The Effect of Video Streaming with Virtual Reality Glasses on Pain and Anxiety

NCT ID: NCT06776497

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-08-30

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.

Conditions

Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention

The AVF catheter was inserted into the patients in the virtual reality group just before the clinic's standard haemodialysis procedure (5 minutes earlier), and the video continued to be played until the end of ten minutes after they were connected to the haemodialysis machine. Five minutes after the individual began watching the video, a routine AVF procedure was performed while the individual was still watching the video. During the haemodialysis, the patients in the VRGgroup were allowed to watch videos that they wanted to watch, such as walking in parks, nature and seaside hikes, underwater, museum tours, and feature films with VRGfor 10 minutes. After the time was up, the virtual reality application was terminated, and the VAS and the State-Trait Anxiety Inventory were filled out.

Group Type: EXPERIMENTAL

VIRTUAL REALITY GLASSES (VRG)

Intervention Type: DEVICE

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 arteriovenous fistula (AVF) procedure. According to the results given by the computer programme, the individuals were assigned to the control group and the virtual realitiy group (VRG)group. While the control group included patients who underwent AVF procedure with the standard method, the virtual reality headset group included patients who underwent AVF procedure during the VRG application.

control

The control group was subjected to AVF catheter insertion for the standard haemodialysis procedure of the clinic. According to this standard practice, the patients were not subjected to any procedure before AVF access. After they were connected to the haemodialysis machine, the VAS and the StateTrait Anxiety Inventory were completed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

VIRTUAL REALITY GLASSES (VRG)

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 arteriovenous fistula (AVF) procedure. According to the results given by the computer programme, the individuals were assigned to the control group and the virtual realitiy group (VRG)group. While the control group included patients who underwent AVF procedure with the standard method, the virtual reality headset group included patients who underwent AVF procedure during the VRG application.

Intervention Type: DEVICE

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: collaborator

Selcuk Ozturk

OTHER

Sponsor Role: lead

Responsible Party

Selcuk Ozturk

Student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Erciyes Üniversty

Kayseri, Talas, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Guler S, Ozturk S, Sahan S, Topaloglu US. The Effect of Video Streaming With Virtual Reality Glasses During Arteriovenous Fistula Needle Insertion on Pain and Anxiety of Individuals Undergoing Hemodialysis Treatment. Hemodial Int. 2025 Jul 24. doi: 10.1111/hdi.70010. Online ahead of print.

Reference Type: DERIVED

PMID: 40702947 (View on PubMed)

Other Identifiers

ERU-SBF-SS-38

Identifier Type: -

Identifier Source: org_study_id