The effect of therapeutic listening on anxiety and fear among surgical patients: randomized controlled trial

ABSTRACT Objective: To investigate the effect of therapeutic listening on state anxiety and surgical fears in preoperative colorectal cancer patients. Method: A randomized controlled trial with 50 patients randomly allocated in the intervention group (therapeutic listening) (n = 25) or in the control group (n = 25). The study evaluated the changes in the variables state anxiety, surgical fears and physiological variables (salivary alpha-amylase, salivary cortisol, heart rate, respiratory rate and blood pressure). Results: In the comparison of the variables in the control and intervention groups in pre- and post-intervention, differences between the two periods for the variables cortisol (p=0.043), heart rate (p=0.034) and surgical fears (p=0.030) were found in the control group, which presented reduction in the values of these variables. Conclusion: There was no reduction in the levels of the variables state anxiety and surgical fears resulting from the therapeutic listening intervention, either through the physiological or psychological indicators. However, the contact with the researcher during data collection, without stimulus to reflect on the situation, may have generated the results of the control group. Clinical Trial Registration: NCT02455128.

is related to the need to increase knowledge and broaden discussions on the use of therapeutic listening as a way to reduce anxiety and surgical fear, which are present in patients who are expecting a surgical procedure. The objective of this study was to investigate the effect of therapeutic listening on state anxiety and surgical fears in preoperative patients of colorectal cancer surgery.
To do so, the variables compared in the pre and post intervention stages and in the control group (CG) and intervention group (IG) were physiological variables (salivary cortisol and amylase, heart and respiratory rates and blood pressure) and psychological variables (state anxiety scores and surgical fears) associated with feelings of anxiety and fear.

Method
This is a prospective, parallel, open-label randomized controlled trial with equal allocation rate (1:1).
The study participants were patients admitted for surgical treatment of colorectal cancer in the surgical clinic of a teaching hospital located in a city in the state of São Paulo (Brazil). For the calculation of the sample size, the State-Trait Anxiety Inventory (STAI) was used. Considering a difference of 10 points (δ) in the State-Trait Anxiety Inventory -Sate (STAI-S) score, a significance level of 5% (z 1-α = 1,96) and a power of 80% (z 1-β = 1.96), the result was 25 individuals for each group. The data related to the group variances was obtained by a procedure test, with correlation of 0.5.
Participants were eligible for inclusion if they: (a) were 18 years old or older, (b) were hospitalized for colorectal cancer surgery, (c) were not undergoing any other cancer treatment, (d) were not participating in another research (e) had a level of education that allowed reading and interpreting the instruments used in the study, which were self-reporting (f) were clinically well and/or stable (obtained score less than or equal to 3 in the Eastern Cooperative Oncology Group), and (g) presented a state anxiety score equal to or greater than 25 in the STAI-S in the first approach, which was performed previously and independently from the pre-intervention data collection. The cut-off point of 25 in the STAI-S was based on the findings of a study on the effects of complementary therapies on clinical outcomes in patients being treated with radiation therapy for prostate cancer (18) .
The exclusion criteria were: (a) having psychiatric disorders (identified in the patient's medical record), (b) presenting metastasis and (c) using medication containing corticosteroids.
The discontinuity criterion adopted for this study was related to patients who were receiving procedures necessary for the surgery during the data collection Garcia ACM, Simão-Miranda TP, Carvalho AMP, Elias PCL, Pereira MG, Carvalho EC. process, such as the preparation of the intestinal tract.
These patients were discontinued from the study.
In the IG, the patients were informed that they would have 30 minutes to talk to the researcher about their experience with hospitalization for cancer treatment (concerns, fears, doubts, or any other issue the patient wanted to treat). The interaction was initiated with the following guiding question: "How has your experience been in the hospitalization for the treatment of your disease?" Before the end of the therapeutic listening intervention, the patient was asked the following question: "Is there anything else you would like to talk about?" In the CG, patients were told they would have some data collected. Subsequently, the researcher would be absent for 30 minutes and, after this interval, would return for the conclusion of the research.
The data were collected from August 2014 to October 2015. Data collection schedules were previously set according to the hospital routine. Participants were admitted to a preoperative unit the morning of the day before surgery. Data collection occurred on the day of admission of the patients, who were invited to participate in the study after being informed about the purpose of the research.
The data collection occurred in three moments: first approach, pre-intervention moment and postintervention moment. In the first approach, carried out at 8a.m., when patients had already been assessed for eligibility according to the inclusion and exclusion criteria, the STAI and a questionnaire to characterize the participants were applied. After two and a half hours, in the second moment of the study (pre-intervention) the following data were collected: saliva samples for analysis of salivary cortisol and salivary alpha-amylase (SAA), heart rate (HR) and respiratory rate (RR), systolic blood pressure (SBP) and diastolic blood pressure (DBP), state anxiety, and surgical fears. One hour after the preintervention stage and shortly after the IG intervention and the CG, in the third and last moment of the study (post-intervention), the same variables were collected.
In order to verify the presence of circadian rhythm of cortisol in the participants, two samples of saliva were collected, one at 8p.m. and the other at 11p.m., on the day before the surgery. The objective of the verification of the circadian rhythm was to identify if the participants of this study, patients with cancer, would present differences in this rhythm.
Participants were randomized into two groups: control and intervention. For this, a person who was not part of the activities developed in this research generated a randomized list in Excel 2007, which contemplated the CG and the IG. The sheets containing the descriptions "Intervention Group" and "Control Group" were each placed in opaque envelopes, sealed and opened by the main researcher after the data collection in the pre-intervention moment, when it was decided on which group the patient would be allocated.
The instruments used in this study were answered by the patients themselves and the data referring to the physiological variables were collected by the researcher.
During the data collection period, two participants declined to participate and five were discontinued due to routine hospital care activities during data collection.
Thus, 50 participants reached the end of the study ( Figure 1).
The following instruments were used for data collection: Socio-demographic questionnaire: the sociodemographic variables collected were age, gender, level of education, marital status, monthly family income and religion; State-Trait Anxiety Inventory: the anxiety was evaluated through the STAI (19) , validated in Brazil (20) . "fear of the short-term consequences of surgery" (5 items) and "fears of the long-term consequences of surgery" (3 items). The score for each item ranges from 0 to 10. To calculate the overall score, the sum of the scores for each item should be divided by the number of items in the instrument. Thus, higher values are associated with higher levels of fear (21) . Regarding the SFQ reliability, considering the total scores of both groups at the pre-intervention time, the result was α = 0.77, a value considered acceptable for this study (22) .
Regarding the physiological variables, HR and SBP/ DBP were measured using the Omron® blood pressure and heart rate portable monitor (Japan). RR was identified by counting thoracic breathing movements for a period of 1 minute. Salivette ® (Sarstedt -Alemanha) swab in cotton was used to collect saliva for salivary cortisol identification. Samples were analyzed using the

