Hemodialysis PatientsNCT05693584
The Effect of Using Virtual Reality Glasses on Pain During Fistula Cannulation in Hemodialysis Patients
A study testing distraction in people with Hemodialysis Patients, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
Hemodialysis; It is the process of returning the liquid and solute content of the blood taken from the patient to the patient as a result of rearrangement by means of a membrane and with the help of a machine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Nov 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Regular hemodialysis,
- A single injection from the AVF was attempted,
- Patients who do not have vision or hearing problems and who agree to participate in the study.
Who cannot join
- Have taken any analgesic in the last 3 hours,
- Redness in the fistula area, signs of infection,
- Does not speak Turkish, has language problems; illiterate patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Virtual Reality Glasses on Pain During Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Study
Hemodialysis; It is the process of returning the liquid and solute content of the blood taken from the patient to the patient as a result of rearrangement by means of a membrane and with the help of a machine. A permanent vascular access that can be used for months or years is required for HD treatment to be sufficient for patients with end-stage renal disease to survive and improve their quality of life. For this reason, patients who will be treated for HD need to have an arterio-venous fistula (AVF), graft or catheter to ensure adequate blood flow. CRF patients treated with HD are exposed to 300-320 AVF cannulations per year on average. The size and length of the diameter of the fistula needles, the piercing process created in the skin, the advancement of the needles into the tissue during the procedure, the entry angle of the needles and the entry techniques cause the patients to experience pain during the procedure.
Non-pharmacological methods frequently used in pain control include many applications such as distraction, massage, hot and cold application, aromatherapy.
Read more
Distraction, which is one of the non-pharmacological methods, is a method that enables patients to focus their attention on a different point and to control and reduce the symptoms they experience. Methods such as listening to music, taking pictures, watching television, solving puzzles, daydreaming, deep breathing and coughing exercises, sphygmomanometer blowing, active listening, tapping, inflating balloons, distraction cards and using virtual reality glasses are used for this purpose.
With the virtual reality glasses, the individual gets away from the environment with the glasses connected to the device worn on his head and the sounds coming from the headset, concentrates his attention on the image he watches and feels like he is in another world thanks to these five-dimensional glasses. The most basic feature that distinguishes virtual reality glasses from similar applications is that it gives people a real feeling. Virtual reality glasses, which are easy to apply and use, have no side effects, and can be effective in physical, psychological and social recovery, are an initiative that can be preferred in health applications.
In this study, it is aimed to determine the effect of using virtual reality glasses on pain during fistula cannulation applied to hemodialysis patients.
The hypotheses of the research; H₀: The use of virtual reality glasses is not effective in reducing the severity of pain.
H1: The use of virtual reality glasses reduces the severity of pain.
Read the detailed description
The research was carried out with patients in the hemodialysis unit of a private hospital in Istanbul, between September and November 2022.The study had a pre-test post-test design and was a single-center, parallel-design, randomized controlled experimental study.
Priori Power Analysis was performed to determine the sample size and Cohen's standard effect size reference method was chosen accordingly. Considering 85% power, 0.005 significance level, and 0.8 effect size for the study, the minimum required sample size was calculated as 23 for each group. Since it was thought that there might be data loss, it was decided to include 28 patients in each group and 56 patients in total.
Computer-assisted simple randomization (https://www.randomizer.org/) was used to determine the groups. There wasn't any blocking in this simple randomization. There wasn't any blinding for the patients or the researchers throughout the study. Pain assessments were made by the service nurses, and virtual reality glasses were applied by the researcher. The data were collected by one researcher and the analysis and evaluations were made by the other researcher. Thus, blanking was used during data collection and analysis.
The population of the study consists of patients (n=82) in the hemodialysis unit of a private hospital in Istanbul, and the sample consists of patients who meet the research criteria and agree to participate in the study (n=47).
In data collection; Introductory Information Form and Visual Analog Scale (Visual Comparison Scale) (VAS) were used.
Virtual reality glasses: Bobo VR Z4 brand virtual reality glasses with 5.7 inch 1440x2560 pixel screen resolution and JBL brand wireless headset were used.
In this study, it is planned to analyze the data in SPSS program. Normality tests, mean, standard deviation, minimum, maximum, number-percentage distributions in data analysis; Independent Groups t-test, Mann Whitney U test, One-Way Analysis of Variance, Kruskal-Wallis test will be used. Differences between groups in terms of categorical variables will be examined with the chi-square test. Pearson correlation analysis will be used to examine the relationships between variables, and Cohen-d effect size will be used to determine the effect size.
- Conditions
- Hemodialysis Patients
- Being tested
- distraction
- Keywords
- avf cannulation, hemodialysis, pain, virtual reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distractionOther
diverting the patient's attention with virtual reality glasses
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses | Experimental | Experimental group:Group applying virtual reality glasses Receives: Other: distraction |
| Routine practices | No intervention | No procedure was performed on the patients other than the routine practices of the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (Visual Comparison Scale) (VAS)
One end of the VAS is 10 cm or 100 mm, which indicates that the patient has very good, no pain (0 points), and the other end is very bad, unbearable pain (10/100 points). It is a scale that is evaluated by making
Measured: immediately after intervention
Secondary outcomes (1)
Visual Analog Scale (Visual Comparison Scale) (VAS)
One end of the VAS is 10 cm or 100 mm, which indicates that the patient has very good, no pain (0 points), and the other end is very bad, unbearable pain (10/100 points). It is a scale that is evaluated by making
Measured: 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Sep 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Elmali Simsek, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693584
- Sponsor's protocol ID
- fbu_nurs_elmali_001
- Status last verified
- Jan 2023
- First submitted
- 26 Dec 2022
- Last updated
- 23 Jan 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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Virtual Reality Glasses on Pain During Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05693584
- Acronym / sponsor ID
- fbu_nurs_elmali_001
- Conditions
- Hemodialysis Patients
- Keywords
- avf cannulation, hemodialysis, pain, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 23 Jan 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.
