Clinical trial NCT06776497: The Effect of Video Streaming with Virtual Reality Glasses on Pain and Anxiety
Official title: The Effect of Vıdeo Streaming with Vırtual Realıty Glasses Durıng Arterıovenous Fıstula Needle Insertıonon on Paın and Anxıety of Indıvıduals Undergoıng Haemodıalysıs Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Keywords: Anxiety
Hemodialysis
Virtual reality glasses
Pain
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2025-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized, controlled experimental clinical trial to determine the effectiveness of a video played with virtual reality glasseson pain at the vascular access site and anxiety during an AVF catheter procedure in individuals who were undergoing haemodialysis treatment.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to examine the effect of a video played with VRG during arteriovenous fistula needle insertionon pain and anxiety of patients undergoing haemodialysis treatment. The sample of the study consisted of a total of 80 patients including 40 in the interventiongroup and 40 in control group who were treated in the haemodialysis ward. The data were collected using aPersonal Information Form prepared by the researcher upon review of the relevant literature to identify the patient's descriptive and medical characteristics, the Visual Analogue Scale (VAS) to assess the severity of pain, and the State-Trait Anxiety Inventory to determine the level of anxiety and VRH.

Detailed description: The data were collected using a Patient Information Form prepared by the researcher upon review of the relevant literature to identify the patient's descriptive and medical characteristics, the Visual Analogue Scale (VAS) to assess the severity of pain, and the State-Trait Anxiety Inventory to determine the level of anxiety and VRH. Additionally, the "Informed Voluntary Consent Form" was used to inform the participants about the study and obtain their consent Individuals who met the inclusion criteria and signed the informed consent form were assigned to the study groups based on a list which was numbered and generated in the computer environment before the AVF procedure. According to the results given by the computer programme, the individuals were assigned to the control group and the VRGgroup.While the control group included patients who

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 underwent AVF procedure with the standard method, the virtual reality glasses group included patients who underwent AVF procedure during the VRGapplication. Nurses working in the haemodialysisunit at the time of the study performed AVF procedures in accordance with the haemodialysis procedure protocol. The researcher filled in the descriptive data of the individuals using patient and file records.The individuals were informed about the VAS and the State-Trait Anxiety Inventory.

Eligibility criteria: Inclusion Criteria:

* Those aged 18 years and older,
* Those who were not pregnant and had no plans to become pregnant,
* Those who had been undergoing HD treatment in HD wards for at least three months and three sessions per week,
* Those who continued dialysis treatment at the same institution,
* Those for whom there were no changes in the treatment programme during the research period,
* Those who had no pain in any part of the body that would affect the study outcome and scored zero on the Visual Analogue Scale for pain at the time of admission,
* Those who had not taken analgesics in the last 24 hours,
* Those who could understand and communicate in Turkish,
* Those who volunteered to participate in the study and signed the written informed consent form were included in the study.

Exclusion Criteria:

* Those who declined to participate in the study,
* Those with a diagnosed neurological disease such as epilepsy, Alzheimer's disease, Parkinson's disease,and Multiple Sclerosis.
* Those with visual and hearing impairments,
* Those who took anxiolytic and/or sedative medications,
* Those who were clinically unstable,

Primary outcomes:
measure: The Visual Analogue Scale (VAS)
timeFrame: one week
measure: State-Trait Anxiety Inventory
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes Üniversty
state: Talas
Study officials:
References: