NCT07385339

Comfort Communication Model Intervention for Burn Pain and Pain Anxiety

The Effect of a Nursing Intervention Based on the Comfort Communication Model on Pain and Pain Anxiety in Outpatient Burn Patients: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Baskent University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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who request withdrawal, require hospitalization during follow-up, or miss two consecutive intervention sessions will be withdrawn from the study.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.

Detailed description

The majority of patients with burn injuries are treated on an outpatient basis, while those requiring inpatient care in the burn unit need intensive and prolonged treatment and care. All patients hospitalized or treated on an outpatient basis due to burns must cope with pain arising from the burn itself and from procedures performed during burn treatment. Burn patients experience three types of pain: procedural pain, resting pain, and sudden pain. Procedural pain experienced by burn patients during dressing changes is considered the most painful of all non-surgical procedures. During this process, nurses should prioritize the patient's complaints and provide effective pain management by frequently inquiring about the intensity and characteristics of the pain. The repetition of procedures performed at specific intervals, such as wound care, and the patient's awareness of this cycle can cause the development of anticipatory anxiety in the patient. The literature reports a relationship between dressing changes and increased pain, anxiety, and stress, and that anxiety negatively affects wound healing. In a study by Dehghani et al. examining the relationship between pain and anxiety during wound care in burn patients; it was reported that pain experienced during wound care was associated with burn-specific pain anxiety, and that nurses' assessment of patients' pain and its reduction using pharmacological and non-pharmacological methods were of great importance for patients' physical and psychological health. Nurses who provide holistic care to burn patients play important roles in diagnosing patients' pain and anxiety levels, ensuring pain control, and reducing their anxiety. Pain and anxiety are interrelated factors in burn patients. Patients' pain expectations and experiences lead to varying levels of anxiety, and it has been shown that pain and anxiety are intertwined, creating a vicious cycle. Karakteke and other researchers have emphasized that there is a direct relationship between burn patients' pain and anxiety levels; inadequate pain or anxiety management can negatively affect recovery and rehabilitation processes. Furthermore, the literature indicates that anxiety levels are related to the patient's coping skills, quality of life, and participation in rehabilitation. Uncontrolled pain causes stress and fear in burn patients, intensifying anxiety, which in turn reduces treatment satisfaction and overall psychological well-being. Nurse-patient communication plays a critical role in this process. Effective communication is known to facilitate pain control and improve the patient's psychological state. For example, in the study by Tetteh et al., nurses stated that open communication supported patients' pain management and increased their participation in treatment by identifying their concerns early. Conversely, when communication is lacking, patient cooperation decreases, and patients are forced to cope with their pain on their own. Therefore, researchers recommend increasing patient-centered communication and ensuring that nurses receive adequate training in this area, given that pain is a subjective experience. Good communication is thought to reduce anxiety levels by making the patient feel understood and to strengthen compliance with treatment. At this point, evidence-based communication models gain importance. Wittenberg's COMFORT Communication Model is a framework that includes seven core components (Connection, Options, Meaning, Family/Support Person, Opening, Intimacy, and Team) aimed at establishing effective communication with patients and families in nursing. This model guides nurses in providing patient-centered care by strengthening their ability to establish empathetic closeness and explain care options. Structured communication and education-based nursing interventions have been shown to yield positive outcomes in burn patients. For example, multimedia-supported psychosocial education programs have strengthened burn patients psychologically and improved their quality of life. Similarly, self-care-focused nursing interventions have also significantly improved patients' self-esteem and quality of life. The clinical application of this developed model and its inclusion in the education system have been investigated. Research has shown that when the COMFORT communication model specific to palliative and end-of-life care is applied, close and effective communication is established between the nurse, patient, and family, and nurses feel more comfortable. This dynamic communication model illustrates the interaction of seven core principles. C (Communication): Communication defines the importance of clarity in communication, along with the use of verbal and nonverbal