NCT05693584

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

December 26, 2022

Last Update Submit

January 11, 2023

Conditions

Keywords

avf cannulationhemodialysispainvirtual reality

Outcome Measures

Primary 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

    immediately after intervention

Secondary Outcomes (1)

  • Visual Analog Scale (Visual Comparison Scale) (VAS)

    30 minutes after intervention

Study Arms (2)

Virtual reality glasses

EXPERIMENTAL

Experimental group:Group applying virtual reality glasses

Other: distraction

Routine practices

NO INTERVENTION

No procedure was performed on the patients other than the routine practices of the clinic.

Interventions

diverting the patient's attention with virtual reality glasses

Virtual reality glasses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicana Çamlıca Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone LengtheningOrthopedic ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator (Dr)

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 23, 2023

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations