Pregnancy TerminationVRPASABNCT06029582
VR Headset for Pain During Pregnancy Termination
A study testing VR headset in people with Pregnancy Termination, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
The goal of this randomized control study is to see if virtual reality headsets (VRHS) are useful in women undergoing surgical pregnancy termination. The main questions it aims to answer are: Do VRHS decrease the pain associated with surgical pregnancy termination Participants will wear the VRHS during the surgery and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Termination
- What is being tested?
- VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 7 Jul 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all healthy patients undergoing a first or second trimester pregnancy termination
Who cannot join
- pregnancy patients requesting a termination under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Allentown Women Center
Allentown, Pennsylvania, 18015
James N Anasti, MD, 610-844-2106, anastij@slhn.org
About this study
Official title: The Use of Virtual Reality Headset in Controlling Pain During Pregnancy Termination; a Randomized Control Trial
The goal of this randomized control study is to see if virtual reality headsets (VRHS) are useful in women undergoing surgical pregnancy termination. The main questions it aims to answer are:
Do VRHS decrease the pain associated with surgical pregnancy termination Participants will wear the VRHS during the surgery and take a pain survey before and after the procedure. The pain assessment will be compared to placebo headset which will be randomly assigned.
Read the detailed description
Use of virtual reality headsets have been employed in cancer and behavioral medicine fields with moderate success in controlling anxiety stress and pain. The decision to terminate a pregnancy can create significant stress and anxiety. In the US, there are over 900,000 pregnancy terminations each year with many patients undergoing dilation and evacuation with minimal anesthesia. We plan to assess virtual reality headset's ability to decrease pain associated with surgical termination of pregnancy.
Patient's will be recruited from a single outpatient family-planning center. Inclusion criteria include all patients over the age of 18 that are undergoing a surgical termination of pregnancy in the first and second trimester under local and/or conscious sedation anesthesia. Patients under the age of 18 with significant medical comorbidities will be excluded. Patient demographics including age, BMI, obstetric/ gynecology history, and prior terminations will be collected. Patients will be given pre- procedure survey to assess anxiety and stress. The survey will be self-administered with assistance from study personnel. Patients will then be randomized to either the virtual reality headset or no headset. The procedure will be then performed with the headsets on the patients. Amount and type of local anesthesia employed will be recorded. After the procedure (within 1 hour), the individuals will be resurveyed for both stress and anxiety, with the addition of a visual analog scale to assessing pain associated with the procedure. Pre and post vital signs will also be extracted from the chart. The patient as well as the clinician performing the procedure will be masked as to the intervention. We will require 50 patients per arm assuming a 30% reduction in the pain scale (power 80%, 95% CI, with SD of 0.70). Logistic regression will be performed for those comorbidities that may be influence our outcome, such as age, BMI, prior terminations.
- Conditions
- Pregnancy Termination
- Being tested
- VR headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR headsetDevice
Virtual Reality Headset
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality headset | Experimental | Individuals will wear the Virtual Reality Headset that produce a calming scenario Receives: Device: VR headset |
| controls | No intervention | no headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
A pain scale (visual analog scale) will be used to assess reduction of pain (scale 1-10) one being no pain, 10 highest level of pain
Measured: immediately after procedure (10 minutes)
Secondary outcomes (1)
Anxiety reduction
A scale will be used to assess anxiety (Visual analog scale: scale 1-10) 1 being no stress, 10 being highest level of stress
Measured: pre and post procedure 1 hr before procedure and within 10 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start20 Jun 2023
- Primary completion8 Jun 2024 (estimated)
- Study completion7 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy TerminationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James N Anasti, MD, Principal investigator, St Luke's University Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029582
- Sponsor's protocol ID
- SLIR-2023-55
- Acronym
- VRPASAB
- Status last verified
- Aug 2023
- First submitted
- 20 Jun 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality Headset in Controlling Pain During Pregnancy Termination; a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06029582
- Acronym / sponsor ID
- VRPASAB / SLIR-2023-55
- Conditions
- Pregnancy Termination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 8 Jun 2024 (estimated)
- Study completion
- 7 Jul 2024 (estimated)
- First posted
- 8 Sep 2023 (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 goal of this randomized control study is to see if virtual reality headsets (VRHS) are useful in women undergoing surgical pregnancy termination. The main questions it aims to answer are:
Do VRHS decrease the pain associated with surgical pregnancy termination Participants will wear the VRHS during the surgery and take a pain survey before and after the procedure. The pain assessment will be compared to placebo headset which will be randomly assigned.
Detailed description
Use of virtual reality headsets have been employed in cancer and behavioral medicine fields with moderate success in controlling anxiety stress and pain. The decision to terminate a pregnancy can create significant stress and anxiety. In the US, there are over 900,000 pregnancy terminations each year with many patients undergoing dilation and evacuation with minimal anesthesia. We plan to assess virtual reality headset's ability to decrease pain associated with surgical termination of pregnancy.
Patient's will be recruited from a single outpatient family-planning center. Inclusion criteria include all patients over the age of 18 that are undergoing a surgical termination of pregnancy in the first and second trimester under local and/or conscious sedation anesthesia. Patients under the age of 18 with significant medical comorbidities will be excluded. Patient demographics including age, BMI, obstetric/ gynecology history, and prior terminations will be collected. Patients will be given pre- procedure survey to assess anxiety and stress. The survey will be self-administered with assistance from study personnel. Patients will then be randomized to either the virtual reality headset or no headset. The procedure will be then performed with the headsets on the patients. Amount and type of local anesthesia employed will be recorded. After the procedure (within 1 hour), the individuals will be resurveyed for both stress and anxiety, with the addition of a visual analog scale to assessing pain associated with the procedure. Pre and post vital signs will also be extracted from the chart. The patient as well as the clinician performing the procedure will be masked as to the intervention. We will require 50 patients per arm assuming a 30% reduction in the pain scale (power 80%, 95% CI, with SD of 0.70). Logistic regression will be performed for those comorbidities that may be influence our outcome, such as age, BMI, prior terminations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality headset | Experimental | Device: VR headsetIndividuals will wear the Virtual Reality Headset that produce a calming scenario |
| controls | No intervention | –no headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all healthy patients undergoing a first or second trimester pregnancy termination
Key exclusion criteria (1 listed)
- pregnancy patients requesting a termination under the age of 18
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 |
|---|---|---|
| VR headsetVirtual Reality Headset | Device | Virtual Reality headset |
Primary outcome
Pain reduction
Time frame: immediately after procedure (10 minutes)
A pain scale (visual analog scale) will be used to assess reduction of pain (scale 1-10) one being no pain, 10 highest level of pain
1 secondary outcome
Anxiety reduction
Time frame: pre and post procedure 1 hr before procedure and within 10 minutes after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- 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.
James N Anasti, MD principal investigator
St Luke's University Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR headset in people with Pregnancy Termination, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
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 1 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 8 Sep 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James N Anasti, MD (484-526-8878, anastij@slhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: immediately after procedure (10 minutes)). 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 8 Sep 2023.