communication techniques (such as leaning forward and making eye contact).O (Orientation and opportunity): Orientation and opportunity involves knowing the health literacy of the patient and family and incorporating the cultural background of the patient and family into the presentation of information. M (Mindful communication): Mindful communication is active and empathetic listening, the desire to be present and attuned to the pain of the patient and family. F (Family): Family and patient are intertwined, so caregivers must understand the patterns of conversation and harmony within all families. O (Openings): Openings often occur at times when significant privacy is required; nurses offer patients and families alternatives for therapeutic care through communication strategies and also help manage anxiety-provoking situations. R (Relating): Relating requires acknowledging that patients and families need time to accept the diagnosis and prognosis. T (Team): Team demonstrates the interprofessional group interaction and skills needed to provide high-quality palliative and end-of-life care. In light of these data, the application of a communication-based approach such as the COMFORT Communication Model in the context of burn care has the potential to improve well-being by reducing patients' pain anxiety and psychological burden. The aim of this study is to examine the effect of a nursing intervention based on the Comfort Communication Model on pain and pain anxiety in outpatients with burns. Research Hypotheses: H1-1: Individuals who are treated with the COMFORT Communication Model during burn dressing have lower pain levels. H1-2: Individuals who are treated with the COMFORT Communication Model during burn dressing have lower pain anxiety levels. METHODS Study DesignThis research is designed as a randomized controlled trial (RCT) with repeated measures, including baseline (pre-test), and post-test. Participants will be randomly assigned to either the intervention group (receiving COMFORT communication model) or the control group (receiving standard care).Participants: -Be 18 years of age or older, -patients with at least three dressing experiences; -Patients with second- and third-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 agree to participate in the study will be included. Exclusion criteria for the study: -Having a neurological or psychiatric disorder that prevents reading and understanding the data collection tools; -Having difficulty speaking/understanding Turkish. Criteria for exclusion from the study: -Wanting to withdraw from the study; -Being hospitalized during the study; -Failing to attend two consecutive sessions of the intervention. The analysis conducted using G power determined that a minimum sample size of 68 patients is required for the study. This includes 34 participants in the group where the COMFORT Communication Model will be applied and 34 participants in the control group. The sample will be distributed approximately equally across the groups, with an effect size of f=0.30, to achieve a test power of 80% and a confidence level of 95%. Research Material: The COMFORT Communication Model will be applied to the sample in the study. In this context, communication will be maintained according to the steps of the COMFORT Communication Model in each session. Research Variables: Independent variables: Information regarding patients' sociodemographic data. Dependent variables: Scale scores (Verbal Category Scale, Numerical Rating Scale, Burn-Specific Pain Anxiety Scale scores) Data Collection Tools: The Sociodemographic Data Collection Form, Verbal Category Scale, Numerical Rating Scale, and Burn-Specific Pain Anxiety Scale, prepared in line with the relevant literature within the scope of the study, will be used to collect data. Sociodemographic Data Collection Form: The "Sociodemographic Data Collection Form," created by researchers based on a review of the literature, consists of sociodemographic information and questions related to burns. The sociodemographic data section of the form includes questions about age, gender, marital status, economic status, number of children, family type, educational status, employment status, presence of a caregiver, smoking and alcohol use, additional chronic diseases, and additional medication use. The burn-related data section of the form includes questions such as burn degree, burn percentage, burn type, burn shape, burn location, time elapsed since the burn, presence of organ loss due to the burn, previous burn experience, number of dressings, and other treatment methods applied as part of burn treatment (such as graft, flap, excision). Verbal Rating Scale: Verbal scales are also referred to as simple/descriptive scales, and with this scale, the patient selects the most appropriate word to describe their pain, and the assessment is made. Pain intensity ranges from mild pain to unbearable pain. Verbal scales are generally 4 or 5-item scales, and patients are asked to evaluate their pain by selecting the word that describes their pain. The VAS used in this study is a 5-item scale and will be rated as follows: 1; "Mild", 2; "Annoying", 3; 'Severe', 4; "Very severe" and 5; "Unbearable". Numerical Rating Scale: Numerical scales are among the most commonly used unidimensional pain intensity scales because they are easy to use and