Hemodialysis; It is the process of returning the liquid and solute content of the blood taken from the patient to the patient as a result of rearrangement by means of a membrane and with the help of a machine. A permanent vascular access that can be used for months or years is required for HD treatment to be sufficient for patients with end-stage renal disease to survive and improve their quality of life. For this reason, patients who will be treated for HD need to have an arterio-venous fistula (AVF), graft or catheter to ensure adequate blood flow. CRF patients treated with HD are exposed to 300-320 AVF cannulations per year on average. The size and length of the diameter of the fistula needles, the piercing process created in the skin, the advancement of the needles into the tissue during the procedure, the entry angle of the needles and the entry techniques cause the patients to experience pain during the procedure.
Non-pharmacological methods frequently used in pain control include many applications such as distraction, massage, hot and cold application, aromatherapy.
Distraction, which is one of the non-pharmacological methods, is a method that enables patients to focus their attention on a different point and to control and reduce the symptoms they experience. Methods such as listening to music, taking pictures, watching television, solving puzzles, daydreaming, deep breathing and coughing exercises, sphygmomanometer blowing, active listening, tapping, inflating balloons, distraction cards and using virtual reality glasses are used for this purpose.
With the virtual reality glasses, the individual gets away from the environment with the glasses connected to the device worn on his head and the sounds coming from the headset, concentrates his attention on the image he watches and feels like he is in another world thanks to these five-dimensional glasses. The most basic feature that distinguishes virtual reality glasses from similar applications is that it gives people a real feeling. Virtual reality glasses, which are easy to apply and use, have no side effects, and can be effective in physical, psychological and social recovery, are an initiative that can be preferred in health applications.
In this study, it is aimed to determine the effect of using virtual reality glasses on pain during fistula cannulation applied to hemodialysis patients.
The hypotheses of the research; H₀: The use of virtual reality glasses is not effective in reducing the severity of pain.
H1: The use of virtual reality glasses reduces the severity of pain.
Detailed description
The research was carried out with patients in the hemodialysis unit of a private hospital in Istanbul, between September and November 2022.The study had a pre-test post-test design and was a single-center, parallel-design, randomized controlled experimental study.
Priori Power Analysis was performed to determine the sample size and Cohen's standard effect size reference method was chosen accordingly. Considering 85% power, 0.005 significance level, and 0.8 effect size for the study, the minimum required sample size was calculated as 23 for each group. Since it was thought that there might be data loss, it was decided to include 28 patients in each group and 56 patients in total.
Computer-assisted simple randomization (https://www.randomizer.org/) was used to determine the groups. There wasn't any blocking in this simple randomization. There wasn't any blinding for the patients or the researchers throughout the study. Pain assessments were made by the service nurses, and virtual reality glasses were applied by the researcher. The data were collected by one researcher and the analysis and evaluations were made by the other researcher. Thus, blanking was used during data collection and analysis.
The population of the study consists of patients (n=82) in the hemodialysis unit of a private hospital in Istanbul, and the sample consists of patients who meet the research criteria and agree to participate in the study (n=47).
In data collection; Introductory Information Form and Visual Analog Scale (Visual Comparison Scale) (VAS) were used.
Virtual reality glasses: Bobo VR Z4 brand virtual reality glasses with 5.7 inch 1440x2560 pixel screen resolution and JBL brand wireless headset were used.
In this study, it is planned to analyze the data in SPSS program. Normality tests, mean, standard deviation, minimum, maximum, number-percentage distributions in data analysis; Independent Groups t-test, Mann Whitney U test, One-Way Analysis of Variance, Kruskal-Wallis test will be used. Differences between groups in terms of categorical variables will be examined with the chi-square test. Pearson correlation analysis will be used to examine the relationships between variables, and Cohen-d effect size will be used to determine the effect size.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses | Experimental | Other: distractionExperimental group:Group applying virtual reality glasses |
| Routine practices | No intervention | –No procedure was performed on the patients other than the routine practices of the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old,
- Regular hemodialysis,
- A single injection from the AVF was attempted,
- Patients who do not have vision or hearing problems and who agree to participate in the study.
Key exclusion criteria (3 listed)
- Have taken any analgesic in the last 3 hours,
- Redness in the fistula area, signs of infection,
- Does not speak Turkish, has language problems; illiterate patients
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 |
|---|---|---|
| distractiondiverting the patient's attention with virtual reality glasses | Other | Virtual reality glasses |
Primary outcome
Visual Analog Scale (Visual Comparison Scale) (VAS)
Time frame: immediately after intervention
One end of the VAS is 10 cm or 100 mm, which indicates that the patient has very good, no pain (0 points), and the other end is very bad, unbearable pain (10/100 points). It is a scale that is evaluated by making
1 secondary outcome
Visual Analog Scale (Visual Comparison Scale) (VAS)
Time frame: 30 minutes after intervention
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 23 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distraction in people with Hemodialysis Patients, run by Fenerbahce University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 23 Jan 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 Turkey (Türkiye). 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?
Visual Analog Scale (Visual Comparison Scale) (VAS) (time frame: immediately after intervention). 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 23 Jan 2023.