gonzalez Carreras FJ, Fusari G, Benn J. Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Jan;128(1):87-95. doi: 10.1111/1471-0528.16377. Epub 2020 Jul 22.
PubMed 32575151Baradwan S, Alshahrani MS, AlSghan R, Alyafi M, Elsayed RE, Abdel-Hakam FA, Moustafa AA, Hussien AE, Yahia OS, Shama AA, Magdy AA, Abdelhakim AM, Badran H. The effect of virtual reality on pain and anxiety management during outpatient hysteroscopy: a systematic review and meta-analysis of randomized controlled trials. Arch Gynecol Obstet. 2024 Apr;309(4):1267-1280. doi: 10.1007/s00404-023-07319-8. Epub 2024 Jan 2.
PubMed 38165441Cohen N, Nasra LA, Paz M, Kaufman Y, Lavie O, Zilberlicht A. Pain and anxiety management with virtual reality for office hysteroscopy: systemic review and meta-analysis. Arch Gynecol Obstet. 2024 Apr;309(4):1127-1134. doi: 10.1007/s00404-023-07261-9. Epub 2023 Nov 2.
PubMed 37917158Pelazas-Hernandez JA, Varillas-Delgado D, Gonzalez-Casado T, Cristobal-Quevedo I, Alonso-Bermejo A, Ronchas-Martinez M, Cristobal-Garcia I. The Effect of Virtual Reality on the Reduction of Pain in Women with an Indication for Outpatient Diagnostic Hysteroscopy: A Randomized Controlled Trial. J Clin Med. 2023 May 24;12(11):3645. doi: 10.3390/jcm12113645.
PubMed 37297840Sewell T, Fung Y, Al-Kufaishi A, Clifford K, Quinn S. Does virtual reality technology reduce pain and anxiety during outpatient hysteroscopy? A randomised controlled trial. BJOG. 2023 Nov;130(12):1466-1472. doi: 10.1111/1471-0528.17550. Epub 2023 May 23.
PubMed 37218438Fouks Y, Kern G, Cohen A, Reicher L, Shapira Z, Many A, Yogev Y, Rattan G. A virtual reality system for pain and anxiety management during outpatient hysteroscopy-A randomized control trial. Eur J Pain. 2022 Mar;26(3):600-609. doi: 10.1002/ejp.1882. Epub 2021 Nov 23.
PubMed 34748679Mirza E, Hanif M, Khan MA, Jaleel S. Re: Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Mar;128(4):769-770. doi: 10.1111/1471-0528.16500. Epub 2020 Oct 7. No abstract available.
PubMed 33027546Olloqui A, Tejerizo-Garcia A, Guillen C, Perez-Sagaseta C, Gonzalez-Macho C, Bolivar-Miguel AB, Villalba-Gutierrez A, Gil-Ibanez B. Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: A Randomised Controlled Trial. BJOG. 2025 Sep;132(10):1416-1425. doi: 10.1111/1471-0528.18228. Epub 2025 May 21.
PubMed 40400089
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06463210
- Acronym / sponsor ID
- VRHSC 21/278
- Conditions
- Pain, Acute, Satisfaction, Patient
- Keywords
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Jun 2024 (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.
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.
The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH
Detailed description
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
In the standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.
The standard care group had a trained nurse providing distraction and emotional support.
The study group had a VR device (Meta Quest 2) with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH, comparing it with the standard care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 randomized groups with 60 patients per arm
| Arm | Type | Receives |
|---|---|---|
| Nurse support during hysteroscopy: control group | No intervention | –In our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious. As part of our standard procedure during the OH, a trained nurse with >10 years of experience provides distraction and emotional support to the woman. She explains the patient how to breathe and what to expect during the different moments of the procedure, thus involving the women directly in what is happening during the procedure. |
| Virtual reality during hysteroscopy: study group | Experimental | Device: Virtual reality as a distraction techniqueIn our standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious. A 360º video was administered to the study group through an Oculus Quest 2™ headset (Meta Platforms, CA. USA). The video was administered through the headset just before the start of the procedure. The video chosen showed a gondola ride through the canals of Venice with relaxing music played on the headset |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive women candidates to undergo an OH
- Women aged 18 to 70 years old
Key exclusion criteria (6 listed)
- Visual impairment
- Hearing impairment
- Language barrier impeding the correct explanation of the study
- Contraindication for using the VR device
- Confirmed malignant endometrial disease
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 reality as a distraction techniqueA 360º relaxing video with music was displayed through a VR headset | Device | Virtual reality during hysteroscopy: study group |
Primary outcome
Peak pain
Time frame: 5-10 minutes after the procedure
a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure, being 0 no pain and 10 worst pain imaginable
Mean pain
Time frame: 5-10 minutes after the procedure
a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable
4 secondary outcomes
Patient satisfaction with the information received
Time frame: 5-10 min before the procedure
Patient overall satisfaction with the procedure (OH)
Time frame: 5-10 min after the procedure
Patient satisfaction with the VR intervention
Time frame: 5-10 min after the procedure
Patient satisfaction with the VR intervention
Time frame: 5-10 min after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Background: PubMed 37648150Vitagliano A, Dellino M, Favilli A, D' Amato A, Nicoli P, Lagana AS, Noventa M, Bochicchio MA, Cicinelli E, Damiani GR. Patients' Use of Virtual Reality Technology for Pain Reduction during Outpatient Hysteroscopy: A Meta-analysis of Randomized Controlled Trials. J Minim Invasive Gynecol. 2023 Nov;30(11):866-876. doi: 10.1016/j.jmig.2023.08.427. Epub 2023 Aug 29.
