Surgical WoundNCT06476314
Virtual Reality Glasses and Stress Ball Applications in Dressing Change
A study testing Virtual Reality Glasses Group and Stress Ball Group in people with Surgical Wound and Abdominal Surgery, run by Suleyman Demirel University.
Trial summary
According to the statistical data of the Ministry of Health for the year 2021 in Türkiye, approximately 4.7 million surgical interventions are performed annually. According to the 2017 data from the National Health Service-Associated Infections Surveillance Network, the Surgical Site Infection (SSI) rate in our… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Abdominal Surgery
- What is being tested?
- Virtual Reality Glasses Group and Stress Ball Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jan 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acceptance to participate in the study both in writing and verbally.
- Being over 18,
- Having undergone abdominal surgery,
- Being on the 1st day after surgery,
- Being subjected to first dressing after surgery,
- Staying in the one-person room or being the only patient in the room,
- Being conscious (person, place and time orientation),
- Patients who have no vision, hearing or communication problems will be included in the study.
Who cannot join
- Patients using analgesic, anxiolytic, and sedative medications before, during, and immediately after dressing changes.
- Having chronic pain disorder
- Having a disease that may affect primarily vital signs (such as Hypertension, COPD),
- Not having any psychiatric and cognitive/mental disease (dementia, etc.),
- Having chronic diseases like epilepsy, vertigo,
- Being diagnosed with vision, hearing(auditory) and/or balance disorder
- Having an addiction or abusing alcohol or drugs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Examination of the Effects of Virtual Reality Glasses and Stress Ball Applications on Pain, Vital Signs Anxiety, Fear, Satisfaction, and Comfort Levels During the Dressing Changes in Patients Who Underwent Abdominal Surgery
According to the statistical data of the Ministry of Health for the year 2021 in Türkiye, approximately 4.7 million surgical interventions are performed annually. According to the 2017 data from the National Health Service-Associated Infections Surveillance Network, the Surgical Site Infection (SSI) rate in our country is 0.72%, and it is stated that it can be prevented by approximately 60%. Dressing application holds an important place in surgical wound management, wound healing, and preventing complications. Patients may experience pain, anxiety, and fear due to unknown factors and previous experiences during the dressing change which holds an important place in wound care management. The aim is to minimize patients\' negative emotions/situations during dressing changes by diverting their attention elsewhere using virtual reality (VR) glasses and stress balls. Upon reviewing the literature, no study was found that examines the effect of applying VR glasses and stress balls during abdominal surgery dressing changes on pain, vital signs, anxiety, fear, comfort, and satisfaction levels in adults. In this regard, the aim of the research is; to examine the effects of VR glasses and stress ball application on pain, vital signs, anxiety, fear, comfort, and satisfaction levels during dressing changes in patients undergoing abdominal surgery. The study was designed as a pre-test post-test control group randomized experimental model. The sample of the study consists of adult patients who underwent abdominal surgery in Isparta City Hospital General Surgery Service-1. In the study sample, 120 individuals were included in total 40 with VR glasses, 40 individuals using stress balls, and 40 in the control group. Patient Information Form, Visual Analog Scale, and State-Trait Anxiety Scale will be used in data collection. Data from the study will be analyzed with number, percent, average, x-square, variance, and t-test in a computer environment. In consideration of the data, it is believed that important findings will be obtained in increasing satisfaction and comfort by eliminating pain, anxiety, and fear during dressing changes in patients.
- Conditions
- Surgical Wound, Abdominal Surgery
- Being tested
- Virtual Reality Glasses Group, Stress Ball Group
- Keywords
- Dressing, surgical wound, incision, virtual reality glasses, stress ball, nursing care, pain, vital signs, anxiety, fear, satisfaction, comfort levels
- Medical subject headings
- Surgical Wound, Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Glasses GroupDevice
Apart from the routine clinic procedure, VR video scenes (contain nature views) will be watched for 5-10 minutes during the procedure.
