Therapeutic Listening in Patients With Colorectal Cancer

NCT02455128 | Completed

• 1 other identifier: ACM 2015
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anxiety; Fear

Keywords

Anxiety; Fear; Colorectal Surgery; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Blood pressure

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

• Heart rate

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

• Respiratory rate

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

• Salivary cortisol

  Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery.

• Salivary amylase

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

This group will receive the therapeutic listening.

Other: Therapeutic listening

Control Group

NO INTERVENTION

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

Interventions

Therapeutic listening OTHER

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

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (1)

• 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.

  PMID: 30110103 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse - PhD Student

Study Record Dates

• First Submitted: May 16, 2015
• First Posted: May 27, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: August 1, 2017
• Last Updated: August 15, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share