Iran Journal of Nursing

1. Introduction
Congenital Heart Defects (CHD) prevalence is about 6-8 per 1000 live births, more than half of which will require surgery during the first year of life. In Iran, the rate of diagnosis of cardiovascular diseases is increasing, so the mortality caused by them in the intervals from 1989 to 2006 has increased from 27%-30%. CHD accounts for almost one-third of all congenital anomalies. Today, CHD has become one of the health-threatening problems and one of the physically debilitating factors for children in Iran and is considered one of the leading causes of death in the first year of life. 
Surgical procedures, like any other treatment, have side effects. One of the significant complications following surgery is pressure ulcers. This complication is caused by the patient being in a relatively stable position. Health care providers perform to access the surgical site, control the patient’s respiratory status, access the peripheral vein, and monitor devices. Static and dynamic mattresses have been used in medical centers to reduce pressure to prevent pressure ulcers. In this study, an attempt was made to use a dynamic bed designed to fit the size and weight of infants and children undergoing open-heart surgery.
2. Materials and Methods
This study was a randomized clinical trial. The participants of this study were 135 children undergoing open-heart surgery with ages of 0 to 12 years referred to two heart centers in Tabriz and Tehran cities. They were included in the study by continuous sampling for one year (September 2016- September 2017). The participants were randomly assigned to two groups, experimental and control. 
The intervention groups used air cushions with an air inlet and an outlet pump filled and emptied by a pump to create 3-4 cm waves. With dimensions of 40 by 30 cm waterproof and anti-allergy air cushion, this air cushion is covered with a cotton cover with a patent with international classification in Iran (A61G 7/00; A47C 27/08). In the control group, based on the routine care of each hospital, a protective gel was used under the head. Assessment for each sample included the following steps: 1) before the operation, 2) after the operation (inside the operating room), 3) the first day after the operation, 4) the second day after the operation (stages 3 and 4 the child’s head was assessed in the intensive care unit).
In this study, data collection tools include 1) the National Pressure Ulcer Advisory Panel (NPUAP) checklist to assess the skin’s condition on pressure ulcer occurrence. The completed index and the wound were evaluated and recorded in 4 steps. 2) The Braden Q Scale was modified and developed based on the Braden Scale by Curley et al. for predicting pediatric pressure ulcers, especially in PICUs. This scale has been used in the population of children under 6 years of age in PICUs. This scale reflects the needs of the child’s patient, and it has 7 subsets, including sensory perception, moisture, activity, mobility, nutrition, friction, and oxygenation. Oxygenation has been added to the Braden Scale for infants. 
The score range of this questionnaire is between 7 to 28; low scores indicate high risk, and high scores indicate low risk. Scores 22-28 indicate low risk, 17-21 indicate moderate risk, and 16 and less, the risk is high. In the present study, the reliability of the Braden Q scales was confirmed using internal consistency. Cronbach’s alpha coefficient was 0.78 for the Braden Q scale. Also, the correlation coefficient in 20 samples in simultaneous observation between the researcher and two different nurses was more than r=0.70. 
Ten faculty member nurses and surgeons assessed the Braden Q’s face validity and content validity. The data were analyzed using SPSS software v. 20, descriptive statistics (Mean±SD), and inferential statistics (Chi-square, independent and paired t-test, Fisher’s exact test, Mann-Whitney, and ANCOVA). 
3. Results
A total of 135 children were included in the study, including 69 children in the intervention group and 66 children in the control group. In the control group, 4 children were excluded from the study. This study showed that more than half of the children participating in this study were girls in the intervention and control groups. More than 85% of mothers and more than 65% of fathers had a diploma in the two groups of intervention and control groups. Most fathers had jobs, and mothers were housewives. In the intervention group, the most common disease was Transposition of the Great Arteries (22%), and in the control group, Tetralogy of Fallot (33.9 %). The study showed that the control and intervention groups were homogeneous in demographic and clinical characteristics. 
