Effect of Infrared-Assisted Intravenous Catheterization on Patient Comfort in Lung Cancer Patients

BACKGROUND:

Peripheral intravenous catheterization (PIVC) is one of the most common invasive procedures in clinical practice. In patients receiving chemotherapy, repeated venous access and chemotherapy-related vascular damage can make catheterization difficult and can increase the number of attempts, pain and discomfort. Near-infrared (NIR) vein visualization devices project a real-time map of superficial veins onto the skin and may help the nurse select a suitable vein.

STUDY DESIGN:

Explanatory sequential mixed-methods design (QUAN→qual). The sequential nature of the design was established at the level of analysis and integration. Because patients in the outpatient unit could not easily be reached again after treatment, qualitative interviews were conducted during the same period as quantitative data collection; qualitative analysis and integration were performed after the quantitative analysis was completed. The trial is reported according to CONSORT 2025, the qualitative component according to COREQ and the mixed-methods integration according to GRAMMS.

Phase 1 (Quantitative): Single-centre, parallel-group (1:1), two-arm, open-label randomized controlled trial.

• Intervention group (80 randomized): PIVC assisted by an NIR vein visualization device.
• Control group (80 randomized): PIVC using the unit's routine method (visual inspection and palpation) without any technological assistance.
• Both groups followed the same standard procedure with consumables from a single brand and lot group. A maximum of three attempts was allowed.

Phase 2 (Qualitative): Qualitative descriptive design. Semi-structured individual interviews were conducted with 11 purposively selected patients from the intervention group after the T2 measurements. Interviews were audio recorded, transcribed verbatim and analysed with hybrid (deductive and inductive) qualitative content analysis. Coding was performed independently by the researcher and the thesis supervisor. Adequacy of the qualitative sample was assessed with the information power criterion. (The initial protocol planned a phenomenological approach with 15-20 patients.)

PRACTITIONERS:

The initial protocol planned a single practitioner nurse. Because this was not feasible given the patient volume and task distribution of the unit, catheterizations were performed by the unit nurses within their routine weekly rotation. All 7 nurses received the same structured device training and completed a clinical run-in period of at least two weeks before data collection. All had at least five years of experience with the conventional method (mean 13.57 years, range 9-18). Because randomization was performed at the patient level, each nurse performed procedures in both groups.

RANDOMIZATION AND ALLOCATION CONCEALMENT:

A computer-generated randomization list in blocks of four (Research Randomizer, www.randomizer.org) was prepared by the thesis researcher, who was not involved in the clinical conduct of the study. After eligibility was confirmed, informed consent was obtained and baseline measurements were completed, the data collector obtained the group allocation by telephone from the researcher holding the list and informed the practitioner nurse (central telephone allocation).

MASKING:

This was an open-label trial. Masking of patients and practitioner nurses was not possible because the NIR device projects visible light onto the skin. All data (T0, T1 and T2) were collected by the same trained data collector, who learned the group allocation before the procedure and was therefore not blinded. To limit measurement bias, structured observation forms, predefined operational criteria and standard written instructions for each measurement tool were used. Statistical analyses were performed with group labels visible.

SAMPLE SIZE:

Calculated with G*Power 3.1.9.7 for the primary outcome (PIVCCS) (two-sided alpha = 0.05, power = 0.80, Cohen's d = 0.50): a minimum of 64 patients per group, increased to 80 per group (160 in total) to allow for 20% attrition. All 160 patients were randomized. After randomization, 30 patients (18.75%; 15 per group) were removed because of voluntary withdrawal, duplicate records or incomplete forms, and 130 patients (65 per group) were included in the modified intention-to-treat analysis.

DATA COLLECTION TIMEPOINTS:

T0 (before the procedure): patient information form, baseline pain (VAS) and Adult Difficult Intravenous Access (A-DIVA) score.

T1 (during the procedure): first-attempt success, total number of attempts, total procedure duration (from tourniquet application to successful fixation of the catheter, in seconds), catheter size and site, and complications (hematoma, extravasation, adverse events).

T2 (after the procedure; starting 5 minutes after the patient returned to the treatment chair and before the chemotherapy infusion): procedural pain (VAS) and Peripheral Intravenous Catheterization Comfort Scale (PIVCCS).

STATISTICAL ANALYSIS:

Quantitative data were analysed with jamovi (version 2.7.16) in the modified intention-to-treat set (n=130); significance was set at p < 0.05. Normality was assessed with the Kolmogorov-Smirnov test. Because the outcome variables were not normally distributed, between-group comparisons used the Mann-Whitney U test (effect size: rank-biserial correlation), within-group comparison of pre- and post-procedure pain used the Wilcoxon signed-rank test, and categorical variables were compared with Pearson's chi-square test or Fisher's exact test. Baseline balance was assessed with standardized differences. Supplementary adjusted analyses used ANCOVA (covariates: A-DIVA score and baseline VAS), with rank-based ANCOVA as a robustness check. Subgroup analyses by A-DIVA risk category were exploratory. Relationships between variables were examined with Spearman's rank correlation. Internal consistency of the PIVCCS was assessed with Cronbach's alpha and floor/ceiling effects with the 15% criterion.

Qualitative data were analysed with hybrid qualitative content analysis, and the two datasets were integrated with a joint display table.

HYPOTHESES:

H1: Procedure-specific comfort (PIVCCS) scores are higher with NIR-assisted catheterization than with the standard method.

H2: First-attempt success is higher, and the number of attempts and procedure duration are lower, with NIR-assisted catheterization.

H3: Post-procedure pain (VAS) is lower with NIR-assisted catheterization. H4: Procedure-related complications (hematoma, extravasation, adverse events) are less frequent with NIR-assisted catheterization.

The qualitative phase did not test hypotheses; its research question was: How do patients with lung cancer describe their experience of NIR-assisted intravenous catheterization?

CHANGES TO THE REGISTERED OUTCOMES:

Following the doctoral thesis committee review (September 2026), this record was updated to match the final analysis reported in the thesis: (1) the Trust in Nurses Scale, registered as a primary outcome, was excluded from the analysis because it showed insufficient internal consistency (Cronbach's alpha = 0.227) and a marked ceiling effect (57.7%) in this sample; (2) procedure-specific comfort (PIVCCS) is the sole primary outcome and post-procedure pain (VAS) is reported as a secondary outcome; (3) first-attempt success, number of attempts, procedure duration and complications, which were recorded at T1 as planned, were added as secondary outcomes; (4) the masking and allocation descriptions were corrected to reflect the actual conduct of the study (open label; no masking of any role).