Virtual Reality-Assisted Nursing Intervention During Intrauterine Device Insertion (VR-IUD)

The study's hypotheses:

Individuals receiving the virtual reality-supported nursing intervention (experimental group), compared to the control group (not individuals receiving the virtual reality);

• experience a lower level of pain during the procedure.
• experience lower levels of anxiety during the procedure.
• exhibit lower levels of stress response in physiological parameters (heart rate, blood pressure and respiratory rate).
• experience higher levels of comfort during the procedure. Condition or illness: Pain, anxiety, physiological parameters and comfort levels of individuals during IUD insertion Intervention: Virtual reality-assisted nursing intervention Stage: Women who have decided to have an IUD fitted Detailed Description Study Design Study Type: Interventional (Clinical Study) Actual Number of Participants: 70 participants Assignment: Random Intervention Model: Parallel Assignment Intervention Model Description: Prospective, parallel, two-arm, randomized controlled clinical trial, single-blind Blinding: Single (participant) Methods: The sample size was calculated using G*Power 3.1.9.4 software, based on a significance level of 5% (α = 0.05), a statistical power of 95%, and an effect size of 0.40, resulting in a minimum required sample of 64 participants (experimental = 32, control = 32).

Within the scope of the study, a total of 89 women were approached, and 12 declined to participate. Considering potential data loss, 77 participants were enrolled in the study. Following the pre-test, 7 participants who did not meet the inclusion criteria were excluded. No participants withdrew during the intrauterine device insertion procedure, and the study was completed with 70 participants (experimental = 35, control = 35).

Figure 1. CONSORT flow diagram

Randomisation and Groups In this study, given the nature of the intervention, it was anticipated that conducting the experimental and control groups on the same day could lead to information transfer between participants via communication (contamination) and behaviour changes related to the intervention (Hawthorne effect). Furthermore, administering the virtual reality application to some participants whilst not administering it to others within the same clinical setting could create a perception of unequal treatment among individuals, which could influence the study results.

Therefore, to minimise the risk of contamination and maintain the integrity of the clinical trial, participants were assigned to groups on a day-by-day basis. Participants who enrolled on specific days of the week were included in the experimental group, whilst those who enrolled on other days were included in the control group.

The similarity of baseline characteristics between the groups will be assessed statistically.

Intervention

Experimental Group (individuals receiving the virtual reality):

Participants in the experimental group were subjected to a virtual reality-assisted nursing intervention during the IUD insertion procedure. As part of this, participants were shown a 3D video lasting approximately 6 minutes, featuring nature-themed scenes (water, forest, sky) and accompanied by soothing music, via virtual reality goggles.

This intervention was designed as a non-pharmacological nursing intervention aimed at diverting the individual's attention away from the procedure and reducing pain and anxiety levels.

Control Group (not individuals receiving the virtual reality):

Participants in the control group will not receive any additional interventions beyond the routine care provided in the clinic during the IUD insertion procedure.

Data Collection Tools Data were collected in three phases: pre-procedure, during the procedure, and post-procedure.

Pre-procedure: A 7-item Information Form comprising demographic and descriptive characteristics; a 48-items the General Comfort Scale (GCS) and a 4-item Visual Analogue Scale (VAS) assessing anxiety, fear/apprehension, irritability and satisfaction regarding the IUD procedure, and by assessing blood pressure, pulse and respiratory rate.

During the procedure, pain levels immediately following the insertion of the speculum, tenaculum and IUD will be assessed using the VAS, and the pulse will be checked at each stage.

Five minutes after the procedure, blood pressure, pulse, and respiratory rate were assessed, and a 5-item VAS covering pain, tension, fear/anxiety, irritability, and satisfaction regarding the IUD insertion will be administered, along with the General Comfort Scale.

The study data were collected between February 2024 and December 2025. Ethical approval was obtained from the SANKO University Clinical Research Ethics Committee with decision number 2023-24. Informed consent was obtained from the participants.

General Comfort Scale: Developed by Kolcaba in 1992, and with Turkish validity and reliability studies conducted by Kuğuoğlu & Karabacak in 2008, this is a four-point Likert-type scale consisting of three sub-dimensions (comfort, relaxation, superiority) and 48 items. The scale includes both positive and negative items, with negative items being reverse-coded. The total score obtained from the scale is divided by the number of items to find the average score. The minimum score on the scale is 48, and the maximum is 192. Based on the average scores obtained from the comfort scale, a score of 0-48 indicates a poor level, 49-96 indicates a moderate level, 50-144 indicates a good level, and 145-192 indicates a very good level. A higher score indicates a high level of comfort. The Cronbach's alpha value of the Turkish form of the scale is .85. In this study, both groups were evaluated together and the score was found to be 0.815 based on pre-test results.

Visual Analog Scale (VAS): Created by Albersnagel (1998), the VAS is a measurement tool in which each of 18 emotion expressions is placed on a separate plane. The scale consists of emotion adjectives where the person marks each emotion they are currently experiencing with a vertical line on a plane. Each emotion is rated between not experiencing the emotion at all (e.g., not at all tense = 0) and being fully experienced (e.g., extremely tense = 100). The VAS evaluates four emotion categories: Dysphoria, Hostility, Anxiety, and Positive Affect. Dysphoria includes adjectives such as depressed, sad, mournful, distressed, hopeless, and miserable. Hostility includes adjectives such as angry, rebellious, restless, and hostile. Anxiety includes adjectives such as anxious, uneasy, tense, and nervous. Positive Emotion consists of the adjectives happy, content, cheerful, and satisfied. Scoring is based on measuring the vertical markings made by the participant for each emotion on a plane using a ruler. Positive emotion adjectives are items that are reversed during scoring. In the Turkish validity and reliability study by Aydın et al. (2011), the scale was grouped under three factors: anxiety/unease, hostility, and positive emotion. The distribution of emotions according to these factors consists of the adjectives: Anxiety/Unease (depressed, sad, sorrowful, in distress, hopeless, miserable, worried, anxious, uneasy, tense, restless), hostility (angry, rebellious, irritable), and positive emotion (happy, content, cheerful, satisfied). According to the Turkish validity and reliability study, the Cronbach Alpha coefficients of the scale were found to be .93 for the Anxiety/Unease factor, .84 for the Positive Emotion factor, and .73 for the Hostility factor.

Materials to be Used in the Study:

1. Virtual Reality Headset: Samsung GarVR2 SM-R321NZWATUR Virtual Reality Headset
2. Video Prepared for the Virtual Reality Environment: As part of the study, the experimental group will be shown a virtual reality video titled 'Virtual Nature 360° - 5K Nature Meditation for Daydream, Oculus, Gear VR', which features nature scenes accompanied by calming music.

Data Collection Data will be collected by trained researchers using the face-to-face interview method. The data collection process will take an average of 15-20 minutes.

Participants will be informed about the research and an "Informed Consent Form" will be administered. The researcher will know who is in the experimental and control groups, but participants will not know which group they belong to. Participants will be blinded. Due to the nature of the research, the researcher cannot be blinded. When the research is complete, the data will be transferred to a computer environment by an independent researcher who does not know groups A and B, and the data will be analyzed by a statistician and the findings reported.

Statistical Analysis Data analysis will be conducted using the SPSS programme.