Medical practice requires a high degree of trust between patients and medical staff due to the potential for invasive risks to patients (1,2). In addition, ethical behavior is imperative in surgical practice, and considerable delibera-tion has been presented as an important component of surgical practice (3). All of the essential qualities for surgeons, such as ethical behavior, medical expertise, well-honed clinical judgment, superior manual dexterity, courage, and self-confidence, are taught explicitly and by example in surgical training programs.

Traditionally, surgical procedures are performed in a closed space in collaboration with various specialized equipment and medical staff. These closed spaces and invasive techniques can cause significant stress to patients undergoing surgery.

Many surgeries are performed under general anesthesia in order to prevent the patient from becoming aware of unstable vital signs during the surgical process. Although complications due to the use of general anesthesia may occur, the emotional anxiety felt by the patient during surgery is reduced. Due to the development of surgical techniques, a greater number of surgeries are now being performed with far less invasive methods. Local anesthesia is a safer alternative to general anesthesia; it requires less time and reduces complications caused by general anesthesia. However, it allows for the possible disadvantage of intraoperative discomfort and anxiety caused by the clarity of consciousness.

The degree of patient tension or anxiety before surgery may affect the surgical outcome. Some studies have confirmed that patients and their families experience similar anxiety (4). Annisa et al. (5) reported that very high anxiety or tension appears in patients ahead of surgery, and in this case, family support can partially reduce the patient’s anxiety. They noted that implementation of preoperative education and psychosocial intervention should be addressed in order to achieve the expected perioperative patient outcomes.

To establish trust between patients and medical staff and to reduce patient and guardian anxiety before surgery, we have developed and implemented the “Next of Kin Observation of Surgery Intervention” (NoKOSI). A pilot study was conducted prior to the main study to determine whether this system reduces anxiety and its clinical significance.

1) Aims

The purpose of this study is as follows.

First, the actual observation rate of the participated NoKOSI was investigated to calculate the number of subjects required for this study, as previous studies on any types of “family guardian observation system” were insufficient.

Second, we investigated whether there was a difference in the anxiety scale scores of patients before surgery depending on whether the guardian’s observation of the surgery reduced the anxiety and whether there was a correlation between the preoperative anxiety score and the family guardian observation request scale.

Third, after investigating the pros and cons of this system, we collected data and information necessary for this study to be conducted on a larger scale.

2) Study population

This was a prospective, observational study. From May 2022 to August 2022, the patient-guardian group that underwent surgery for chronic venous disease (CVD) at our hospital was targeted (Fig. 1). After listening to a com-prehensive explanation of the “family guardian observation system,” those patients who understood the purpose of the study and gave informed consent were included as participants. This study was conducted in three stages. During the first stage, the patient and guardian discussed the study requirements, and the guardian autonomously made a decision regarding whether or not they wished to observe the surgery. The actual rate of attendance during surgery was noted. We also investigated the reasons behind why guardians declined to participate in the surgical observation. In the second stage, events that occurred between patients and their guardians during surgical observation were investigated.

Figure 1. STROBE flow of the study.

In the third stage, both patient and guardian opinions were gathered through a written questionnaire. The procedure was explained by the researcher who performed the surgery. Another researcher, who did not perform the surgery, then investigated the reasons behind not attending, the actual attendance rate, the events during the operation, and responses from the questionnaires. All data were collected and recorded in a blinded manner.

3) Process protocol

The patient and guardian were asked to report the degree of anxiety using the modified Amsterdam Preoperative Anxiety and Information Scale (mAPAIS) (6) on the morning of surgery, following an explanation of the surgical and local anesthetic procedure.

We modified the APAIS to fit our situation. This was necessary for two reasons; firstly, because all procedures would be performed under local anesthesia, not general anesthesia, and secondly, rather than simply measuring the level of anxiety, we needed to quantify the degree by which the procedural explanation given by medical staff was deemed sufficient, as well as quantify the desire for guardian presence during surgery. Therefore, items 1∼3 related to anesthesia in the original APAIS were excluded, and instead, items such as “whether the medical staff explanation of the surgical procedure was sufficient (Q1)” and “would you like to have a family guardian beside you during the surgery (Q5)” were newly added (Fig. 2).

Figure 2. (A) Amsterdam Preoperative Anxiety and Information Scale (APAIS), (B) modified APAIS in the present study.

Each of the five items was graded on a five-point Likert scale from a minimum of 1 point (not at all) to a maximum of 5 (extremely) points. The three items related to preoperative anxiety were psychologically related to surgery (e.g. I am worried and afraid of undergoing surgery) and physical (e.g. I have a dry mouth or dizziness). Depending on the condition, the higher the anxiety level, the higher the score. In addition, our mAPAIS consisted of questions about whether there is sufficient procedure-related explana-tion by the medical staff and the scale of demand for the necessity of family or guardian observation felt by the patient. If the patient and guardian decide not to attend after consulting each other, they were asked why they did not attend.

