Clinical trial NCT03574155: Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors
Official title: Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Keywords: Gynecological cancer
Anxiety
Pre-operative counseling
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 274
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS)

Experimental Group Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)
Primary purpose: TREATMENT

Brief summary: The surgical procedure can be considered a transition in the patient's life. The transition can generate instability and produce negative effects, which may be temporary or permanent. Failure to prepare people to deal with the unexpected, such as diagnosing a disease, such as cancer, and surgical necessity can be a frightening and frustrating experience, developing painful and distressing feelings, involving their family members as well.

Detailed description: A preoperative orientation process with potential benefits to the patient has been adopted for some surgical procedures. However, recently some surgical specialties such as orthopedics have been implemented in their routine a potentially modifiable conduct of the emotional trauma of a surgery, is the use of the preoperative advice and orientation, in order to attain an ability to increase the client's satisfaction, to facilitate the recovery, decrease the rate of complications without increasing reintegration, decrease hospitalization time and health costs without additional patient risk. There is a belief among surgeons that preoperative counseling and counseling is vitally important for a post-operative outcome. Despite this, there is a paucity of well-conducted studies that examine the importance of the need for preoperative counseling with detailed information to analyze the yearnings and needs as well as the emotional impact. In addition, there are few studies evaluating the emotional impact and impact in the postoperative period in general of detailed preoperative counseling in patients with gynecological tumors submitted to laparotomy and minimally invasive surgery. For these reasons, this study aims to evaluate whether the application of detailed and clear preoperative counseling and education about the surgical procedure to be performed, as well as all the perioperative guidelines that involve the procedure versus the usual preoperative orientation and preoperative, can have an impact on the level of anxiety of the patient and the companion, as well as assess the degree of satisfaction of the companion.

Eligibility criteria: Inclusion Criteria:

* Patients submitted to accessory treatment for tumors of the cervix, vulva, ovary or endometrium.
* Primary therapy, which may be radiotherapy or chemotherapy.
* Patients between the ages of 20 and 80 years.
* Patients submitted to a laparotomic or minimally invasive method (robotic and laparoscopic).
* Patients should be treated at the Oncology Gynecology Service of the Barretos Cancer Hospital.

Exclusion Criteria:

* Patients treated at another oncology service previously.
* Patients who have already been treated for some other cancer in the past.
* Patients without a complete primary level and / or who can not read or write.
* Patients and / or family members who refuse to participate in the study.
* Patients who will be admitted to the ICU.

Primary outcomes:
measure: Anxiety levels
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Ricardo Reis
state: São Paulo
Study officials:
References: