Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | This group will receive the therapeutic listening. |
|
| Control Group | No Intervention | This group will receive usual care offered by the hospital where the study will be conducted. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic listening | Other | Method of responding to others in order to encourage better communication and clearer understanding of personal concerns. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Change in Blood Pressure (Systolic and diastolic) (Unit: mmHg). | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. |
| Heart rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30110103 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 13, 2018 | |
| Reset | Jan 25, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 13, 2018 | Jan 25, 2019 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in radial pulse (Unit: bpm).
| Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. |
| Respiratory rate | Change in thoracic breathing movements (Unit: bpm). | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. |
| Salivary cortisol | Change in salivary cortisol levels. For the collection of saliva was used Salivette Tube, cotton swab to determine cortisol (Unit: μg/dL). | Patients will be followed on four occasions during the preoperative period, an average of 24 hours before surgery. |
| 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). | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. |
| Surgical Fear Questionnaire (SFQ) | Change in SFQ, a questionnaire to assess the levels of fear of surgery. | Patients will be followed on two occasions during the preoperative period, an average of 24 hours before surgery. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |