Clinical trial NCT02455128: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Fear
Keywords: Anxiety
Fear
Colorectal Surgery
Colorectal Neoplasms
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Patients will be followed on three occasions during the preoperative period, an average of 24 hours before surgery.
Secondary outcomes:
measure: Blood pressure
timeFrame: Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
measure: Heart rate
timeFrame: Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
measure: Respiratory rate
timeFrame: Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
measure: Salivary cortisol
timeFrame: Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery.
measure: Salivary amylase
timeFrame: Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
measure: Surgical Fear Questionnaire (SFQ)
timeFrame: Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery.
Other outcomes:
Locations:
Study officials:
References:
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.