If the family or guardian decided to observe, he or she listened to precautions for hand cleansing and infection prevention. After the patient was ready for surgery, the family or guardian entered the operating room. During the entire operation process, the guardian sat in a chair set beside the patient’s head to observe the entire procedure and was able to talk with the patient or ask questions to the medical team. The operating surgeon frequently explained the surgical process to the patient and guardian. Following completion of the surgery, the guardian left the operating room, and the surgical wound was disinfected and treated by the medical staff. At this time, medical staff who did not participate in the surgery measured and recorded the procedure-related pain score using the VAS scale (0∼10).

All surgeries were performed under local anesthesia, and no drugs related to changes in consciousness were administered in any case. Immediately after the operation, the patient was encouraged to walk, and was asked to write down their impressions on the NoKOSI system.

4) Statistical analysis

The primary outcome of this study was expressed as the percentage of attendance rate. The observing group was defined as Group O, and the non-observing group was defined as Group NO. Continuous data was expressed as the mean and standard deviation when data was parametric, and, the median and interquartile range when data was non-parametric. The non-parametric Mann–Whitney U test was performed to compare the averages of the anxiety scale and surgical pain between the preoperative and no-visit groups.

1) Attendance rate and the reasons behind declined participation

A total of 133 patient-family guardian pairs were enrolled in the study Of the patients, 88 (66%) were female and 45 (34%) were male. Of the 133 surgeries, 44 couples (33%) were Group O who voluntarily participated in the NoKOSI. There was no statistical difference in the participation rate between female and male patients (30/88, 34.1% in female vs. 14/45, 31.1% in male; p=0.88).

Reasons for declined participation in the remaining 89 couples (Group NO, 67%) were: lack of time (33%), a stressful burden on guardians (21%), unnecessary as it was judged to be a simple surgery (19%), unnecessary because they trusted the medical system (19%), and finally the patient would feel burdened by the presence of the family or guardian (8%) (Fig. 3A). There was no difference between the two groups in age, sex, comorbidity, CIVIQ-14 score, VCSS, patient-reported symptom severity (0∼5), and surgical method (Table 1).

Table 1 . Demographic and treatment characteristics between O and NO group.

	Total, n=133 (%)	Group O, n=44 (%)	Group NO, n=89 (%)	p
Age (mean±SD)	52.25±13.82	53.86±14.74	51.45±13.35	0.362
Gender (female)	88 (66.17%)	30 (68.18%)	58 (65.17%)	0.88
Comorbidity*	42 (31.58%)	15 (34.09%)	27 (30.34%)	0.81
Recurrence	4 (3.01%)	1 (2.27%)	3 (3.37%)	>0.99
CVD complication†	35 (26.32%)	9 (20.45%)	26 (29.21%)	0.384
CEAP class
0	22 (16.54%)	12 (27.27%)	10 (11.24%)	0.036
1	21 (15.79%)	4 (9.09%)	17 (19.10%)	0.216
2	58 (43.61%)	17 (38.64%)	41 (46.07%)	0.531
3	11 (8.27%)	4 (9.09%)	7 (7.87%)	>0.99
4	18 (13.53%)	6 (13.64%)	12 (13.48%)	>0.99
5	2 (1.50%)	1 (2.27%)	1 (1.12%)	>0.99
6	1 (0.75%)	0 (0.00%)	1 (1.12%)	>0.99
CIVIQ-14 (median, IQR)	20.5 (17∼26)	23 (18∼31)	20 (17∼25)	0.106‡
VCSS (median, IQR)	3 (3∼5)	3.5 (2∼5)	3 (3∼5)	0.94‡
Symptom severity 0∼5 (median, IQR)	3 (2∼4)	3.0 (2∼5)	3 (2∼4)	0.105‡
Main procedure
Endovenous laser ablation	65 (48.87%)	20 (45.45%)	45 (50.56%)	0.462
Radiofrequency ablation	36 (27.07%)	15 (34.09%)	21 (23.6%)	0.283
Cyanoacrylate glue	24 (18.05%)	7 (15.91%)	17 (19.1%)	0.833
Primary phlebectomy	8 (6.02%)	2 (4.55%)	6 (6.74%)	>0.99
Concomitant phlebectomy	54 (40.6%)	17 (38.64%)	37 (41.57%)	0.891

*Hypertension, diabetes, hyperlipidemia, thyroid disease, peripheral arterial occlusive disease (PAOD), deep vein thrombosis (DVT), lymphedema..

^†Bleeding, thrombosis, pigmentation, lipodermatosclerosis, static ulcer, painkiller medication, deep vein thrombosis, eczema..

^‡Nonparameteric Mann-Whitney U test..

CVD: chronic venous disease, CIVIQ-14: chronic venous insufficiency quality of life questionnaire score, VCSS: venous reflux-originated severity score..

Figure 3. (A) Patient-Family or guar-dian’s reasons for not participating in the Family Guardian Observa-tion System during the Operation (NoKOSI) trial. (B) Patient-Family or guardian’s positive and negative responses to the NoKOSI experience.

