Therapeutic Listening in Patients With Colorectal Cancer

NCT ID: NCT02455128

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-08-31

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.

Conditions

Anxiety; Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

This group will receive the therapeutic listening.

Group Type: EXPERIMENTAL

Therapeutic listening

Intervention Type: OTHER

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

Control Group

This group will receive usual care offered by the hospital where the study will be conducted.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Therapeutic listening

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ana Cláudia Mesquita

Nurse - PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Garcia ACM, Simao-Miranda TP, Carvalho AMP, Elias PCL, Pereira MDG, Carvalho EC. The effect of therapeutic listening on anxiety and fear among surgical patients: randomized controlled trial. Rev Lat Am Enfermagem. 2018 Aug 9;26:e3027. doi: 10.1590/1518-8345.2438.3027.

Reference Type: DERIVED

PMID: 30110103 (View on PubMed)

Other Identifiers

ACM 2015

Identifier Type: -

Identifier Source: org_study_id