Therapeutic Listening in Patients With Colorectal Cancer

Study Overview
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Brief Summary
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This is a randomized clinical trial that aims to investigate the effect of therapeutic listening anxiety and preoperative fear of patients hospitalized for surgical treatment of colorectal cancer. Physiological variables will be evaluated (heart rate, blood pressure and respiratory rate), cortisol and salivary amylase and anxiety scores by State-Trait Anxiety Inventory and fear for Surgery Fear Questionnaire. The data of the variables will be compared at two different times (before and after the intervention).

Detailed Description
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To calculate the sample size was chosen when using numerical scale IDATE. Considering that you want to detect a difference of 10 points (δ) in the range with a significance level of 5% (Z1-α = 1.96), a power of 80% (Z1-β = 1.96). The result obtained was 25 subjects for each group. Information related to variances of control and intervention groups were obtained through the pilot study and a correlation of 0.5 was assumed.

Official Title
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The Influence of Therapeutic Listening on Anxiety and Fear Related to Surgery in Patients Preoperatively of Colorectal Surgery: a Randomized Clinical Trial

Conditions
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Anxiety, Fear

Intervention / Treatment
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* Other: Therapeutic listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be 18 years of age; be hospitalized for performing surgical oncology; not be performing another treatment for cancer; not be participating in another study; be clinically well and / or stable (have score less than or equal to 3 by the Eastern Cooperative Oncology Group - Performance Status). Exclusion Criteria: being illiterate, a condition that will prevent the participant to answer the questionnaires and instruments of the study, which are self-administered; be in possession of psychiatric disorders; be using medication containing corticosteroids.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>This group will receive the therapeutic listening. | Other: Therapeutic listening<br>* Method of responding to others in order to encourage better communication and clearer understanding of personal concerns.<br>|
| No Intervention: Control Group<br>This group will receive usual care offered by the hospital where the study will be conducted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory (STAI) | Change in STAI, a questionnaire to assess anxiety levels. | Patients will be followed on three occasions during the preoperative period, an average of 24 hours before surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Change in Blood Pressure (Systolic and diastolic) (Unit: mmHg). | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | 
| Heart rate | Change in radial pulse (Unit: bpm). | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | 
| Respiratory rate | Change in thoracic breathing movements (Unit: bpm). | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | 
| Salivary cortisol | Change in salivary cortisol levels. For the collection of saliva was used Salivette Tube, cotton swab to determine cortisol (Unit: μg/dL). | Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery. | 
| Salivary amylase | Change in salivary amylase levels. The system for the collection and analysis of salivary amylase comprises a disposable test strip and a portable analyzer, the Cocoro Meter (Unit: KU/L). | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | 
| Surgical Fear Questionnaire (SFQ) | Change in SFQ, a questionnaire to assess the levels of fear of surgery. | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Fear, Colorectal Surgery, Colorectal Neoplasms