Results
The mean age of the participants was 58 years in the IG (SD = 11) and 57 years in the CG (SD = 15).

Most of the participants had low level of education
(incomplete and complete primary education), were married, Catholic and had a monthly family income between one and three minimum wages (Table 1).   Table 2.
There were no significant differences between the groups after the intervention, so at that moment the groups were equivalent in relation to the studied variables. Thus, the therapeutic listening intervention did not cause differences between the two groups under the conditions in which it was applied to the participants (Table 3).  According to the results of Table 4, the changes between the pre-and post-intervention moments were not significant in the IG but were significant in the CG. In this group, before the intervention, the following means were obtained for salivary cortisol, HR and surgical

Discussion
In this study, we investigated the efficacy of therapeutic listening on state anxiety and surgical fears in preoperative colorectal cancer patients. Other nonpharmacological interventions have also been tested for their effectiveness in reducing anxiety in cancer patients and, in the circumstances in which they were performed, presented results that corroborate this study, since they also had no influence in reducing this feeling. A randomized controlled trial was conducted with the objective of testing the hypothesis that a multidisciplinary approach could improve understanding of the information provided by the anaesthesiologist and in turn, reduce anxiety in women undergoing surgery for breast cancer (23) . According to the results, there were no significant differences between the groups in the mean anxiety score before and after the intervention. However, for highly anxious patients (STAI ≥ 51), the STAI score significantly decrease in the multidisciplinary approach group when compared to the group that did not receive this intervention (p = 0.024).
It is worth noting that in the present study and in the aforementioned study (23) the interventions were performed only once, different from other studies in which the interventions were performed over a longer period of time, such as for seven days (24) or three weeks (25) , and which obtained positive results regarding the non-pharmacological interventions tested. Another factor to be taken into consideration is the dynamics of the patient care service in the place where the study was performed. Before participating in the study, the patients, Garcia ACM, Simão-Miranda TP, Carvalho AMP, Elias PCL, Pereira MG, Carvalho EC.
who had a moderate anxiety score (Table 2), had already talked to the medical team about the treatment they would receive. According to the literature, the discussion with the medical team has been a coping strategy widely used by patients who are anxious about the surgical procedure they will undergo (26) . Therefore, it is possible that the clarifications previously offered by the medical team contributed to the levels of anxiety found among study participants.
On the topic of surgical fears, a study that aimed  Table 2). It is possible that therapeutic listening would have a different effect in patients with higher scores, as occurred in a previously mentioned study, in which the intervention tested was effective for the reduction of anxiety only in patients who had high levels of anxiety (23) .
There are reports that the communication between researcher and patient during the data collection moments can contribute to decrease the anxiety levels of the patients, even in individuals of the control groups (28) .
Therefore, the relationship established between the researcher and the patients in these moments may have contributed to the results obtained in the present study, which included a decrease in salivary cortisol, HR and surgical fears in the CG (Table 4). In the nursing care process, actions must go beyond the technical act and be based on the permanent relationship with each other, including touch, communication, physical care and respect, which are fundamental aspects for the promotion of patient well-being (29) .
A possible justification for the changes found in the CG not being observed in the IG is that, in the latter, the Regarding the circadian rhythm of cortisol, it should be considered that tumor patients may exhibit nearly normal or markedly altered circadian rhythms (30) .

Conclusion
The objective of this study was to evaluate the effect of therapeutic listening on state anxiety and surgical fears preoperative colorectal cancer patients.
In the conditions under which the intervention was conducted and considering the state anxiety and surgical fears found in the pre-intervention moment, it was not possible to observe a reduction in the levels of the physiological and psychological variables related to the therapeutic listening.
However, the meeting between the researcher and the patients of the CG for data collection, when there was only the contact without stimulus to reflect on the situation they were experiencing (intervention), may have allowed the reduction of salivary cortisol, HR and surgerical fears. Thus, on the day before the surgical procedure, the care and attitudes offered by the nurse to the patient in this study were efficient in reducing the variables assessed.
One factor that must be taken into account was the time of interaction with the researcher for the therapeutic listening, which was the period between the two moments of data collection (pre-intervention  These aspects deserve further study.
The present study highlights the use of therapeutic listening as a nursing intervention in patients with colorectal cancer in the preoperative period, considering that the use of this intervention may enable a patientcentered information collection, since therapeutic listening puts the patient, and not the disease, as the center of the actions.