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Набор скоро начнётся NCT07385339

Comfort Communication Model Intervention for Burn Pain and Pain Anxiety

Без фазы С лечением Burn Patients Pain Management Nursing Interventions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Comfort Communication Model.
Кому может быть актуально
Состояния в реестре: Burn Patients, Pain Management, Nursing Interventions. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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request withdrawal, require hospitalization during follow-up, or miss two consecutive intervention sessions will be withdrawn from the study.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

Подробное описание

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-

Вмешательства

  • Другое 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 (c

Первичные конечные точки

  • Burn-Specific Pain Anxiety [Срок оценки: Baseline (first visit) and across three consecutive dressing sessions (Days 1-3): assessed before each dressing and reassessed ~30 minutes after each dressing; final evaluation after the 3rd session.]
Вторичные конечные точки (1)
  • Pain Intensity During Dressing Change [Срок оценки: Baseline (first visit) and across three consecutive dressing sessions: before each dressing and ~30 minutes after each dressing (Days 1-3).]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Wittenberg-Lyles, E., Goldsmith, J., Ragan, S. ve Sanchez-Reilly, S. (2010). Dying with comfort: family illness narratives and early palliative care. Cresskill, NJ: Hampton Press.
  • Wittenberg-Lyles, E., Goldsmith, J. ve Ragan, S.L. (2010). The COMFORT initiative. J Hosp Palliat Nurs. 12(5), 282-292. https://doi.org/10.1097/ NJH.0b013e3181ebb45e
  • Wittenberg E, Ferrell B, Goldsmith J, Ragan SL, Paice J. Assessment of a Statewide Palliative Care Team Training Course: COMFORT Communication for Palliative Care Teams. J Palliat Med. 2016 Jul;19(7):746-52. doi: 10.1089/jpm.2015.0552. Epub 2016 Jun 10. PMID 27285175
  • Tetteh L, Aziato L, Mensah GP, Vehvilainen-Julkunen K, Kwegyir-Afful E. Burns pain management: The role of nurse-patient communication. Burns. 2021 Sep;47(6):1416-1423. doi: 10.1016/j.burns.2020.11.011. Epub 2020 Nov 27. PMID 33277090
  • Goldsmith JV, Wittenberg E, Parnell TA. The COMFORT Communication Model: A Nursing Resource to Advance Health Literacy in Organizations. J Hosp Palliat Nurs. 2020 Jun;22(3):229-237. doi: 10.1097/NJH.0000000000000647. PMID 32282558
  • Davodabady F, Naseri-Salahshour V, Sajadi M, Mohtarami A, Rafiei F. Randomized controlled trial of the foot reflexology on pain and anxiety severity during dressing change in burn patients. Burns. 2021 Feb;47(1):215-221. doi: 10.1016/j.burns.2020.06.035. Epub 2020 Jul 12. PMID 32739224
  • Aghakhani N, Faraji N, Alinejad V, Goli R, Kazemzadeh J. The effect of guided imagery on the quality and severity of pain and pain-related anxiety associated with dressing changes in burn patients: A randomized controlled trial. Burns. 2022 Sep;48(6):1331-1339. doi: 10.1016/j.burns.2021.11.020. Epub 2021 Nov 26. PMID 34924224

Идентификаторы

NCT: NCT07385339 · TABED 2-25 - 1466

Первоисточники (государственные реестры)

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