Therapeutic Listening in Patients With Colorectal Cancer

University of Sao Paulo50 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anxiety Fear

Interventions

Therapeutic listeningOTHER

Method of responding to others in order to encourage better communication and clearer understanding of personal concerns.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

State-Trait Anxiety Inventory (STAI)

Change in STAI, a questionnaire to assess anxiety levels.

Time frame: Patients will be followed on three occasions during the preoperative period, an average of 24 hours before surgery.

Secondary Outcomes

Blood pressure

Change in Blood Pressure (Systolic and diastolic) (Unit: mmHg).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.

Surgical Fear Questionnaire (SFQ)

Data from ClinicalTrials.gov

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