This randomized clinical trial (RCT) by a pretest-posttest design with intervention and control groups was carried out from July 2016 to April 2018. This study was conducted in a burn department of an educational hospital in Kermanshah, west of Iran. The inclusion criteria were the age range of 18 - 80 years, the severity of the burn greater than 15% (grades II and III), being oriented to time, place, and person, having the ability to respond to the study questionnaires and communicate with the nurse, and no history of burn injuries. The exclusion criteria were survivors’ death or migration to other cities during the study process, no response to the nurse’s phone calls during the follow-ups, and a drop out of communication with the nurse researcher.
The sample size was defined based on the results of previous studies, including mean quality of life (
21) and the prevalence of mental health problems in burn survivors (
22). Then, based on the formula at a confidence level of 95%, a power of 80%, and d = 7 (
21), and with an attrition risk of 20%, 45 samples were determined for each group (total sample, n = 90). The eligible samples were recruited in the study during the hospital discharge based on the inclusion criteria and then were randomly divided into two groups. A randomized block design was used to ensure an equal distribution of samples into the two groups with different depths and severity of burns. A randomization list was created by PASS software (version 11) for random allocation. There were an intervention and a control group with block size 8, list length 90, and two strata (category A: burn severity within 15 - 25%; category B: > 25%; the percentage of burns was based on the Lund and Browder chart in the patient’s file). A randomization list for 90 samples was produced based on the burn percentage.
Figure 1 depicts the CONSORT flowchart of the most common reasons for the dropout of the samples. A blind approach was used, and the samples and burn clinic staff were unaware of the sample assignment to the intervention or control group.
CONSORT diagram of the study
A specific home care plan was developed for burn survivors in the intervention group. This plan was a dynamic and continuous care process that included mental health screening based on the General Health Questionnaire-28 (GHQ-28), education, and referral to specialists (psychologists and psychiatrists or psychiatric centers) and follow-ups. Follow-ups and psychological status reassessments were planned after referring the survivors to psychiatric centers. The survivors in the intervention group received a collection of information about ASD, PTSD, depression, pharmacological information, signs and symptoms that were clues for admission to a psychiatric center, education of family members, need for psychological consultations, need for emergency medical visits, and time and place that they can call to request home care visits. In cases of committing suicide, an emergency home visit and coordination for emergency hospitalization were performed.
The GHQ-28 was developed by Goldberg in 1978 to screen mental health disorders. It is a 4-point Likert scale questionnaire with 28 items and four dimensions, including somatic symptoms (items 1 - 7), psychological symptoms, anxiety and insomnia (items 8 - 14), social dysfunction (items 15 - 21), and depression (items 22 - 28). Scores for all dimensions of the questionnaire range from 0 to 21 with a total score of 0 - 84. The higher score represents poor mental health status. Cut-off point 23 is used to determine mental health issues. In addition, a score above 6 represents the disruption in related dimensions (
23-
25). In this study, the psychological health of survivors was measured by a valid and reliable Persian questionnaire. It was used together with a demographic information questionnaire. Concurrent validity and internal consistency reliability of the Persian version of the GHQ-28 were confirmed in previous studies (
24,
26). In the present study, the internal consistency reliability of the questionnaire was satisfactory (α = 0.81).
All burn survivors in both groups responded to the questionnaires at three time points, baseline (T1: hospital discharge) and 3 (T2), and six months (T3) after the intervention. In these three time points, the psychological status of survivors was assessed. The psychological needs of survivors were identified based on the GHQ-28 scores and a short interview with them. The survivors received home visits based on their needs and the severity of their psychological manifestations. Communication between the first author and survivors was maintained by telephone calls. Home visits were continued for six months.
3.1. Ethical Considerations
The project and the ethical issues of the study were approved by the Research Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran (ID: SBMU2.Rec.1394.168). All the survivors signed an informed consent form. They were informed of voluntary participation in the study and could withdraw whenever they wished.
3.2. Data Analysis
The data were analyzed by descriptive and inferential statistics using the chi-square test, independent t-test, repeated measures analysis of variance (ANOVA), and Tukey’s post-hoc test by SPSS software (version 20; SPSS Inc, Chicago, IL, USA). The normal distribution of the outcome variables was evaluated by the Kolmogorov-Smirnov test.