effective. Patients are asked to select the number between 0 and 10, 0 and 20, or 0 and 100 that best matches their pain intensity. Zero indicates no pain, while the highest number represents the worst pain imaginable.Numerical scales are frequently preferred in practice because they are easy to use and effective; they are useful in defining pain intensity, scoring, and recording. In this study, the NPS consisting of numbers between 0 and 10 was used. According to the scale, 0 means no pain, 1-3 means mild pain, 4-6 means moderate pain, and 7-10 means severe pain. Burn-Specific Pain Anxiety Scale: Developed by Taal and Faber in 1997, the BSPAA consists of 9 items in its original language. This scale, developed to measure pain in burn patients, was validated in Turkey in 2019 by Arslan and colleagues. The Turkish version of the scale consists of 8 items and is a two-ended visual analog scale ranging from 0 to 10. The reference points are defined by the expressions "none" (0) and "the worst possible" (10). The total scale score is calculated by adding up the scores of all items, with the lowest score being 0 and the highest being 80. The higher the total score, the higher the anxiety experienced by the patient regarding painful procedures during their hospital stay. The Cronbach's α coefficient of the Turkish version of the scale was found to be 0.95. Preliminary Application of the Study: A preliminary application will be made on 10% of the sample. Necessary adjustments will be made in line with the recommendations. Research Implementation Process: The research data will be collected by the researcher through face-to-face interviews with individuals receiving outpatient burn treatment. In the study, the researcher will provide information about the research to patients who meet the sample criteria, and those who agree to participate in the research will be randomized into an experimental and a control group. A simple randomization method will be used for randomization, and the experimental groups and control group will be determined using Random Allocation Software. The first interview will be conducted in a calm and quiet environment, ensuring privacy for the individuals in the experimental and control groups during dressing changes. The purpose of the research will be explained to the individuals during the first interview, which is expected to last an average of 20 minutes. Data will be collected from individuals in the experimental and control groups using a sociodemographic information form, Verbal Category Scale, Numerical Rating Scale, and Burn-Specific Pain Anxiety Scale. The COMFORT Communication Model will be applied to individuals in the experimental group. Initial data will be collected from individuals in the experimental and control groups after the first interview. Data from individuals who have undergone the COMFORT Communication Model will be collected through face-to-face interviews after the third dressing session. In addition, any questions the experimental group individuals may have regarding treatment will be answered. The control group will receive verbal information using the data collection form, Verbal Category Scale, Numerical Rating Scale, and Burn-Specific Pain Anxiety Scale, and will continue to receive routine care. Data will be collected through face-to-face interviews with the control group after the first interview and when they come for treatment for the third dressing session. There are sample statements according to the COMFORT Communication Model during dressing sessions. 1\. Session: Duration: 10 min; Basic Structure: Information - Action - Feedback, Communication focus: Building trust and providing information; Model emphasis: C: Communication; O: Orientation and opportunity; R: Relating 2nd Session: Duration: 10 min; Basic Structure: Brief recap - Process - Expression of feelings; Communication focus: Creating an emotional support and expression space; Model emphasis: M: Mindful communication; O: Openings; F: Family 3rd Session: Duration: 10 min; Basic Structure: Customization - Process - Meaning-making; Communication focus: Maintaining the relationship and personalization; Model emphasis: R: Relating; T: Team; M: Mindful communication 1. SESSION - BEGINNING AND TRUST: Focus: -Providing information, building trust, instilling a sense of control; -The procedure is explained in clear and informative language.; -Questions about anxiety and pain are addressed directly. The steps of the procedure are explained in a calm tone of voice. Sample phrases: -"Would you like anything to help you relax?" (C: Communication); -"Welcome. Today's dressing procedure will take about 10 minutes, and we will proceed step by step together." (C: Communication); -"We will explain each step to you before starting the procedure. We can begin when you are ready." (O: Orientation and opportunity); -"You may feel some stinging during this procedure, but you are completely in control. Please let us know if there is any moment when you do not want us to continue." (R: Relating); -"Is there anything that would make you feel more comfortable? Such as playing music or taking deep breaths..." (O: Opening); 2. SESSION - MAKING ROOM FOR EMOTIONS: Focus: Verbalizing anxiety, creating space for emotions; -The evaluation will begin with the question, "How was your experience during the first