Use of Breathing Exercises and Stress Balls During Dressing Changes in Burn Patients
NCT ID: NCT07100041
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2025-08-04
2025-12-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control (Standard Treatment) Group
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
Control (Standard Treatment) Group
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,
Breathing Exercise Group
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
Breathing Exercise Group
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
Stress Ball Group
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
Stress Ball Group
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
Interventions
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Breathing Exercise Group
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
Stress Ball Group
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
Control (Standard Treatment) Group
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,
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Hasan Kalyoncu University
OTHER
Responsible Party
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Senem Andı
Master of Science in Nursing
Locations
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Ministry of Health Adana City Training and Research Hospital Burn Centre
Adana, , Turkey (Türkiye)
Countries
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References
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Sarıtaş, S. Ç., Çevik, S., & Özden, G. (2018). Genel Konfor Ölçeği Kısa Formunun Türkçe Geçerlik ve Güvenirlik Çalışlması. Diyabet, Obezite ve Hipertansiyonda Hemflirelik Forumu Dergisi, 10(2), 16-22.
Kolcaba K, Tilton C, Drouin C. Comfort Theory: a unifying framework to enhance the practice environment. J Nurs Adm. 2006 Nov;36(11):538-44. doi: 10.1097/00005110-200611000-00010.
Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.
Aktas GK, Ilgin VE. The Effect of Deep Breathing Exercise and 4-7-8 Breathing Techniques Applied to Patients After Bariatric Surgery on Anxiety and Quality of Life. Obes Surg. 2023 Mar;33(3):920-929. doi: 10.1007/s11695-022-06405-1. Epub 2022 Dec 8.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Fatma Eti Aslan. (2004). Sensitivity and selectivity of visual analog scale and the verbal rating scale in the assessment of postoperative pain. J. Intensive Care Nurs., 8, 1-6.
4. Bozorgnejad, M., Zarei, M. R., Mamashli, L., & Mohaddes Ardebili, F. (2019). The Effect of Rhythmic Breathing on the Anxiety of Dressing Change in Burning Patients. International Electronic Journal of Medicine, 8(2), 95-100. https://doi.org/10.34172/iejm.2019.04
Najafi Ghezeljeh T, Mohades Ardebili F, Rafii F. The effects of massage and music on pain, anxiety and relaxation in burn patients: Randomized controlled clinical trial. Burns. 2017 Aug;43(5):1034-1043. doi: 10.1016/j.burns.2017.01.011. Epub 2017 Feb 4.
7. Erbay, Ö., Yıldırım, Y., Fadıloğlu, Ç., & Şenuzun Aykar, F. (2019). Use of the Kolcaba's Comfort Theory in the Nursing Management of a Case with a Colostomy Opened Due to Rectum Cancer. Journal of Traditional Medical Complementary Therapies, 2(1), 42-48. https://doi.org/10.5336/jtracom.2019-64998
Lee HW, Ang L, Kim JT, Lee MS. Aromatherapy for Symptom Relief in Patients with Burn: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2021 Dec 21;58(1):1. doi: 10.3390/medicina58010001.
Other Identifiers
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HKU-SBF-SA-02
Identifier Type: -
Identifier Source: org_study_id