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Completed

NCT Number: NCT02455128

Therapeutic Listening in Patients With Colorectal Cancer

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).

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Key information

Conditions

Anxiety Anxiety Disorders Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Fear Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Mental Disorders Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic listening

Other

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

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI)

    Time frame: 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 outcomes

  1. Blood pressure

    Time frame: 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).

  2. Heart rate

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

    Change in radial pulse (Unit: bpm).

  3. Respiratory rate

    Time frame: 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).

  4. Salivary cortisol

    Time frame: 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).

  5. Salivary amylase

    Time frame: 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).

  6. Surgical Fear Questionnaire (SFQ)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

The Influence of Therapeutic Listening on Anxiety and Fear Related to Surgery in Patients Preoperatively of Colorectal Surgery: a Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
May 27, 2015
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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