Back to resultsTherapeutic Listening in Patients With Colorectal Cancer
Primary Purpose
Anxiety, Fear
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic listening
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Fear, Colorectal Surgery, Colorectal Neoplasms
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
This group will receive the therapeutic listening.
This group will receive usual care offered by the hospital where the study will be conducted.
Outcomes
Primary Outcome Measures
State-Trait Anxiety Inventory (STAI)
Change in STAI, a questionnaire to assess anxiety levels.
Secondary Outcome Measures
Blood pressure
Change in Blood Pressure (Systolic and diastolic) (Unit: mmHg).
Heart rate
Change in radial pulse (Unit: bpm).
Respiratory rate
Change in thoracic breathing movements (Unit: bpm).
Salivary cortisol
Change in salivary cortisol levels. For the collection of saliva was used Salivette Tube, cotton swab to determine cortisol (Unit: μg/dL).
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).
Surgical Fear Questionnaire (SFQ)
Change in SFQ, a questionnaire to assess the levels of fear of surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02455128
Brief Title
Therapeutic Listening in Patients With Colorectal Cancer
Official Title
The Influence of Therapeutic Listening on Anxiety and Fear Related to Surgery in Patients Preoperatively of Colorectal Surgery: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Fear
Keywords
Anxiety, Fear, Colorectal Surgery, Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
This group will receive the therapeutic listening.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will receive usual care offered by the hospital where the study will be conducted.
Intervention Type
Other
Intervention Name(s)
Therapeutic listening
Intervention Description
Method of responding to others in order to encourage better communication and clearer understanding of personal concerns.
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
Change in STAI, a questionnaire to assess anxiety levels.
Time Frame
Patients will be followed on three occasions during the preoperative period, an average of 24 hours before surgery.
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Change in Blood Pressure (Systolic and diastolic) (Unit: mmHg).
Time Frame
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Title
Heart rate
Description
Change in radial pulse (Unit: bpm).
Time Frame
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Title
Respiratory rate
Description
Change in thoracic breathing movements (Unit: bpm).
Time Frame
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Title
Salivary cortisol
Description
Change in salivary cortisol levels. For the collection of saliva was used Salivette Tube, cotton swab to determine cortisol (Unit: μg/dL).
Time Frame
Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery.
Title
Salivary amylase
Description
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).
Time Frame
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Title
Surgical Fear Questionnaire (SFQ)
Description
Change in SFQ, a questionnaire to assess the levels of fear of surgery.
Time Frame
Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30110103
Citation
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.
Results Reference
derived
Learn more about this trial
Therapeutic Listening in Patients With Colorectal Cancer
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