This clinical trial (IR.ZBMU.REC.1397.037) aimed at determining the effect of regular smooth breathing on the pain associated with dressing in patients with second-degree burns who had referred to Imam Hossein Burn and Rehabilitation Center of Zabol, Southeast Iran, between June and October 2018. The eligibility criteria included informed consent to participate in the study, 15 - 45 years of age, no addiction, lack of mental illnesses or specific underlying diseases such as diabetes, cancer, and thyroid disease, burn injuries between 5% and 45%, having second-degree burns, no burns in the abdomen and chest, having at least one dressing experience since the burn injury, and respiratory stability. Failure to perform the respiratory procedure when dressing was a criterion to disqualify the patients.
The sample size was estimated at 10 for each group using the following formula (
20):
The above formula was solved based on the study by Bozorg-Nejad et al. (
16), the mean pain score in the experimental and control groups, the 95% confidence interval, and the 80% power. Concerning the possibility of attrition, this size was increased to 15 for each group (30 in total).
A demographic questionnaire (including age, gender, type of burn, and burn percentage) was used to collect general data, and a visual analog scale (VAS) was employed to assess the intensity of pain. This scale included a 10-cm horizontal line. The validity and reliability of this tool have been confirmed in several studies (
15,
16,
21).
In order to observe the ethical considerations, after explaining the goals of research to the patients, the researcher asked them to show their willingness to participate in the study by signing the consent form. The method of regular smooth breathing was taught by the researcher when the patient was at rest and under no stress. An audio file describing the procedure of the respiratory intervention was played for the patients so that they could coordinate their breathing with it. After performing the respiratory exercises and ensuring the acquisition of the required skills, eligible patients entered the study. In this method, the patient inhaled through the nose on a count of 4, paused on a count of 4, and exhaled on a count of 4 with the lips pursed. This is the modified version of the 4-7-8 technique or “relaxation breathing” (
22).
The intensity of pain was measured after dressing. The dressing process took 30 minutes on average. The respiratory intervention began after painkiller injection and before dressing, and it continued until the dressing process finished. The experimental group did the respiratory exercises at least 20 times before dressing was over.
The control group, however, was provided only with the routine care, which included the intravenous administration of morphine (based on patient’s weight) about 5 min before dressing. This was carried out for patients of both groups.
After dressing, the pain score was calculated again in both groups. The intervention continued up to four consecutive sessions of dressing change. The related data were collected after each session. The obtained data were analyzed in SPSS 23 using the chi-square test, Fisher-exact test, and independent t-test. The significance level was set at < 0.05.