Therapeutic Listening in Patients With Colorectal Cancer

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455128
• Other study ID #: ACM 2015
• Status: Completed
• Phase: N/A
• First received: May 16, 2015
• Last updated: August 11, 2017
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Fear

Intervention

Other:
• Therapeutic listening
Method of responding to others in order to encourage better communication and clearer understanding of personal concerns.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.