Stress Ball GroupDevice
Apart from the routine clinic procedure, it will be asked squeezing the stress ball for about 5-10 minutes (squeezing it once every time he counts to five)during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | Apart from the routine clinic procedure, VR video scenes (contain nature views) will be watched for 5-10 minutes during the procedure. Receives: Device: Virtual Reality Glasses Group |
| Stress Ball Group | Experimental | Apart from the routine clinic procedure, it will be asked squeezing the stress ball for about 5-10 minutes (squeezing it once every time he counts to five)during the procedure. Receives: Device: Stress Ball Group |
| Control Group | No intervention | Only dressing will be changed just as routine clinic procedure without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
This form created by researchers, consists of a total of 14 questions. These questions include patients' age, gender, education level, marital status, employment status, income level, chronic disease status, history of previous surgeries, reason for hospital admission, knowledge about colonoscopy, preference for the current method if another colonoscopy is required, and inquiry about the use of additional sedation and painkillers during the procedure.
Measured: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
Visual Analog Scale (Visual Analog Skala-VAS)
The scale is a valid tool for measuring psychological and health variables such as pain and satisfaction, which are commonly used in clinical studies. It is a scale where the distance between two ends, with a minimum value of 0 at one end and a maximum value of 10 at the other end, is measured with a 10 cm ruler. (Price, 1983). The scale will be used to determine the pain, fear, satisfaction, and comfort levels of patients who underwent abdominal surgery during dressing changes. In this regard: It is explained to the patient that there are two extreme points and he is free to mark any place between these points that is convenient for him. The interval between the beginning of "No pain, fear, satisfaction, and comfort" and the point marked by the patient is measured and recorded in centimeters.
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
State Anxiety Inventory (In State-Trait Anxiety Inventory)
The scale is a valid and reliable scale adapted to Turkish. State anxiety inventory consists of two different scales including 40 items that individuals may use to express their emotions. The first twenty of these items, the state anxiety inventory determines persons' worry tendency due to individual characteristics. Statements in the scale are presented in the form of direct and inverted expressions. The scale was scored by giving four options for each statement. Spielberger and his colleagues state that scores ranging from 0 to 19 indicate no anxiety, 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and scores of 60-79 indicate severe anxiety, also individuals with a score of 60 and above require professional help. This scale will be used to determine the state anxiety status of patients who underwent abdominal surgery in this study.
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure.
Trait Anxiety Inventory (In State-Trait Anxiety Inventory)
The scale is a valid and reliable scale adapted to Turkish. State-trait anxiety inventory consists of two different scales including 40 items that individuals may use to express their emotions. The items from 21 to 40 on the scale, trait anxiety inventory, were prepared to determine anxiety felt by the individual due to stressful situations. Similarly, each statement has been scored with four options.Points obtained from both scales range between 20 and 80. Spielberger and his colleagues state that scores ranging from 0 to 19 indicate no anxiety, 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and scores of 60-79 indicate severe anxiety, also individuals with a score of 60 and above require professional help. This scale will be used to determine the trait anxiety status of patients who underwent abdominal surgery in this study.
Measured: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
Vital signs-pulse
Patients' pulse levels
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-systolic blood pressure
Patients' systolic blood pressure levels
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-diastolic blood pressure
Patients' diastolic blood pressure levels
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-fever
Patients' fever levels
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-respiratory rate
Patients' respiratory rate levels
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Vital signs-oxygen saturation
Patients' oxygen saturation levels
Measured: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Surgical WoundStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment experimental model using randomized pretest and posttest with control group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Altun Baksi, Suleyman Demirel University
- Investigators
- Altun Baksi, PhD, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476314
- Sponsor's protocol ID
- 22/326
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD that underlie results in a publication
Publications
Birnie KA, Kulandaivelu Y, Jibb L, Hroch P, Positano K, Robertson S, Campbell F, Abla O, Stinson J. Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer [Formula: see text]. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):406-416. doi: 10.1177/1043454218782138. Epub 2018 Jun 27.
