Effect of Virtual Reality-Assisted Nursing Intervention on Pain and Anxiety During Intrauterine Device Insertion: A Randomized Controlled Trial

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