Pain, PostoperativeVRAP-GNCT04687501
Effect of VR on Anxiety and Pain in Gynecological Surgery
A study testing Virtual Reality in people with Pain, Postoperative and Anxiety, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Rationale: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence virtual reality (VR) is effective in the reduction of acute pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Anxiety, Pain Catastrophizing
- What is being tested?
- Virtual Reality
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Oct 2020to 9 Jul 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker
- Indication for elective gynecological surgery under spinal anesthesia
- No contra-indication to anesthesia:
Who cannot join
- Chronic pain patients; defined as 'persistent or recurrent pain lasting longer than 3 months' . The pain is not due to the gynecological problem.
- Chronical use of pain medication (opioids)
- History of prior opioid use defined as use within 8 to 90 days prior to the surgical procedure
- Alcohol or drug abuse
- Known car sickness
- Epileptic insults in previous history
Show all 10Show fewer
- Psychotically seizures in previous history
- Claustrophobic
- Blindness
- History of mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Anxiety and Pain in Patients Undergoing Gynecological Surgery; a Randomised Controlled Trial
Rationale: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence virtual reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects.
Objective: The aim of this study is to explore the effect of VR on pain in the immediate postoperative period after elective gynecological surgery.
Read more
Secondary objectives are evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use.
Study design: The study concerns a non-blinded, single centre, randomised controlled trial.
Study population: Eligible women fulfill the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Centre location Heerlen.
Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomised to the standard care- group will receive only the usual standard care pre-and postoperative.
Main study parameters: The primary outcome is postoperative pain measured on a numeric rating scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in the study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The study population experiences a small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults.
Participants of the study have to fill in a questionnaire before randomization and pre-and postoperative score of pain and anxiety on a zero to ten score scale.
Read the detailed description
"An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage", this is the definition of pain according to the International Association for the Study of Pain (IASP). Severe post-operative pain is experienced by approximately 50-80% of the patients.
Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. Postoperative pain can cause a higher morbidity, because of cardiovascular, pulmonic and gastro-intestinal problems.
Besides, surgery and acute pain are both independent risk factors for the development of chronic pain. The reduction of acute pain and therefore managing postoperative pain may contribute to the prevention of chronic pain.
In general, nowadays, medication is the treatment of choice for acute pain and mainly opioid analgesics are used for pain relief. Worldwide this contributes to excessive drug dependence and opioid abuse. Opioid use comes with several negative side effects, for example a potential delay in recovery and an increased risk of permanent disability.
Nowadays, new methods related to pain management are developed. For example, Virtual reality (VR) is an upcoming technology used within healthcare. It is thought that the perception of pain is related to the amount of attention that is given to pain stimuli. The theory behind the working mechanism of VR to reduce pain is that VR acts as a distraction to limit the user's processing of nociceptive stimuli, by stimulating the visual cortex in the brain. In 2000, Hoffman published the first preliminary evidence for the beneficial effect of VR in reducing pain in a burn care unit. They also showed a trend to experience less anxiety during VR use. In the next upcoming years, a growing body of research was done to explore the effects of VR.
A recent systematic review and meta-analysis showed VR to be an effective treatment for reducing acute pain. Next to being effective in reducing pain, it is also a proven useful tool in reducing preoperative anxiety. VR can be used as a safe, non-invasive, analgesic method, without risks of drug addiction and minimum side effects.
In this study, the investigators want to explore the effect of VR on postoperative pain in patients undergoing elective gynecological surgery as a serious alternative for pain medication. The investigators hypothesize VR will reduce post-operative pain and consequently postoperative opioid use and anxiety reduction.
- Conditions
- Pain, Postoperative, Anxiety, Pain Catastrophizing, State Anxiety
- Being tested
- Virtual Reality
- Keywords
- Postoperative pain, Anxiety, State anxiety, Pain catastrophizing, Analgesic use
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual reality in gynaecological surgery in the pre- and postoperative setting
| Study group | Role | What they receive |
|---|---|---|
| VR-group | Experimental | The participants randomised into this group can choose for an immersive guided relaxation VR experience or an interactive VR experience. The VR intervention is additional to the standard postoperative care management, the standard pain protocol is explained below.
