Real-time procedure information sharing as a means to reduce perioperative anxiety in families of children undergoing elective surgery - a randomized controlled study

Ethical declaration

This study adhered to the provisions of the World Medical Association’s Declaration of Helsinki and the National Health and Family Planning Commission of the People’s Republic of China’s “Regulations on Ethical Review of Biomedical Research Involving Humans” during the research process. It has been approved by the Ethics Committee of West China Hospital of Sichuan University (approval number: 2022 − 389), April 29, 2022), and has been registered in the China Clinical Trial Center (registration number: ChiCTR2300074573, October 8, 2023), (http://www.chictr.org.cn)” May 4, 2022, the first group of patients was enrolled, and on August 10, 2023, the trial was retrospectively registered.” All subjects and their relatives were informed about this study and signed an informed consent form before surgery.

Study design and sample

This study is a randomized controlled trial. Prior to this, we conducted a survey to determine the needs and opinions of the families of children undergoing surgery. The study will be conducted from May 2022 to October 2022 in the pediatric surgical ward of West China Hospital, Sichuan University, China. The participants’ general information will be randomly assigned by the researchers into two groups.

We did a pre-study survey, and it was conducted to assess parents’ demands regarding information sharing system and also to calculate sample size for the study. Based on the results of the pre-study survey, the current demand rate for information sharing during the perioperative period is approximately 79%. Assuming this demand rate will be achieved in this study, with a permissible error (Δ) of 5%, the estimated sample size is calculated as follows:

$$N=\right)}^\times P\left(1-P\right)$$

The total sample size was 92, with 46 in the intervention group and 46 in the control group.

Inclusion criteria include children aged 0–12 undergoing elective surgery, voluntary participation in the study and acceptance of randomization, anticipated surgery time < 2 h, postoperative transfer to the Post Anesthesia Care Unit (PACU), and families of children with at least a primary school education level. Exclusion criteria included patients with a history of prior surgery, postoperative transfer to the intensive care unit (ICU) for further treatment, patients and their families with a history of psychiatric illness, the inability of the patient’s family to correctly use communication devices for receiving real-time process updates, the inability of the patient’s family to cooperate or having language barriers, and a history of psychiatric illness or hypertension in the child or their family.

Randomization

The randomization in this study was to use a computer-generated random number. 50% of the numbers were odd numbers and the rest were even numbers. Then they were sorted by numerical order. The odd numbers were matched with control group, and the even numbers were matched with intervention group. There were 92 patients been examined, and finally, 3 of control group were and 2 of intervention group were excluded.

Data collection methods

Data collection was conducted using general information forms, the PSQI, the SOC-13, the SAS anxiety scale, and satisfaction ratings. The reliability and validity of these forms (Chinese Ver.) were proved to be available [11,12,13]. Prior to the surgery, training on the use of the push notification system was provided to the family members. Group testing and detailed observation records were carried out by the researchers one day before the surgery.

General information form

Researchers created a basic information form consisting of eight questions tailored to capture relevant data such as the child’s age, gender, duration of surgery, age of the family member, relationship with the child, education level, annual income, and marital status.

Pittsburgh sleep quality index (PSQI)

PSQI was developed by Dr. Buysse, a psychiatrist at the University of Pittsburgh, and others in 1989 [14]. Liu Zhixi analyzed this scale [15], and the overall Cronbach’s α coefficient for the Chinese population was 0.87. The scale consists of 19 self-assessment items and 5 other scoring items, of which 18 self-assessment items are scored in 7 dimensions: sleep time, sleep duration, sleep efficiency, sleep disorders, and subjective sleep quality. Each dimension is scored from 0 to 3, and the cumulative score of each dimension is the total PSQI score (0 ∼ 21 points). The higher the total PSQI score is, the worse the sleep quality [16].

State of cohesion-13 scale (SOC-13)

It is extracted from Antonovsky’s 29-item Sense of Coherence Scale [17]. The scale has 13 items, with a scoring standard of 1 ∼ 7 points, where 1 point represents “strongly disagree” and 7 points represent “strongly agree”. The total score of the scale is the sum of the raw scores of each item. The final score range is 13–91 points. A higher score indicates that the subject perceives a stronger sense of psychological coherence, and a lower score indicates the opposite. Bao Leiping’s analysis results show that the Cronbach’s α value of the SOC-13 scale in China is 0.76 [18].

