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

Anxiety Disorders Clinical Trial

Official title:

Impact of Preoperative Counseling and Education in Reducing Anxiety Levels in Patients With Gynecologic Tumors: A Prospective Randomized Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03574155
• Other study ID #: 81886517000005437
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: August 15, 2019

Study information

• Verified date: January 2019
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 274
• Est. completion date: August 15, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Genital Neoplasms, Female

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Ricardo Reis	Barretos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety levels	The investigators will measure anxiety levels using the Hospital Anxiety and Depression Scale.The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.	up to 2 months