PubMed 29950139Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.
PubMed 35068011Ding 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.
PubMed 31342823Dings SJM, van Stralen KJ, Struben VMD, Noordzij MA. Pain and anxiety during vasectomies while distracting patients with video glasses or virtual reality glasses. BJU Int. 2021 Nov;128(5):561-567. doi: 10.1111/bju.15332. Epub 2021 Jan 27.
PubMed 33387391Freitas DMO, Spadoni VS. Is virtual reality useful for pain management in patients who undergo medical procedures? Einstein (Sao Paulo). 2019 May 20;17(2):eMD4837. doi: 10.31744/einstein_journal/2019MD4837.
PubMed 31116237Furness PJ, Phelan I, Babiker NT, Fehily O, Lindley SA, Thompson AR. Reducing Pain During Wound Dressings in Burn Care Using Virtual Reality: A Study of Perceived Impact and Usability With Patients and Nurses. J Burn Care Res. 2019 Oct 16;40(6):878-885. doi: 10.1093/jbcr/irz106.
PubMed 31190052Gardner SE, Bae J, Ahmed BH, Abbott LI, Wolf JS, Hein M, Carter C, Hillis SL, Tandy LM, Rakel BA. A clinical tool to predict severe pain during wound dressing changes. Pain. 2022 Sep 1;163(9):1716-1727. doi: 10.1097/j.pain.0000000000002553. Epub 2021 Dec 15.
PubMed 35984382Guo 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.
PubMed 24899241Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.
PubMed 25641687Kim JY, Kim NK, Lee YJ. A descriptive study of Korean nurses' perception of pain and skin tearing at dressing change. Int Wound J. 2016 Mar;13 Suppl 1(Suppl 1):47-51. doi: 10.1111/iwj.12539.
PubMed 26847938Ricardo JW, Lipner SR. Utilizing a Sleep Mask to Reduce Patient Anxiety During Nail Surgery. Cutis. 2021 Jul;108(1):36. doi: 10.12788/cutis.0285.
PubMed 34397356
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effects of Virtual Reality Glasses and Stress Ball Applications on Pain, Vital Signs Anxiety, Fear, Satisfaction, and Comfort Levels During the Dressing Changes in Patients Who Underwent Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06476314
- Acronym / sponsor ID
- 22/326
- Conditions
- Surgical Wound, Abdominal Surgery
- Keywords
- Dressing, surgical wound, incision, virtual reality glasses, stress ball, nursing care, pain, vital signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 Jun 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.
According to the statistical data of the Ministry of Health for the year 2021 in Türkiye, approximately 4.7 million surgical interventions are performed annually. According to the 2017 data from the National Health Service-Associated Infections Surveillance Network, the Surgical Site Infection (SSI) rate in our country is 0.72%, and it is stated that it can be prevented by approximately 60%. Dressing application holds an important place in surgical wound management, wound healing, and preventing complications. Patients may experience pain, anxiety, and fear due to unknown factors and previous experiences during the dressing change which holds an important place in wound care management. The aim is to minimize patients\' negative emotions/situations during dressing changes by diverting their attention elsewhere using virtual reality (VR) glasses and stress balls. Upon reviewing the literature, no study was found that examines the effect of applying VR glasses and stress balls during abdominal surgery dressing changes on pain, vital signs, anxiety, fear, comfort, and satisfaction levels in adults. In this regard, the aim of the research is; to examine the effects of VR glasses and stress ball application on pain, vital signs, anxiety, fear, comfort, and satisfaction levels during dressing changes in patients undergoing abdominal surgery. The study was designed as a pre-test post-test control group randomized experimental model. The sample of the study consists of adult patients who underwent abdominal surgery in Isparta City Hospital General Surgery Service-1. In the study sample, 120 individuals were included in total 40 with VR glasses, 40 individuals using stress balls, and 40 in the control group. Patient Information Form, Visual Analog Scale, and State-Trait Anxiety Scale will be used in data collection. Data from the study will be analyzed with number, percent, average, x-square, variance, and t-test in a computer environment. In consideration of the data, it is believed that important findings will be obtained in increasing satisfaction and comfort by eliminating pain, anxiety, and fear during dressing changes in patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel assignment experimental model using randomized pretest and posttest with control group
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | Device: Virtual Reality Glasses GroupApart from the routine clinic procedure, VR video scenes (contain nature views) will be watched for 5-10 minutes during the procedure. |
| Stress Ball Group | Experimental | Device: Stress Ball GroupApart from the routine clinic procedure, it will be asked squeezing the stress ball for about 5-10 minutes (squeezing it once every time he counts to five)during the procedure. |
| Control Group | No intervention | –Only dressing will be changed just as routine clinic procedure without any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acceptance to participate in the study both in writing and verbally.
