Acute PainNCT06424093
Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy
A study testing Virtual Reality Technology in people with Acute Pain and Anxiety, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Acute Pain, Anxiety
- What is being tested?
- Virtual Reality Technology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 15 Nov 2024
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for diagnostic hysteroscopy e.g. Infertility, AUB
Who cannot join
- Absolute contraindication to office hysteroscopy such as acute pelvic infection , active genital herpes , heavy bleeding or pregnancy.
- Psychological ,hearing or visual disorders.
- known anatomical condition that make performing office hysteroscopy is difficult such as cervical stenosis ,fibrosis or cervical amputation .
- Previous history of failed office hysteroscopy
- Patients scheduled for operative hysteroscopy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo
Ahmed Eid Elsayed Zidan, MSc, +201067845518, dr.a.zidan87@gmail.com
Joseph Adel Ibrahim, MSc, +201285515950, joseph.johny2010@gmail.com
About this study
Official title: Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider.
Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset.
Read the detailed description
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. Such procedures are usually well tolerated , However it can be associated with acute pain and anxiety. Options of Pain relief include sedation, local anaesthetic , analgesics and distraction techniques, however no consistent good quality evidence exists to support practice.
Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset. The obstacles of cost, quality and accessibility of (VR) devices have significantly eliminated in recent years and offer promising application in the medical field. Virtual reality for managing pain has been studied in many fields including paediatrics, dentistry, burns treatment, chronic pain, labour, and episiotomy.
Although a meta-analysis suggested that VR may have a role in reducing pain scores in acutely painful interventions , studies found it to be effective only in needles and burns physical therapy.
The studies of VR on pain and anxiety, however, were limited by clinical and statistical heterogeneity.
Nonpharmacological options of pain relief have not explored enough the role of VR in reducing pain and improving patient experience in outpatient hysteroscopy .To our knowledge, there is only one publication studying the role of virtual reality in the management of acute pain during office gynaecological procedures
- Conditions
- Acute Pain, Anxiety
- Being tested
- Virtual Reality Technology
- Keywords
- hysteroscopy, Acute Pain, Anxiety, Virtual Reality
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TechnologyProcedure or surgery
Also called Hysteroscopy
To evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cases Group | Experimental | About 25 women indicated for diagnostic hysteroscopy with using Virtual Reality Technology Receives: Procedure: Virtual Reality Technology |
| Group B: Control Group | Placebo comparator | About 25 women indicated for diagnostic hysteroscopy without using Virtual Reality Technology Receives: Procedure: Virtual Reality Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain
The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)
Measured: 10 minutes from starting the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 May 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amr Elhussieny, Professor, Study chair, Head of Obstetrics and Gynecology department , Faculty of Medicine, Ain Shams UniversityMortada El Sayed Ahmed, Professor, Study director, Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams UniversityRadwa Rsaheedy Ali, M.D, Principal investigator, Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424093
- Sponsor's protocol ID
- Virtual Reality Technology
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Technology for Managment of Acute Pain in Outpatient Hysteroscopy: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06424093
- Acronym / sponsor ID
- Virtual Reality Technology
- Conditions
- Acute Pain, Anxiety
- Keywords
- hysteroscopy, Acute Pain, Anxiety, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 21 May 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.
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider.
Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset.
Detailed description
Performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. Such procedures are usually well tolerated , However it can be associated with acute pain and anxiety. Options of Pain relief include sedation, local anaesthetic , analgesics and distraction techniques, however no consistent good quality evidence exists to support practice.
Virtual reality (VR), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. It is a computer-generated representation of an immersive videos viewed through a headset. The obstacles of cost, quality and accessibility of (VR) devices have significantly eliminated in recent years and offer promising application in the medical field. Virtual reality for managing pain has been studied in many fields including paediatrics, dentistry, burns treatment, chronic pain, labour, and episiotomy.
Although a meta-analysis suggested that VR may have a role in reducing pain scores in acutely painful interventions , studies found it to be effective only in needles and burns physical therapy.
The studies of VR on pain and anxiety, however, were limited by clinical and statistical heterogeneity.
Nonpharmacological options of pain relief have not explored enough the role of VR in reducing pain and improving patient experience in outpatient hysteroscopy .To our knowledge, there is only one publication studying the role of virtual reality in the management of acute pain during office gynaecological procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Cases Group | Experimental | Procedure: Virtual Reality TechnologyAbout 25 women indicated for diagnostic hysteroscopy with using Virtual Reality Technology |
| Group B: Control Group | Placebo comparator | Procedure: Virtual Reality TechnologyAbout 25 women indicated for diagnostic hysteroscopy without using Virtual Reality Technology |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled for diagnostic hysteroscopy e.g. Infertility, AUB
Key exclusion criteria (5 listed)
- Absolute contraindication to office hysteroscopy such as acute pelvic infection , active genital herpes , heavy bleeding or pregnancy.
- Psychological ,hearing or visual disorders.
- known anatomical condition that make performing office hysteroscopy is difficult such as cervical stenosis ,fibrosis or cervical amputation .
- Previous history of failed office hysteroscopy
- Patients scheduled for operative hysteroscopy.
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 TechnologyAlso: HysteroscopyTo evaluate the role of virtual reality technology as distraction technique in the management of acute pain during outpatient hysteroscopy | Procedure or surgery | Group A: Cases Group, Group B: Control Group |
Primary outcome
Assessment of Pain
Time frame: 10 minutes from starting the procedure
The pain level of the cases is evaluated by means of the digital pain as the 11-point visual analog scale (VAS) whereas 0-Represents no pain, 10 - Worst imaginable pain), as well as the 11-point VAS-A (0-Represents no anxiety, 10 - Highest anxiety)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Amr Elhussieny, Professor study chair
Head of Obstetrics and Gynecology department , Faculty of Medicine, Ain Shams University
Mortada El Sayed Ahmed, Professor study director
Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
Radwa Rsaheedy Ali, M.D principal investigator
Department of obstetrics & gynecology, Faculty Of Medicine, Ain Shams University
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 Technology in people with Acute Pain and Anxiety, run by Egymedicalpedia at 1 site in Egypt.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 May 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed Mohamed shawky, MSC (+201093699004, Waleed.shawky.94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain (time frame: 10 minutes from starting the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024.