Effect of Infrared-Assisted Intravenous Catheterization on Patient Comfort and Nurse-Patient Trust 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 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 a 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 practitioner nurse obtained the group allocation by telephone from the researcher holding the list.

MASKING:

Masking of the practitioner nurse and the patient was not possible because the device projects visible light onto the skin. Procedure data (T1) were collected by a trained data collector using structured observation forms and a digital stopwatch. Post-procedure outcomes (T2) were assessed by an independent researcher who was blinded to group allocation. Because some patients spontaneously disclosed the method used, masking at T2 is considered partial.

SAMPLE SIZE:

Calculated with G*Power 3.1.9.7 (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), Peripheral Intravenous Catheterization Comfort Scale (PIVCCS) and Trust in Nurses Scale.

STATISTICAL ANALYSIS:

Quantitative data were analysed with IBM SPSS Statistics 27 in the modified intention-to-treat set; significance was set at p < 0.05 (two-sided). Because the comfort and trust scores were skewed with ceiling effects, between-group comparisons used the Mann-Whitney U test with effect size r and Hodges-Lehmann median difference estimates (95% CI). Categorical variables were compared with Pearson's chi-square test or Fisher's exact test. Baseline balance was assessed with standardized differences. Adjusted analyses used ANCOVA (covariates: A-DIVA score and baseline VAS), with rank-based ANCOVA as a robustness check, and binary logistic regression for first-attempt success. Subgroup analyses by A-DIVA risk category were exploratory. Internal consistency 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: NIR-assisted PIVC significantly increases patient comfort compared to standard method H2: NIR-assisted PIVC significantly reduces procedural pain H3: NIR technology positively affects nurse-patient trust relationship H4: Patients experience NIR technology as safe, comfortable, and preferable

Inclusion criteria

• Aged 18 years or older
• Histopathologically confirmed lung cancer (small cell or non-small cell)
• Receiving active systemic chemotherapy (at least one cycle completed)
• Indication for a peripheral intravenous catheter for chemotherapy administration
• Able to speak and understand Turkish sufficiently to communicate
• Read and signed the informed consent form

Exclusion criteria

• Situations requiring emergency or life-saving catheterization
• Presence of a central venous catheter (port, PICC or tunneled catheter)
• Anatomical anomaly, amputation, post-mastectomy lymphedema or arteriovenous fistula in both upper extremities
• Active local infection, dermatitis or impaired skin integrity at the planned catheterization site
• Altered consciousness or disorientation
• Mediastinal, supraclavicular or infraclavicular mass/lymphadenopathy that may affect upper extremity venous return

Withdrawal Criteria:

• Withdrawal of consent at any stage
• Need for an off-protocol intervention (decision for central access after failure at the third attempt)
• Development of an acute clinical condition preventing completion of data collection