Therapeutic Listening in Patients With Colorectal Cancer

Not Applicable

Completed

• Conditions: Anxiety; Fear
• Interventions: Other: Therapeutic listening

• Registration Number: NCT02455128
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-05-16
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-27
• Primary Completion: 2015-09
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Therapeutic listening	This group will receive the therapeutic listening.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Salivary amylase	Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.	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).
Surgical Fear Questionnaire (SFQ)	Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.	Change in SFQ, a questionnaire to assess the levels of fear of surgery.
Heart rate	Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.	Change in radial pulse (Unit: bpm).
Respiratory rate	Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.	Change in thoracic breathing movements (Unit: bpm).
Salivary cortisol	Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery.	Change in salivary cortisol levels. For the collection of saliva was used Salivette Tube, cotton swab to determine cortisol (Unit: μg/dL).
Blood pressure	Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.	Change in Blood Pressure (Systolic and diastolic) (Unit: mmHg).