Skip to main content
OpenTrials
Completed

NCT Number: NCT06776497

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes Üniversty

Kayseri, Talas, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

VIRTUAL REALITY GLASSES (VRG)

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.

Primary outcomes

  1. The Visual Analogue Scale (VAS)

    Time frame: one week

    The Visual Analogue Scale (VAS) is a tool used to assess the severity of pain. The visual analog scale is a pain rating scale first used by Hayes and Patterson in 1921. It is used to quantify pain that cannot be measured numerically. Two extreme definitions of the pain parameter are written on the two ends of a 100-mm strip, and the patient is asked to indicate where his or her condition fits on this strip by drawing a line, dotting, or marking. It was also found that this scale was easy to understand and applicable for patients over five years of age and was a successful method for assessing the effectiveness of the pain relief method applied. It is a 100-mm (10-cm) ruler that can be used either horizontally or vertically, with no pain at one end and the worst pain at the other end."0 mm" indicates no pain, and "100 mm" indicates the worst pain. The individual indicates the severity of pain felt on this ruler. Based on these data, the horizontally prepared VAS was used to identify th

  2. State-Trait Anxiety Inventory

    Time frame: one week

    State-Trait Anxiety Inventory was developed by Spielberger et al., to assess state and trait anxiety levels and adapted into Turkish by Öner and Lecompte.The scale is based on the two-factor anxiety concept. The Kuder-Richardson reliability of the inventory was found to range from 83 to 87 for the trait anxiety subscale and 94 to 96 for the state anxiety subscale.

    The test-retest reliability rates of the inventory ranged from 71 to 86 for the trait anxiety subscale and from 26 to 68 for the State Anxiety subscale and were considered adequate.In this study, Cronbach's alpha reliability coefficient of the State-Trait Anxiety Inventory was found to be 0.73 for the State Anxiety Inventory and 0.75 for the Trait Anxiety Inventory. The State-Trait Anxiety Inventory consists of a total of 40 items. The first 20 items assess the state-related anxiety level, while the items from 21 to 40 assess the trait anxiety level of the individual.

Sponsors and collaborators

Lead sponsor

Selcuk Ozturk

Other

Collaborators

  • TC Erciyes University

Registry information

Official study title

The Effect of Vıdeo Streaming with Vırtual Realıty Glasses Durıng Arterıovenous Fıstula Needle Insertıonon on Paın and Anxıety of Indıvıduals Undergoıng Haemodıalysıs Treatment

Acronym: Pain

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.