The study was a single blind, randomized, controlled trial.Researchers recruited subjects from one Central South University-affiliated general tertiary hospital in Changsha, Hunan province, China. And the whole trail was on the basis of the CONSORT statements.Study procedures were approved by the institutional review boards of all participating centers before data collection began. All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if the provided consent.
According to the statistics of the operation center, the main types of operations performed on children are adenoidectomy, tonsillectomy and pediatric occult penile surgery. The literature shows that the age of children undergoing tonsillectomy and adenoidectomy is concentrated in 4-12 years old, and the children with hidden penis surgery are concentrated in 3-12 years old. Therefore, the age for the patients were from 3 to 12 years.Researchers explained the study purposes,procedures, benefits, and risks involved orally to children's parents and participants were recruited with their parents' informed consent.
According to the sequence of the children entering the study, each group(animation group, music group and control group) of 3 persons was randomly divided into 3 subjects in each block according to the random number table. The blind copy shall be kept by the personnel of the unit who have nothing to do with the experiment. The randomization plan will be saved by the statistician, and the researcher only has the number of each subject. After opening the envelope according to the number, the researcher knew whether the subject is the control group or the intervention group. Investigators involved in the intervention were not involved in the analysis of the study data.
In the music group, on the basis of the routine preoperative care, the preferred music was selected from the music library as the intervention content on the day of surgery according to the preference of the children in the 1-day preoperative visit. If there was no preference, the music was played randomly. During the intervention, the same multimedia audio system (Wanderer EDIFIER R1700BT) was used to play music for 30-40 minutes, the volume was controlled at 35-80dB, and adjusted in time according to the feedback of the children.The children in animation group also chose their favorite cartoons as the intervention content on the basis of preoperative care. The same pad (Lenovo TB3-850F) was used to play pre-selected cartoons, and volume as the music group. During the intervention period, the children in intervention group were also accompanied by a nurse, who was also responsible for the implementation and maintenance of the intervention program.
In the control group, the children were received the routine care. One day before the operation, nurses from operating room conducted routine preoperative visits, they communicated effectively with the children and their families, and conducted psychological counseling. The visit time lasted nearly 30 minutes. On the day of surgery, all children were admitted to a special waiting room for children 0.5 h in advance, and venipuncture was performed by a circuit nurse. Colorful cartoon patterns were depicted on the walls of the waiting room, and various toys for children were placed indoors. After entering the operating room, the child was accompanied by a parent in the waiting room for the child to wait for surgery. During the period, a nurse in the research group gave routine psychological comfort, preoperative guidance, answered questions about anesthesia and surgery raised by the children and their parents. Before anesthesia induction, the child was brought into the operating room for anesthesia induction and surgery by operating room nurse, anesthesiologist, and surgeon, while the child's parents leave the waiting room and wait outside the operating room.
The researchers assessed the children's anxiety status, the degree of cooperation during the induction of anesthesia, and recorded the heart rate and blood pressure of the children at three moments: before entering the operating room (baselineT0), entering the operating room(T1), and before induction of anesthesia(T2).Before data collection, researchers who conducting data collection should be trained in measurement tools and assessment methods. The training contents mainly include: (1) explaining the purpose, meaning and the scoring method of the measurement tools; (2) Scoring the child's anxiety through pictures at three time points, discussing the reasons for consistent or inconsistent results, and repeating until the coefficient of agreement κ≥0.8.