- Being over 18,
- Having undergone abdominal surgery,
- Being on the 1st day after surgery,
- Being subjected to first dressing after surgery,
Key exclusion criteria (7 listed)
- Patients using analgesic, anxiolytic, and sedative medications before, during, and immediately after dressing changes.
- Having chronic pain disorder
- Having a disease that may affect primarily vital signs (such as Hypertension, COPD),
- Not having any psychiatric and cognitive/mental disease (dementia, etc.),
- Having chronic diseases like epilepsy, vertigo,
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 Glasses GroupApart from the routine clinic procedure, VR video scenes (contain nature views) will be watched for 5-10 minutes during the procedure. | Device | Virtual Reality Glasses Group |
| Stress Ball GroupApart from the routine clinic procedure, it will be asked squeezing the stress ball for about 5-10 minutes (squeezing it once every time he counts to five)during the procedure. | Device | Stress Ball Group |
Primary outcome
Patient Information Form
Time frame: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
This form created by researchers, consists of a total of 14 questions. These questions include patients' age, gender, education level, marital status, employment status, income level, chronic disease status, history of previous surgeries, reason for hospital admission, knowledge about colonoscopy, preference for the current method if another colonoscopy is required, and inquiry about the use of additional sedation and painkillers during the procedure.
Visual Analog Scale (Visual Analog Skala-VAS)
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
The scale is a valid tool for measuring psychological and health variables such as pain and satisfaction, which are commonly used in clinical studies. It is a scale where the distance between two ends, with a minimum value of 0 at one end and a maximum value of 10 at the other end, is measured with a 10 cm ruler. (Price, 1983). The scale will be used to determine the pain, fear, satisfaction, and comfort levels of patients who underwent abdominal surgery during dressing changes. In this regard: It is explained to the patient that there are two extreme points and he is free to mark any place between these points that is convenient for him. The interval between the beginning of "No pain, fear, satisfaction, and comfort" and the point marked by the patient is measured and recorded in centimeters.
State Anxiety Inventory (In State-Trait Anxiety Inventory)
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure.
The scale is a valid and reliable scale adapted to Turkish. State anxiety inventory consists of two different scales including 40 items that individuals may use to express their emotions. The first twenty of these items, the state anxiety inventory determines persons' worry tendency due to individual characteristics. Statements in the scale are presented in the form of direct and inverted expressions. The scale was scored by giving four options for each statement. Spielberger and his colleagues state that scores ranging from 0 to 19 indicate no anxiety, 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and scores of 60-79 indicate severe anxiety, also individuals with a score of 60 and above require professional help. This scale will be used to determine the state anxiety status of patients who underwent abdominal surgery in this study.
Trait Anxiety Inventory (In State-Trait Anxiety Inventory)
Time frame: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.
