Anxiety, Fear
Conditions
Keywords
Anxiety, Fear, Colorectal Surgery, Colorectal Neoplasms
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.
Interventions
Method of responding to others in order to encourage better communication and clearer understanding of personal concerns.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) | Patients will be followed on three occasions during the preoperative period, an average of 24 hours before surgery. | Change in STAI, a questionnaire to assess anxiety levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | Change in radial pulse (Unit: bpm). |
| Respiratory rate | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | Change in thoracic breathing movements (Unit: bpm). |
| Blood pressure | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | Change in Blood Pressure (Systolic and diastolic) (Unit: mmHg). |
| Salivary amylase | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | 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) | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. | Change in SFQ, a questionnaire to assess the levels of fear of surgery. |
| Salivary cortisol | Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery. | Change in salivary cortisol levels. For the collection of saliva was used Salivette Tube, cotton swab to determine cortisol (Unit: μg/dL). |
Outcome results
None listed