Comfort Communication Model Intervention for Burn Pain and Pain Anxiety

Baskent University

Status: Begins enrollment this month

Conditions: Nursing Interventions; Burn Patients; Pain Management

Treatments: Other: Comfort Communication Model

Study type: Interventional

Funder types: Other

Identifiers

NCT07385339

TABED 2-25 - 1466

Details and patient eligibility

About

This single-center, randomized controlled trial will evaluate the effect of a nursing intervention based on the COMFORT Communication Model on procedural pain and burn-specific pain anxiety in adult outpatient burn patients undergoing routine dressing changes at the Adult Burn Center Outpatient Unit of Ankara Bilkent City Hospital. Burn dressing changes are frequently perceived as one of the most painful non-surgical procedures, and repeated exposure to wound care may contribute to anticipatory anxiety and stress, potentially creating a reinforcing cycle in which anxiety amplifies pain and pain increases anxiety. In outpatient burn care, effective nurse-patient communication may play a critical role in improving comfort, supporting coping, and enhancing engagement in ongoing treatment.

Eligible participants will be adults aged 18 years and older with second- or third-degree burns who have experienced at least three prior dressing changes, can communicate in Turkish, and have no major hearing or cognitive impairment or comorbid psychiatric/neurological condition that would prevent understanding of the study procedures. Participants who request withdrawal, require hospitalization during follow-up, or miss two consecutive intervention sessions will be withdrawn from the study. The required minimum sample size was estimated as 62 patients (31 per group) based on power analysis (effect size f=0.30; 80% power).

After providing written and verbal informed consent, participants will be randomly assigned (simple randomization using Random Allocation Software) to either the COMFORT-based communication intervention group or the usual care control group. Data will be collected face-to-face in a quiet and private environment during dressing visits. At the initial visit, participants in both groups will complete a sociodemographic and burn-related information form and baseline assessments. Pain intensity will be evaluated using a Verbal Rating Scale and a Numeric Rating Scale, and pain anxiety will be assessed using the Burn-Specific Pain Anxiety Scale; perceived stress will also be measured.

The intervention will be delivered by a wound care nurse during three consecutive dressing sessions. Each session is structured to last approximately 10 minutes and uses specific components of the COMFORT Communication Model tailored to the dressing-change context. In Session 1, the focus is on establishing trust, providing clear information, and supporting patient control through Connection/Communication, Orientation and opportunity, and Relating strategies (e.g., explaining the procedure step-by-step, checking understanding, offering supportive options, and inviting the patient to signal if they want pauses). In Session 2, the focus shifts to creating space for emotions and strengthening supportive openings using Mindful communication, Openings, and Family components (e.g., exploring how the prior session felt, inviting expression of concerns, and identifying supportive persons). In Session 3, communication emphasizes personalization, meaning-making, and teamwork by integrating Relating, Team, and Meaning-focused prompts (e.g., reflecting on what was most helpful, supporting adaptive coping, and, if appropriate, facilitating communication with the clinical team). Throughout all sessions, routine wound care will continue as standard practice in both groups.

Outcomes will be assessed repeatedly across the three dressing sessions. Pain and pain anxiety will be assessed before each dressing, and follow-up assessments will be repeated approximately 30 minutes after the dressing procedure. The primary objective is to determine whether COMFORT model-based nursing communication reduces procedural pain intensity and burn-specific pain anxiety compared with usual care during outpatient dressing changes. A secondary objective is to evaluate whether the intervention reduces perceived stress across sessions. Statistical analyses will include appropriate descriptive and repeated-measures comparisons to examine group differences over time.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 18 years of age or older,
• Patients with at least three dressing experiences
• Patients with 2nd and 3rd degree burns
• No difficulty communicating in Turkish,
• No hearing problems or cognitive impairment,
• No additional mental disorders,
• Willingness to cooperate,
• No additional mental disorders,
• Ability to perform self-care,
• Patients who voluntarily agreed to participate in the study

Exclusion criteria

• First-time burn care dressing
• Having a first-degree burn
• Actively receiving inpatient treatment
• Having a neurological or psychiatric condition that prevents reading and understanding data collection tools
• Having difficulty speaking/understanding Turkish

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Comfort Communication Model Group

Experimental group

Description:

Participants will receive routine outpatient burn dressing care plus a structured COMFORT Communication Model-based nursing communication intervention delivered face-to-face by a wound care nurse during three consecutive dressing visits. Each session lasts \~10 minutes and is implemented during the dressing procedure in a quiet, private setting. Session 1 focuses on building trust, explaining steps, checking understanding, and supporting patient control (Connection/Communication; Orientation and opportunity; Relating). Session 2 focuses on emotional expression and supportive openings (Mindful communication; Openings; Family). Session 3 emphasizes personalization, teamwork, and meaning-making (Relating; Team; Mindful communication). Pain and burn-specific pain anxiety are assessed before each dressing and again \~30 minutes after; final assessment occurs after the 3rd visit.

Treatment:

Other: Comfort Communication Model

Rutin Care Group

No Intervention group

Description:

Participants will receive routine outpatient burn dressing care only, without the structured COMFORT-based communication sessions. Baseline data are collected at the first visit, and outcomes are assessed on the same schedule as the intervention arm. Pain and burn-specific pain anxiety are evaluated before each dressing and again \~30 minutes after each procedure, with follow-up assessments completed at the third dressing visit.