The scale is a valid and reliable scale adapted to Turkish. State-trait anxiety inventory consists of two different scales including 40 items that individuals may use to express their emotions. The items from 21 to 40 on the scale, trait anxiety inventory, were prepared to determine anxiety felt by the individual due to stressful situations. Similarly, each statement has been scored with four options.Points obtained from both scales range between 20 and 80. Spielberger and his colleagues state that scores ranging from 0 to 19 indicate no anxiety, 20 to 39 indicate mild anxiety, 40 to 59 indicate moderate anxiety, and scores of 60-79 indicate severe anxiety, also individuals with a score of 60 and above require professional help. This scale will be used to determine the trait anxiety status of patients who underwent abdominal surgery in this study.
Vital signs-pulse
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' pulse levels
Vital signs-systolic blood pressure
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' systolic blood pressure levels
Vital signs-diastolic blood pressure
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' diastolic blood pressure levels
Vital signs-fever
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' fever levels
Vital signs-respiratory rate
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' respiratory rate levels
Vital signs-oxygen saturation
Time frame: Pre-test and post-test data will be collected from all three groups 10-15 minutes before the procedure
Patients' oxygen saturation levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 29950139Birnie KA, Kulandaivelu Y, Jibb L, Hroch P, Positano K, Robertson S, Campbell F, Abla O, Stinson J. Usability Testing of an Interactive Virtual Reality Distraction Intervention to Reduce Procedural Pain in Children and Adolescents With Cancer [Formula: see text]. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):406-416. doi: 10.1177/1043454218782138. Epub 2018 Jun 27.
- Background: PubMed 35068011Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.
- Background: PubMed 31342823Ding 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.
- Background: PubMed 33387391Dings SJM, van Stralen KJ, Struben VMD, Noordzij MA. Pain and anxiety during vasectomies while distracting patients with video glasses or virtual reality glasses. BJU Int. 2021 Nov;128(5):561-567. doi: 10.1111/bju.15332. Epub 2021 Jan 27.
- Background: PubMed 31116237Freitas DMO, Spadoni VS. Is virtual reality useful for pain management in patients who undergo medical procedures? Einstein (Sao Paulo). 2019 May 20;17(2):eMD4837. doi: 10.31744/einstein_journal/2019MD4837.
- Background: PubMed 31190052Furness PJ, Phelan I, Babiker NT, Fehily O, Lindley SA, Thompson AR. Reducing Pain During Wound Dressings in Burn Care Using Virtual Reality: A Study of Perceived Impact and Usability With Patients and Nurses. J Burn Care Res. 2019 Oct 16;40(6):878-885. doi: 10.1093/jbcr/irz106.
- Background: PubMed 35984382Gardner SE, Bae J, Ahmed BH, Abbott LI, Wolf JS, Hein M, Carter C, Hillis SL, Tandy LM, Rakel BA. A clinical tool to predict severe pain during wound dressing changes. Pain. 2022 Sep 1;163(9):1716-1727. doi: 10.1097/j.pain.0000000000002553. Epub 2021 Dec 15.
- Background: PubMed 24899241Guo 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.
- Background: PubMed 25641687Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.
- Background: PubMed 26847938Kim JY, Kim NK, Lee YJ. A descriptive study of Korean nurses' perception of pain and skin tearing at dressing change. Int Wound J. 2016 Mar;13 Suppl 1(Suppl 1):47-51. doi: 10.1111/iwj.12539.
- Background: PubMed 34397356Ricardo JW, Lipner SR. Utilizing a Sleep Mask to Reduce Patient Anxiety During Nail Surgery. Cutis. 2021 Jul;108(1):36. doi: 10.12788/cutis.0285.
- Individual participant dataSharing planned: No. All IPD that underlie results in a publication
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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.
Altun Baksi, PhD principal investigator
Suleyman Demirel University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses Group and Stress Ball Group in people with Surgical Wound and Abdominal Surgery, run by Suleyman Demirel University.
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 8 inclusion and 7 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Altun Baksi, PhD (+90 505 397 32 46, altunbaksi@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: Pre-test data will be collected from all three groups 10-15 minutes before the procedure.). The study lists 10 primary outcomes in all. 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 NCT06476314, which also lists 11 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 26 Jun 2024.