The Incidence of postoperative pressure ulcers in the control group was 38.7%, on the first day after surgery, 71%, and on the second day after the surgery, it reached 67.7%. Cochran’s test showed that the Incidence of pressure ulcers did not differ significantly over time in the control group. While in the intervention group, none of the participants in all postoperative periods, from the first day to the second day after surgery, observed occipital pressure ulcers.
The numerical index of predictive dimensions of pressure ulcers in the control and intervention groups showed a significant difference in sensory perception before surgery between the two groups (P=0.004). By controlling the confounding effect, the ANCOVA results showed a significant difference between the two groups in the periods after the surgery until the second day of surgery (P<0.05). 
Sensory perception during the times after the surgery and the first day of surgery in the intervention group was significantly lower than in the control group, while the opposite was observed on the second day of surgery. There was a significant difference between the two groups regarding activity after surgery and the second day of surgery (P<0.05). Training on the day after surgery in the intervention group was significantly lower than in the control group and was the opposite on the second day of surgery. There was a significant difference in mobility before surgery between the two groups (P=0.001). However, the ANCOVA results showed a significant difference in mobility between the two groups only after the intervention (P=0.02). The mobility in the intervention group was significantly lower than in the control group. There was a significant difference in moisture before surgery between the two groups (P=0.022).
The ANCOVA results showed The moisture score in the intervention group was significantly higher than the control group. In terms of friction, there was no significant difference between the intervention and control groups in any of the studied times (P<0.05). There was a significant difference between the two groups regarding nutrition before surgery (P=0.003). The ANCOVA results showed a significant difference between the two groups during the first day of surgery (P=0.02). Food in the intervention group was significantly lower than in the control group. Also, there was no significant difference between oxygenation before and after the surgery. The results showed that the difference between the two groups was significant in terms of oxygenation (P<0.05). Oxygenation was significantly higher in the intervention group than in the control group. 
Furthermore, the results of the independent t-test showed that there was no significant difference between the scores of pressure ulcers in the preoperative times between the intervention and control groups (P<0.05), but after the surgery and the second day of surgery, the scores of pressure ulcers in the intervention group were significantly more than the control group (P=0.002). This means that the pressure ulcer scores in the intervention group were better than the control group at the desired times. 
4. Conclusion
The results showed that using air cushions appropriate to the size and weight of infants and children is suitable equipment to prevent occipital pressure ulcers in children undergoing open-heart surgery compared to routine methods for placing the head during long-term surgery in two hospitals. Therefore, it is recommended that air cushions appropriate to the age and size of children be used to prevent pressure ulcers in the back of the head and the consequences of this complication in children undergoing extended operations, including open-heart surgery.

Ethical Considerations
Compliance with ethical guidelines
This article is the result of a master's thesis at Iran University of Medical Sciences. The code of ethics was received from the ethics committee of Iran University of Medical Sciences (IR.IUMS.REC.1397.373) and presented to two universities of medical sciences and health services of Tabriz and Iran (Code: IRCT20190630044056N1).

Funding
The project is sponsored by Iran University of Medical Sciences and Health Services.

Authors' contributions
Conceptualization: Azita Matinpour and Sedigheh Khanjari; Research: Azita Matinpour, Mohammad Mahdavi and Shahriar Anvari; Analysis: Hamid Haqqani; Project Management: Sedigheh Khanjari; Editing and finalizing: Sadifeh Khanjari.

Conflict of interest
The authors declared no conflict of interest.

Acknowledgments
Among the professors of the School of Nursing and Midwifery of Iran University of Medical Sciences, postgraduate nursing students, officials of Shahid Rajaei Cardiovascular Research Hospital and Shahid Madani Cardiovascular Research Hospital of Tabriz, Tavan Hamgam Company who were in charge of making air cushions and All the people and patients who helped us in this research are appreciated.


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