Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04687501
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2020-03-03
Brief Title:
Effect of VR on Anxiety and Pain in Gynecological Surgery
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
The Effect of Virtual Reality on Anxiety and Pain in Patients Undergoing Gynecological Surgery a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VRAP-G
Brief 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 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
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 users 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
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 users 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None