The VR-intervention will be given using the Oculus Go Virtual Reality glasses with touchpad. Receives: Device: Virtual Reality |
| Standard care-group | No intervention | The participants randomized into the standard care- group will receive the usual standard pre-and postoperative management. Standard pain protocol: 1. Preoperative (arrival day-care unit) start with 1000mg paracetamol orally administered. 2. Postoperative Meloxicam 15mg orally administered, or when oral medication is not possible (due to nausea e.g.) than diclofenac supp 100mg or diclofenac i.v. 75mg. 3. On recovery ward, when necessary depending on pain score (NRS>4): dipidolor 2.5-5mg i.v. and 10-15mg i.m. after consulting the anesthesiologist. 4. Postoperative at home 4dd1000mg paracetamol will be continued, in combination with meloxicam 1dd15mg during 3 days. Also tramadol 50mg with a maximum of 4dd will be prescribed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain
reduction in postoperative pain score (NRS, numeric rating scale). Scaling from 0-10, where 0 means no pain and 10 means the worst imaginable pain
Measured: immediately after surgery
Secondary outcomes (7)
STAI (State-Trait Anxiety Inventory) questionnaire (6 questions)
Pre-operative anxiety. The score ranges from 20 to 90 and the higher the score the more anxiety the person experiences
Measured: baseline
Pain Catastrophizing Scale questionnaire
Pain catastrophizing. The subscales of the PCS can be calculated separately or overall with a maximum total score of 52. The higher the score, the more catastrophizing thoughts are present.
Measured: baseline
NRS anxiety
Difference in anxiety scores pre-and post VR intervention. Scaling on a scale form 0 to 10, where 0 means no anxiety and 10 means the worst imaginable anxiety
Measured: baseline and immediately after surgery
Analgesic use
daily use of paracetamol, NSAIDs, opioids
Measured: Within 24-48hours after surgery
Length of hospital stay
Length of hospital stay
Measured: within 24-48hours after surgery
VR Questionnaire
Tolerability, feasibility and satisfaction of VR use
Measured: within 24hours after surgery
NRS pain preoperative
Preoperative pain score (NRS). Scaling from 0-10, where 0 means no pain and 10 means the worst imaginable pain
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start22 Oct 2020
- Primary completion8 Jul 2022
- Study completion9 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilse Bekkers, Zuyderland Medisch Centrum
- Investigators
- Martine Wassen, Dr, Principal investigator, Zuyderland Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687501
- Sponsor's protocol ID
- NL72290.096.20
- Acronym
- VRAP-G
- Status last verified
- Aug 2022
- First submitted
- 3 Mar 2020
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Treede RD. The International Association for the Study of Pain definition of pain: as valid in 2018 as in 1979, but in need of regularly updated footnotes. Pain Rep. 2018 Mar 5;3(2):e643. doi: 10.1097/PR9.0000000000000643. eCollection 2018 Mar.
PubMed 29756089Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.
PubMed 18945716Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
PubMed 29026331Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
PubMed 15763409Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth. 2019 Aug;123(2):e273-e283. doi: 10.1016/j.bja.2019.03.023. Epub 2019 May 10.
PubMed 31079836Zhao S, Chen F, Feng A, Han W, Zhang Y. Risk Factors and Prevention Strategies for Postoperative Opioid Abuse. Pain Res Manag. 2019 Jul 10;2019:7490801. doi: 10.1155/2019/7490801. eCollection 2019.
PubMed 31360271Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
PubMed 31308733Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.
PubMed 31412029Hoffman HG, Patterson DR, Carrougher GJ. Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. Clin J Pain. 2000 Sep;16(3):244-50. doi: 10.1097/00002508-200009000-00010.
PubMed 11014398Dehghan F, Jalali R, Bashiri H. The effect of virtual reality technology on preoperative anxiety in children: a Solomon four-group randomized clinical trial. Perioper Med (Lond). 2019 Jun 4;8:5. doi: 10.1186/s13741-019-0116-0. eCollection 2019.
PubMed 31171963JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi A, Mazluom SR, Golmakani N, Talebi M, Pabarja F. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial. Iran J Med Sci. 2015 May;40(3):219-24.
