Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change
NCT ID: NCT04472416
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-04-21
2023-09-19
Brief Summary
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Detailed Description
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The day of the procedure, each patient will receive a standardized local and systemic analgesia 30 minutes before starting the procedure. The referring surgeon will explain at this moment every step of the procedure of bedside abdominal VAC dressing change.
Baseline levels of pain and anxiety will be assessed by use of VAS (0-10) and one additional questionnaire (STAI).
Virtual reality device will be activated 15 minutes before the beginning of the procedure and will remain as long as the procedure is going on and for 15minutes after finishing the wound dressing.
15 minutes after removing the VRD and 30minutes after finishing the wound dressing the STAI questionnaire and VAS for anxiety, pain and satisfaction (0-10) will be completed by the patient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standardized analgesic protocol alone
Abdominal VAC dressing change using an standardized analgesic protocol alone.
No interventions assigned to this group
VRD + standardized analgesic protocol
Abdominal VAC dressing change using standardized analgesic protocol + virtual reality device
VRD in addition to standardized analgesic protocol
Use of VRD in addition to standardized analgesic protoco for abdominal VAC dressing change
Interventions
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VRD in addition to standardized analgesic protocol
Use of VRD in addition to standardized analgesic protoco for abdominal VAC dressing change
Eligibility Criteria
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Inclusion Criteria
* Patients above 18 years old
* Patients able to give informed consent as documented by signature
Exclusion Criteria
* Patients with impaired cognitive status
* Patients with known psychiatric disorders
* Patients unable to follow the procedures of the study due to language problems
* Not consent provided
* Prior inclusion in the same trial (only 1 VAC dressing change per patient can be studied, the first one)
* Pregnant patients
18 Years
ALL
No
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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Nicolas DEMARTINES
Prof.
Principal Investigators
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Martin Hubner, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Locations
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Department of Visceral Surgery, University Hospital Center
Lausanne, , Switzerland
Countries
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References
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Ma Z, Shou K, Li Z, Jian C, Qi B, Yu A. Negative pressure wound therapy promotes vessel destabilization and maturation at various stages of wound healing and thus influences wound prognosis. Exp Ther Med. 2016 Apr;11(4):1307-1317. doi: 10.3892/etm.2016.3083. Epub 2016 Feb 17.
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Sharar SR, Carrougher GJ, Nakamura D, Hoffman HG, Blough DK, Patterson DR. Factors influencing the efficacy of virtual reality distraction analgesia during postburn physical therapy: preliminary results from 3 ongoing studies. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S43-9. doi: 10.1016/j.apmr.2007.09.004.
Wiederhold MD, Gao K, Wiederhold BK. Clinical use of virtual reality distraction system to reduce anxiety and pain in dental procedures. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):359-65. doi: 10.1089/cyber.2014.0203.
Atzori B, Hoffman HG, Vagnoli L, Patterson DR, Alhalabi W, Messeri A, Lauro Grotto R. Virtual Reality Analgesia During Venipuncture in Pediatric Patients With Onco-Hematological Diseases. Front Psychol. 2018 Dec 20;9:2508. doi: 10.3389/fpsyg.2018.02508. eCollection 2018.
Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.
Riva G, Mantovani F, Capideville CS, Preziosa A, Morganti F, Villani D, Gaggioli A, Botella C, Alcaniz M. Affective interactions using virtual reality: the link between presence and emotions. Cyberpsychol Behav. 2007 Feb;10(1):45-56. doi: 10.1089/cpb.2006.9993.
Anderson AP, Mayer MD, Fellows AM, Cowan DR, Hegel MT, Buckey JC. Relaxation with Immersive Natural Scenes Presented Using Virtual Reality. Aerosp Med Hum Perform. 2017 Jun 1;88(6):520-526. doi: 10.3357/AMHP.4747.2017.
Navarro-Haro MV, Lopez-Del-Hoyo Y, Campos D, Linehan MM, Hoffman HG, Garcia-Palacios A, Modrego-Alarcon M, Borao L, Garcia-Campayo J. Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. PLoS One. 2017 Nov 22;12(11):e0187777. doi: 10.1371/journal.pone.0187777. eCollection 2017.
Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
Guo C, Deng H, Yang J. Effect of virtual reality distraction on pain among patients with hand injury undergoing dressing change. J Clin Nurs. 2015 Jan;24(1-2):115-20. doi: 10.1111/jocn.12626. Epub 2014 Jun 4.
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Ding J, He Y, Chen L, Zhu B, Cai Q, Chen K, Liu G. Virtual reality distraction decreases pain during daily dressing changes following haemorrhoid surgery. J Int Med Res. 2019 Sep;47(9):4380-4388. doi: 10.1177/0300060519857862. Epub 2019 Jul 25.
Umezawa S, Higurashi T, Uchiyama S, Sakai E, Ohkubo H, Endo H, Nonaka T, Nakajima A. Visual distraction alone for the improvement of colonoscopy-related pain and satisfaction. World J Gastroenterol. 2015 Apr 21;21(15):4707-14. doi: 10.3748/wjg.v21.i15.4707.
Other Identifiers
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2020-00091
Identifier Type: -
Identifier Source: org_study_id