Therapeutic Listening in Patients With Colorectal Cancer

August 11, 2017 updated by: Ana Cláudia Mesquita, University of Sao Paulo

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory (STAI)
Time Frame: 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.
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
Time Frame: 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).
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Heart rate
Time Frame: Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
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
Time Frame: 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).
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Salivary cortisol
Time Frame: 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).
Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery.
Salivary amylase
Time Frame: 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).
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Surgical Fear Questionnaire (SFQ)
Time Frame: 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.
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

May 16, 2015

First Submitted That Met QC Criteria

May 22, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACM 2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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