PubMed 25999621Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
PubMed 21779307Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
PubMed 25844555Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
PubMed 1393159Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
PubMed 28356241
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Anxiety and Pain in Patients Undergoing Gynecological Surgery; a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04687501
- Acronym / sponsor ID
- VRAP-G / NL72290.096.20
- Conditions
- Pain, Postoperative, Anxiety, Pain Catastrophizing, State Anxiety
- Keywords
- Postoperative pain, Anxiety, State anxiety, Pain catastrophizing, Analgesic use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 9 Jul 2022 (actual)
- First posted
- 29 Dec 2020 (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.
Rationale: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence virtual reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects.
Objective: The aim of this study is to explore the effect of VR on pain in the immediate postoperative period after elective gynecological surgery.
Secondary objectives are evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use.
Study design: The study concerns a non-blinded, single centre, randomised controlled trial.
Study population: Eligible women fulfill the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Centre location Heerlen.
Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomised to the standard care- group will receive only the usual standard care pre-and postoperative.
Main study parameters: The primary outcome is postoperative pain measured on a numeric rating scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in the study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The study population experiences a small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults.
Participants of the study have to fill in a questionnaire before randomization and pre-and postoperative score of pain and anxiety on a zero to ten score scale.
Detailed description
"An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage", this is the definition of pain according to the International Association for the Study of Pain (IASP). Severe post-operative pain is experienced by approximately 50-80% of the patients.
Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. Postoperative pain can cause a higher morbidity, because of cardiovascular, pulmonic and gastro-intestinal problems.
Besides, surgery and acute pain are both independent risk factors for the development of chronic pain. The reduction of acute pain and therefore managing postoperative pain may contribute to the prevention of chronic pain.
In general, nowadays, medication is the treatment of choice for acute pain and mainly opioid analgesics are used for pain relief. Worldwide this contributes to excessive drug dependence and opioid abuse. Opioid use comes with several negative side effects, for example a potential delay in recovery and an increased risk of permanent disability.
Nowadays, new methods related to pain management are developed. For example, Virtual reality (VR) is an upcoming technology used within healthcare. It is thought that the perception of pain is related to the amount of attention that is given to pain stimuli. The theory behind the working mechanism of VR to reduce pain is that VR acts as a distraction to limit the user's processing of nociceptive stimuli, by stimulating the visual cortex in the brain. In 2000, Hoffman published the first preliminary evidence for the beneficial effect of VR in reducing pain in a burn care unit. They also showed a trend to experience less anxiety during VR use. In the next upcoming years, a growing body of research was done to explore the effects of VR.
A recent systematic review and meta-analysis showed VR to be an effective treatment for reducing acute pain. Next to being effective in reducing pain, it is also a proven useful tool in reducing preoperative anxiety. VR can be used as a safe, non-invasive, analgesic method, without risks of drug addiction and minimum side effects.
In this study, the investigators want to explore the effect of VR on postoperative pain in patients undergoing elective gynecological surgery as a serious alternative for pain medication. The investigators hypothesize VR will reduce post-operative pain and consequently postoperative opioid use and anxiety reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-group | Experimental | Device: Virtual RealityThe participants randomised into this group can choose for an immersive guided relaxation VR experience or an interactive VR experience. The VR intervention is additional to the standard postoperative care management, the standard pain protocol is explained below. The VR-intervention will be given using the Oculus Go Virtual Reality glasses with touchpad. |
| Standard care-group | No intervention | –The participants randomized into the standard care- group will receive the usual standard pre-and postoperative management. Standard pain protocol: 1. Preoperative (arrival day-care unit) start with 1000mg paracetamol orally administered. 2. Postoperative Meloxicam 15mg orally administered, or when oral medication is not possible (due to nausea e.g.) than diclofenac supp 100mg or diclofenac i.v. 75mg. 3. On recovery ward, when necessary depending on pain score (NRS>4): dipidolor 2.5-5mg i.v. and 10-15mg i.m. after consulting the anesthesiologist. 4. Postoperative at home 4dd1000mg paracetamol will be continued, in combination with meloxicam 1dd15mg during 3 days. Also tramadol 50mg with a maximum of 4dd will be prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker
- Indication for elective gynecological surgery under spinal anesthesia
- No contra-indication to anesthesia:
Key exclusion criteria (10 listed)
- Chronic pain patients; defined as 'persistent or recurrent pain lasting longer than 3 months' . The pain is not due to the gynecological problem.