2) Preoperative mAPAIS, operative VAS pain scale, and NoKOSI attendance rate

The mAPAIS reported before surgery was significantly higher in Group O than in Group NO (13.2±3.3 vs. 11.1±3.6, p=0.014). However, there was no difference between the two groups in the intraoperative pain scale (4.28±2.5 vs. 3.59±1.9, p=ns), and there was no significant correlation between the preoperative mAPAIS and the operative VAS pain scale in all patients (r=0.013, p=ns). The preoperative anxiety score was significantly correlated with the Family Guardian Observation Request Scale (r= 0.474, p=0) (Fig. 4).

Figure 4. Comparison of preoperative modified Amsterdam Preoperative Anxiety and Information Scale (A), and perioperative VAS pain scale (B) between Group O and Group NO. Correlation between the preoperative anxiety score and the family guardian observation request scale (C).

3) Patient and family or guardian responses to the NoKOSI experience

After participation in the NoKOSI (44 pairs, 88 people), 11 patients (25%) and 44 guardians (100%) wrote their impressions on the questionnaire. The 44 guardians submitted 49 comments. Of the 11 patients who reported their impressions, 10 patients gave positive opinions, and one patient gave a negative opinion. Of the 49 guardian’s opinions, 38 (77.6%) were positive and 11 (22.4%) were negative (Fig. 3B). The positive opinions submitted by the patient included psychological stability and anxiety relief during the surgery, and the negative opinion was due to concerns that the observing family or guardian member would have psychological anxiety. The positive comments submitted by the family or guardians noted the increase in trust in the medical staff and institutions, and the relief of anxiety. Negative opinions included dissatisfaction with the observation environment, tension and fear during surgery, and dissatisfaction with the hospital facilities.

4) Complications of NoKOSI

Complications occurred during the observation system in three cases. In two cases, the guardian experienced dizziness and nausea due to fear and stopped the observation, and in the last case, there was an episode of fainting.

In recent decades, the medical environment has developed the capability to provide greater care for patients than ever before. Unfortunately, trusting relationships between patients and medical staff are often not as strong as they once were (7). In some cases, medicine has become a business, guided by the financial constraints rather than by an uncompromising concern for the patient. Within this fast-paced corporate system, surgeons charge too much and pushed to perform too many operations. These factors adversely affect the relationship between patients and their medical team (7). This often causes patients making decisions on their care without professional medical knowledge, and results in patients undergoing surgery in a distrustful environment. This can adversely affect the surgical outcome, therefore establishing trust between patients and their doctors is essential.

Surgical patients experience some degree of psycho-logical distress in the preoperative period (8). Regardless of complexity, if the surgery is invasive, then anticipated pain and separation from the family are core factors that trigger symptoms of perioperative anxiety (9). Such anxiety may affect the surgical outcome. The nature of local anesthetic operations, in which the patient is conscious yet emotionally isolated from the others in the room, leads the patient to experience a certain physical rigidity that lasts the duration of the operation. Yilmaz et al. (10) demonstrated that preo-perative anxiety in patients awaiting surgery was associated with demographic characteristics as well as social support resources. Therefore, such anxiety extends to the family members, and not only the patient in question.

We devised the NoKOSI system so that patients could undergo surgery in a less anxiety-inducing perioperative environment. This pilot study was conducted to identify the following new facts.

First, 33% of the approached patient-family or guardian pairs agreed to participate in the NoKOSI system. This was somewhat lower than the authors’ predictions, but the busy daily schedules of the family guardians in modern society were a factor in not being able to participate in the NoKOSI system (33%). In addition, most of the respondents did not feel the need for such a system as they already had established trust in the medical staff. Based on these facts, we infer that the reliability of medical staff and institutions in the community contributes to a certain extent in reducing the need for the NoKOSI system.

Second, there was no difference in attendance rates between male and female patients (female 34% vs. male 31%). These data indicate that there is no difference between men and women in the need for NoKOSI based on perioperative anxiety.

Third, the preoperative mAPAIS score was significantly higher in Group O, suggesting that it is necessary to actively encourage family or guardians to participate in the NoKOSI for patients with high preoperative anxiety scores.

Fourth, 80% of the responses showed a positive review of this system, supporting the idea that NoKOSI is necessary for some patients and their guardians.

The negative aspects of the NoKOSI should also be noted. In particular, it is judged that medical staff should give sufficient emotional and environmental consideration to the anxiety felt by guardians when implementing this system. Lastly, we need to fully prepare for complications that may occur during actual observation.

In varicose vein surgery performed under local anesthesia, 33% of the family or guardians partook in the NoKOSI trial. It might be a useful system for some patients, especially those with high preoperative anxiety, and may result in a positive effect. When implementing the system, attention should be paid to the safety of the patients and their family or guardians. The necessity and efficacy of the family or guardian observation system during surgery should be investigated in larger prospective studies.