- Background: PubMed 32575151Deo N, Khan KS, Mak J, Allotey J, Gonzalez Carreras FJ, Fusari G, Benn J. Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Jan;128(1):87-95. doi: 10.1111/1471-0528.16377. Epub 2020 Jul 22.
- Background: PubMed 38165441Baradwan S, Alshahrani MS, AlSghan R, Alyafi M, Elsayed RE, Abdel-Hakam FA, Moustafa AA, Hussien AE, Yahia OS, Shama AA, Magdy AA, Abdelhakim AM, Badran H. The effect of virtual reality on pain and anxiety management during outpatient hysteroscopy: a systematic review and meta-analysis of randomized controlled trials. Arch Gynecol Obstet. 2024 Apr;309(4):1267-1280. doi: 10.1007/s00404-023-07319-8. Epub 2024 Jan 2.
- Background: PubMed 37917158Cohen N, Nasra LA, Paz M, Kaufman Y, Lavie O, Zilberlicht A. Pain and anxiety management with virtual reality for office hysteroscopy: systemic review and meta-analysis. Arch Gynecol Obstet. 2024 Apr;309(4):1127-1134. doi: 10.1007/s00404-023-07261-9. Epub 2023 Nov 2.
- Background: PubMed 37297840Pelazas-Hernandez JA, Varillas-Delgado D, Gonzalez-Casado T, Cristobal-Quevedo I, Alonso-Bermejo A, Ronchas-Martinez M, Cristobal-Garcia I. The Effect of Virtual Reality on the Reduction of Pain in Women with an Indication for Outpatient Diagnostic Hysteroscopy: A Randomized Controlled Trial. J Clin Med. 2023 May 24;12(11):3645. doi: 10.3390/jcm12113645.
- Background: PubMed 37218438Sewell T, Fung Y, Al-Kufaishi A, Clifford K, Quinn S. Does virtual reality technology reduce pain and anxiety during outpatient hysteroscopy? A randomised controlled trial. BJOG. 2023 Nov;130(12):1466-1472. doi: 10.1111/1471-0528.17550. Epub 2023 May 23.
- Background: PubMed 34748679Fouks Y, Kern G, Cohen A, Reicher L, Shapira Z, Many A, Yogev Y, Rattan G. A virtual reality system for pain and anxiety management during outpatient hysteroscopy-A randomized control trial. Eur J Pain. 2022 Mar;26(3):600-609. doi: 10.1002/ejp.1882. Epub 2021 Nov 23.
- Background: PubMed 33027546Mirza E, Hanif M, Khan MA, Jaleel S. Re: Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Mar;128(4):769-770. doi: 10.1111/1471-0528.16500. Epub 2020 Oct 7. No abstract available.
- Derived from this study: PubMed 40400089Olloqui A, Tejerizo-Garcia A, Guillen C, Perez-Sagaseta C, Gonzalez-Macho C, Bolivar-Miguel AB, Villalba-Gutierrez A, Gil-Ibanez B. Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: A Randomised Controlled Trial. BJOG. 2025 Sep;132(10):1416-1425. doi: 10.1111/1471-0528.18228. Epub 2025 May 21.
- Individual participant dataSharing planned: Undecided. If needed for further studies and with the previous evaluation of the investigators IPD would be available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 as a distraction technique in people with Pain, Acute and Satisfaction, Patient, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jul 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak pain (time frame: 5-10 minutes after the procedure). 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 NCT06463210, which also lists 9 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 5 Jul 2024.