Self-rating anxiety scale (SAS) [16]

SAS was developed by William W.K. Zung. It is a standard for anxiety assessment used to measure the severity of anxiety and its changes during treatment. The SAS contains 20 items, with the main statistical indicator being the total score. The raw score is obtained by adding the scores of the 20 items; the standard score is obtained by multiplying the raw score by 1.25 and rounding to the nearest whole number. According to the Chinese norm results, the cutoff value for the SAS standard score is 50 points, with 50 ∼ 59 points indicating mild anxiety, 60 ∼ 69 points indicating moderate anxiety, and 70 points and above indicating severe anxiety. The Cronbach’s α coefficient of the SAS scale in China is 0.777 [19].

Satisfaction score

This score includes a question about the satisfaction of the patient’s family with the text message reminder received after the surgery. “0” is defined as “completely dissatisfied”, and “100” is defined as “very satisfied”.

Unawareness

The relevant researchers need to understand the grouping and data situation of all patients and send part of the research data to the families of the patients. Due to the nature of the research intervention, the families of the patients and the researchers cannot ignore the intervention (information sharing) because they need to participate openly.

Data collection

Eighty-seven patients who met the inclusion criteria were prospectively identified. The researchers provided information, purpose, and significance about the study. On the day of surgery, basic data were collected using a general information form. The SAS scale was used to assess the anxiety of the families of the patients at six time points as follows: T0: one day before surgery; T1: when the patient was taken from the ward to the waiting area for patients, a nurse would scan the code on wristband and this time can be called as “waiting outside the operating room”; T2: as soon as the patient was taken into the operating room, the anesthetist will click the “entering room” option in the computer, and this time can be called as “entering the operating room”; T3: when the first time of surgeons cutting the skin, the anesthetist will click the “surgery start” option in the computer, and this time can be called as “the start of surgery”; T4: as soon as the end of suturing the skin the anesthetist will click the “surgery end” option in the computer, and this time can be called as “the end of surgery”; T5: when patient stayed in the PACU for at least 30 min, the nurse who was responsible for this patient would assess him/her if he/she could return to the ward, then the nurse will click the “leave the PACU” option in the computer if the assessment was passed, and this time can be called as “returning to the ward”. All of the information were exported from anesthesia system. The parents only received the time points above mentioned and the details on surgical steps will not be provided to them.

The SOC-13 score was used to assess the psychological state at T2, T3, and T5. The PSQI scale was used to assess the sleep quality of the families of the patients one day before surgery and the night of the day after surgery. The next morning, an anesthetist who was unaware of the grouping situation scored the patients would make the assessment. The satisfaction score was used to revisit perioperative satisfaction at the bedside one day after surgery.

Control group

The control group routinely underwent pre-anesthetic nursing visits and perioperative-related education (approximate surgical steps, required time, waiting location, etc.) one day before surgery. During the surgery, they relied on regular communication with doctors and nurses.

Experimental group

Unlike the control group, the experimental group shared real-time surgical progress information via a mobile application during the surgery. The specific plan is as follows: communicate with the families of the patients again one day before surgery and explain the specific process and risks of the surgery, agreeing to participate and share progress during the surgery. Ensure that the families understand the purpose of the surgery, communicate with them about each stage of the surgery, explain the details of the surgery, provide important information about the use of drugs and equipment, and answer any questions they may have. Information sharing channels (QQ, WeChat, email) were established, and the real-time status of the patient’s surgery collected from the surgical anesthesia system at five time points (T1, T2, T3, T4, and T5) was uploaded to the platform for integration and push to the families’ mobile phones. At the same time, related perioperative health education was sent. The families of the push group can obtain real-time updates on the progress of the child’s surgery through the information-sharing channel.

Primary and secondary research endpoints

The main purpose of this study is to analyze in detail the degree of attention of the families to the surgical process of the patients during the perioperative period to provide a basis for future medical staff to manage the surgical process of the patients during the perioperative period and to formulate targeted measures. The perioperative experience of the patients and their families should be fully improved.

The secondary goal of this study is to alleviate the psychological burden of the families of the patients during the waiting period of the perioperative period, improve the hospital environment, and increase patient satisfaction.

Statistical analysis

Data analysis was performed using the Statistical Package for Social Sciences (SPSS) version 22.0. Categorical variables were represented by absolute frequency and relative frequency, and continuous variables were represented by mean and standard deviation, according to normal distribution or nonnormal distribution. The student’s t test was used to compare the level of anxiety variables (numerical variables) and the remaining quantitative variables between groups. The chi-square test was used to test the correlation between qualitative variables and group variables. When the result (anxiety) was considered an ordered qualitative variable, the Mann‒Whitney test was used to compare the results (anxiety) of the two groups. A significance level of 5% was considered.

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