Use of Breathing Exercises and Stress Balls During Dressing Changes in Burn Patients

Hasan Kalyoncu University

Status: Completed

Conditions: Burns (Physical Finding); Pain Management; Stress Ball; Anxiety; Pain; Breathing Exercise

Treatments: Other: Control (Standard Treatment) Group; Other: Breathing Exercise Group; Other: Stress Ball Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07100041

HKU-SBF-SA-02

Details and patient eligibility

About

In burn patients, failure to effectively manage pain and pain-related anxiety negatively affects the healing process; therefore, pain and anxiety must be carefully managed in burn patients. In addition to managing pain and anxiety, providing comfort-based care also contributes to improving the individual's health and recovery. In this study, the effect of breathing exercises and stress ball use during dressing changes on pain, anxiety, and vital signs in burn patients will be evaluated.

Full description

Patients who visited the outpatient clinic providing services to ambulatory patients at the Burn Centre of Adana City Training and Research Hospital of the Ministry of Health of the Republic of Turkey during the study period will constitute the study population. The sample size calculation for the study was performed using the G-Power 3.1 computer program. While this study does not evaluate the effects of breathing exercises and stress balls on pain and anxiety during wound or burn dressing changes, there are studies in the literature that have evaluated the effectiveness of both methods during various invasive procedures. Considering that the stress ball and breathing exercise groups will be compared with the control group in terms of pain and anxiety averages using t, and evaluating that the effect values in the studies in the literature vary between d=0.2 and d=0.8, According to Cohen, d=0.5, with 80% power at a 95% confidence interval, the total sample size is estimated to be 196 patients, with 64 patients in each group. Considering a 10% loss rate among patients, 70 patients will be included in each group at the beginning of the study, resulting in a total of 210 patients.

Participants who meet the inclusion criteria and volunteer will be provided with information about the study, and their verbal and written consent will be obtained. Prior to the dressing procedure, the patient information form will be completed, pain levels will be recorded using the Visual Analogue Scale (VAS), vital signs will be checked, and the Burn-Specific Pain Anxiety Scale (BSPAS) will be administered. Then, the GAS will be used to assess the pain level during the dressing procedure, and the pain level will be recorded. After the dressing, vital signs will be re-checked as soon as possible, and the General Comfort Scale Short Form (GCS-SF) will be administered. Data will be collected using the same data collection tools during the patient's two consecutive dressing changes (patients' dressings are changed every two days).

Block randomisation will be used to determine the groups in the study. Participants will be assigned to groups at the time of their outpatient visit, after eligibility criteria have been assessed. The homogeneity of the groups will be determined using a web-based randomisation system, Research Randomizer (https://www.randomizer.org/). A block randomisation list will be obtained for the three groups. Patients will be assigned to the intervention groups according to the obtained randomisation list.

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between the ages of 18 and 65, seeking outpatient treatment at the burn centre,
• Without mental, hearing, visual or physical disabilities,
• Able to speak and understand Turkish,
• With a burn injury of 15% or less of the total body surface area (TBSA) and requiring dressing changes,
• At least three days have passed since the burn injury (the wound has passed the inflammatory phase of healing),
• Not in the maturation phase of wound healing,
• Burn area is on the hand, arm, leg, foot, or torso,
• No active burns on the hands,
• No respiratory issues.

Exclusion criteria

• Patients with neurological or psychiatric disorders,
• Patients with burns covering less than 15% of their body surface area or with no second-degree burns,
• Patients with burns in areas other than the hands, arms, legs, feet, and torso,
• Patients admitted to the burn centre,
• Patients with inhalation burns,
• Patients who receive sedation during dressing changes,
• Patients with complications such as infection or bleeding in the burn area,
• Patients who use pharmacological or non-pharmacological methods that may affect pain during dressing changes.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Control (Standard Treatment) Group

Experimental group

Description:

The standard dressing procedure in the control group is as follows: The protective covering over the wound is removed, and the wound is washed with an irrigation solution. Appropriate medications (decontamination and moisturising gel, debridement gel, alginate, antibiotics, and medications that promote cell regeneration) are applied based on the condition of the wound. A non-adhesive wound care dressing is then placed over the wound, and gauze is applied on top to cover it. Analgesia is not routinely administered in standard wound care. The dressing procedure takes an average of 5 minutes, depending on the size of the burn wound. In the control group, before the dressing procedure, the patient who volunteered to participate in the study will be given a patient information form, a burn-specific pain anxiety scale, and the pain level before dressing will be recorded using the Visual Analogue Scale (VAS) and vital signs will be checked, after which the standard dressing procedure will be

Treatment:

Other: Control (Standard Treatment) Group

Breathing Exercise Group

Experimental group

Description:

Before the dressing procedure, patients who volunteer to participate in the study will be given a patient information form, a burn-specific pain anxiety scale, and their pain level before dressing will be recorded using the GAS. After their vital signs are checked, they will be given a practical demonstration of breathing exercises. The breathing exercise will first be explained verbally by the project coordinator in the burn centre's training room, followed by a practical demonstration. The patient will then be asked to perform the exercise. Once the project coordinator is confident that the patient has learned how to perform the breathing exercise, the patient will be taken to the dressing room. During the standard dressing procedure, the patient will be instructed to continue performing the breathing exercise. Immediately before the dressing change, the patient will be positioned comfortably, and they will be instructed to use the breathing exerci

Treatment:

Other: Breathing Exercise Group

Stress Ball Group

Experimental group

Description:

The stress ball is made of a medium-hard plastic material that can be easily held in the hand. Before the dressing procedure, patients who volunteer to participate in the study will be given information about the use of the stress ball after the patient information form, the burn-specific pain and anxiety scale, and the pain level before dressing have been recorded using the GAS, and their vital signs have been checked. During the standard dressing procedure, patients will be instructed to squeeze and release the stress ball periodically until the dressing procedure is complete, focusing solely on the stress ball during this time (Ozen et al., 2023) (Kasar et al., 2020). A separate stress ball will be used for each patient in the stress ball group to ensure that the effectiveness of the stress ball remains consistent. To support patients' relaxation during the dressing procedure, a stress ball usage guide prepared by the project team will be provided via tablet. The

Treatment:

Other: Stress Ball Group