session?";- If the patient needs to express themselves during the procedure, space will be provided. Sample Statements: * "How do you feel today compared to the last dressing?" (M: Mindful communication); -"These procedures can sometimes be physically and emotionally challenging. What is the most challenging for you?" (O: Orientation and opportunity); -"If there is a moment when you don't feel comfortable, I want to hear about it. The more I know, the more I can help." (O: Opening); -"Who has been your biggest support during this process? How does their presence make you feel?" (F: Family) 3rd SESSION - PERSONALIZATION AND MEANING: Focus: Strengthening the relationship, creating meaning, closing the process; -Start with "What would be most comforting for you today?";-The patient is guided based on their previous experiences. The session will end with the question, "How did you experience this process? What did it mean to you?" Sample statements: -"We have had three dressings together so far. What do you think this experience has added to you?" (O: Opening);-"What was the most comforting thing for you today? I would like to know this for your future care." (M: Mindful communication); -"As someone who has gone through this process, what would you like to say to others?" (R: Relating); -"If you wish, we can share your feelings with your doctor. We can evaluate this information with the team and make the best plan for you." (T: Team); Additionally, at the beginning of each session, personalized statements such as: "At the end of the last session, you mentioned that 'this part was challenging for me.' Let's focus on that today." or "In our previous sessions, you mentioned that listening to music was beneficial for you. Would you like to do that today?" will be used. Statistical Evaluation of Data: In the study, frequency (n) and percentage (%) values will be used as descriptive statistics in the evaluation of categorical variables. Shapiro-Wilk test will be used for the conformity of numerical variables to normal distribution and as descriptive statistics; mean ± standard deviation values will be given for variables suitable for normal distribution and median (minimum-maximum) values will be given for those that do not fit the normal distribution. The appropriate hypothesis testing method planned to be used in the study was determined as a "Two-Way Analysis of Variance with Repetitions on a Single Factor" when parametric test assumptions are met. In examining whether there is a difference between groups in terms of numerical measurements, it will be examined by "Analysis of Variance" if parametric test assumptions are met, and by "Kruskal-Wallis Test" not; In examining the repetitions of numerical measurements at 2 different times, it will be examined by "Repeated measures ANOVA" if test assumptions are met, and by "Friedman test" not. In examining the relationships between variables, if the test assumptions are met, "Pearson correlation analysis" will be performed, if not, "Spearman correlation analysis" will be performed. In examining the relationship between categorical variables, "The Pearson Chi-Square Test" will be used when the test assumptions are met, and "The Fisher Exact Test" will be used when the test assumptions are not met. In all hypothesis tests, Type I error probability will be taken as α=0.05, and the SPSS v25.0 package program will be used for statistical evaluations.Ethical Considerations: Ethical approval will be obtained from the Ankara Bilkent City Hospital Ethics Committee. Written informed consent will be secured from all participants. The study complies with Helsinki Declaration principles.Expected ContributionsThis study will provide novel insights into the applicability of COMFORT Communication models in burn patients, offering an alternative evidence-based psychological intervention for improving burn pain, burn spesicifc pain anxiety and mental health. If effective, COMFORT Communication models could be integrated into standard psychosocial care for burn patients, enhancing their quality of life.

Conditions

• Burn Patients
• Pain Management
• Nursing Interventions

Interventions

Type	Name	Description
OTHER	Comfort Communication Model	COMFORT Communication Model-based nursing communication intervention delivered during outpatient burn dressing changes. Participants in the intervention arm receive three consecutive sessions (\~10 minutes each) provided face-to-face by a wound care nurse in a quiet, private setting while routine wound care continues. The nurse uses structured communication aligned with COMFORT components across sessions: Session 1 emphasizes Communication/Connection, Orientation and opportunity, and Relating (clear step-by-step explanation, checking understanding, offering options such as pauses/coping strategies, supporting patient control). Session 2 emphasizes Mindful communication, Openings, and Family (exploring prior experience, inviting emotional expression, identifying supportive persons). Session 3 emphasizes Relating, Team, and Meaning/Mindful communication (personalizing support, reflecting on what helped, meaning-making, and facilitating communication with the care team when appropriate). P

Timeline

• Start date: 2026-02-17
• Primary completion: 2026-05-08
• Completion: 2026-06-10
• First posted: 2026-02-04
• Last updated: 2026-03-02