Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors

NCT ID: NCT03574155

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2019-08-15

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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control- group

It is composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium, who will receive preoperative and postoperative guidelines according to the usual routine for the perioperative period of the present institution. Patients and their followers of the control group will participate in a preoperative consultation with the surgeon to discuss the indication of the procedure and its risks, benefits and alternatives to the procedure being indicated, if any.

Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group

Composed of patients scheduled for surgical treatment by tumors of the uterine cervix, vulva, ovary or endometrium who will receive preoperative counseling and education through a pre-defined protocol after preoperative consultation with the surgeon. The counseling session will take place with at least one companion. The purpose of this session is to supplement, re-emphasize and strengthen the perioperative guidelines. An illustration (explanatory folder) will be used to demonstrate the location of the surgery, how the scar will be and on which sites of the abdomen and organs the surgery will cover. All this counseling and education will be applied at the same time to the patient and her companion. At the end of the intervention, a space will be left open for both the patient and the companion to ask questions and questions.

Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)

Group Type: EXPERIMENTAL

Pre-operative Counseling and Education

Intervention Type: BEHAVIORAL

Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS) Post-operative Immediate (1 OP) Application of the Questionnaire to assess HADS and ESAS Anxiety (Patient)

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

Late postoperative (2 - 4 weeks) Questioning the patient and companion evaluating the degree of satisfaction regarding the preoperative guidelines.

Interventions

Pre-operative Counseling and Education

Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS) Post-operative Immediate (1 OP) Application of the Questionnaire to assess HADS and ESAS Anxiety (Patient)

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

Late postoperative (2 - 4 weeks) Questioning the patient and companion evaluating the degree of satisfaction regarding the preoperative guidelines.

Intervention Type: BEHAVIORAL

Other Intervention Names

Application of the questionnaire (ESAS) and (HADS)

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ricardo dos Reis

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ricardo Reis

Barretos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

81886517000005437

Identifier Type: -

Identifier Source: org_study_id