- Chronical use of pain medication (opioids)
- History of prior opioid use defined as use within 8 to 90 days prior to the surgical procedure
- Alcohol or drug abuse
- Known car sickness
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 RealityVirtual reality in gynaecological surgery in the pre- and postoperative setting | Device | VR-group |
Primary outcome
NRS pain
Time frame: immediately after surgery
reduction in postoperative pain score (NRS, numeric rating scale). Scaling from 0-10, where 0 means no pain and 10 means the worst imaginable pain
7 secondary outcomes
STAI (State-Trait Anxiety Inventory) questionnaire (6 questions)
Time frame: baseline
Pain Catastrophizing Scale questionnaire
Time frame: baseline
NRS anxiety
Time frame: baseline and immediately after surgery
Analgesic use
Time frame: Within 24-48hours after surgery
Length of hospital stay
Time frame: within 24-48hours after surgery
VR Questionnaire
Time frame: within 24hours after surgery
NRS pain preoperative
Time frame: baseline
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 16 Aug 2022.
- Background: PubMed 29756089Treede RD. The International Association for the Study of Pain definition of pain: as valid in 2018 as in 1979, but in need of regularly updated footnotes. Pain Rep. 2018 Mar 5;3(2):e643. doi: 10.1097/PR9.0000000000000643. eCollection 2018 Mar.
- Background: PubMed 18945716Popping DM, Zahn PK, Van Aken HK, Dasch B, Boche R, Pogatzki-Zahn EM. Effectiveness and safety of postoperative pain management: a survey of 18 925 consecutive patients between 1998 and 2006 (2nd revision): a database analysis of prospectively raised data. Br J Anaesth. 2008 Dec;101(6):832-40. doi: 10.1093/bja/aen300. Epub 2008 Oct 22.
- Background: PubMed 29026331Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Background: PubMed 15763409Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
- Background: PubMed 31079836Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth. 2019 Aug;123(2):e273-e283. doi: 10.1016/j.bja.2019.03.023. Epub 2019 May 10.
- Background: PubMed 31360271Zhao S, Chen F, Feng A, Han W, Zhang Y. Risk Factors and Prevention Strategies for Postoperative Opioid Abuse. Pain Res Manag. 2019 Jul 10;2019:7490801. doi: 10.1155/2019/7490801. eCollection 2019.
- Background: PubMed 31308733Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
- Background: PubMed 31412029Spiegel B, Fuller G, Lopez M, Dupuy T, Noah B, Howard A, Albert M, Tashjian V, Lam R, Ahn J, Dailey F, Rosen BT, Vrahas M, Little M, Garlich J, Dzubur E, IsHak W, Danovitch I. Virtual reality for management of pain in hospitalized patients: A randomized comparative effectiveness trial. PLoS One. 2019 Aug 14;14(8):e0219115. doi: 10.1371/journal.pone.0219115. eCollection 2019.
- Background: PubMed 11014398Hoffman HG, Patterson DR, Carrougher GJ. Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. Clin J Pain. 2000 Sep;16(3):244-50. doi: 10.1097/00002508-200009000-00010.
- Background: PubMed 31171963Dehghan F, Jalali R, Bashiri H. The effect of virtual reality technology on preoperative anxiety in children: a Solomon four-group randomized clinical trial. Perioper Med (Lond). 2019 Jun 4;8:5. doi: 10.1186/s13741-019-0116-0. eCollection 2019.
- Background: PubMed 25999621JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi A, Mazluom SR, Golmakani N, Talebi M, Pabarja F. The Effect of Virtual Reality on Pain in Primiparity Women during Episiotomy Repair: A Randomize Clinical Trial. Iran J Med Sci. 2015 May;40(3):219-24.
- Background: PubMed 21779307Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
- 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.
Martine Wassen, Dr principal investigator
Zuyderland Medical Centre
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 Zuyderland Medisch Centrum at 1 site in Netherlands.
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 5 inclusion and 10 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 16 Aug 2022. 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 Netherlands. 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?
NRS pain (time frame: immediately after surgery). 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 NCT04687501, which also lists 19 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 16 Aug 2022.